CDER Therapeutic Biologic Products
This list is intended to include all the Center for Drug Evaluation and Research (CDER) user fee billable therapeutic biological products and potencies approved under Section 351 of the Public Health Service Act The Orange Book includes a section entitled Drug Products with Approval under Section 505 of the Act Administered by CBER Included on that list are several products that have been transferred to CDER which would be considered billable also
Program fees are assessed for each potency in which the approved (non-revoked non-suspended) product is manufactured in final dosage form When evaluating the specific strength or potency of a drug in final dosage form for purposes of assessing program fees for liquid parenteral biological products CDER intends to take into consideration both the total amount of drug substance in mass or units of activity in a product and the concentration of drug substance (mass or units of activity per unit volume of product) Biologic products considered to have a different strength or potency in a final dosage form will be given separate entries in the Biologics List and assessed separate program fees An auto-injector that has the same strength or potency as a prefilled syringe or vial will generally be assessed a separate prescription drug program fee In certain circumstances products which have been discontinued from marketing but are still licensed are not assessed program fees Those products are identified on the CDER Discontinued Biologic Product List section
The potency information contained in this list is based on information in our database Companies are responsible for alerting CDER to any discrepancies regarding potency information For product approvals after October 1 2005 the Biologics License Application Submission Tracking Number (BLA STN) approval date reflects the approval date of the product For product approvals prior to October 1 2005 the BLA STN approval date reflects the approval date of the original BLA Product Number is the FDA assigned number to identify the application products Each strength is a separate product
The list is updated semi-annually ( Latest Update ndash March 2018 )
CDER Billable Biologic Product List
ApplicantLicense No ABBVIE INC 1889
Trade Name HUMIRA
Proper Name ADALIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125057 0 1 12312002
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
40 MG08 ML ( 50 MGML )
125057 394 2 11232015
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
40 MG04 ML ( 100 MGML )
125057 0 3 12312002
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
10 MG02 ML ( 50 MGML )
125057 0 4 12312002
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
20 MG04 ML ( 50 MGML )
March 2018 Page 1 of 42
CDER Billable Biologic Product List
ApplicantLicense No
125057 0 5
ABBVIE INC 1889
SOLUTION SUBCUTANEOUS AUTOINJECTOR
40 MG08 ML ( 50 MGML )12312002
125057 0 6 12312002
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
10 MG01 ML ( 100 MGML )
125057 0 7 12312002
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
20 MG02 ML ( 100 MGML )
125057 0 8 12312002
SOLUTION SUBCUTANEOUS AUTOINJECTOR
40 MG04 ML ( 100 MGML )
125057 0 9 12312002
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
80 MG08 ML ( 100 MGML )
125057 0 10 12312002
SOLUTION SUBCUTANEOUS AUTOINJECTOR
80 MG08 ML ( 100 MGML )
ApplicantLicense No AEGERION PHARMACEUTICALS INC 2014
Trade Name MYALEPT
Proper Name METRELEPTIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125390 0 1 2242014 113 MG ( 113 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No ALEXION PHARMACEUTICALS INC 1743
Trade Name KANUMA
Proper Name SEBELIPASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125561 0 1 1282015 20 MG10 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name SOLIRIS
March 2018 Page 2 of 42
CDER Billable Biologic Product List
ApplicantLicense No ALEXION PHARMACEUTICALS INC 1743
Proper Name ECULIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125166 0 1 3162007 10 MGML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name STRENSIQ
Proper Name ASFOTASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125513 0 1 10232015 18 MG045 ML ( 40 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
125513 0 2 10232015 80 MG08 ML ( 100 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
125513 0 3 10232015 28 MG07 ML ( 40 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
125513 0 4 10232015 40 MGML ( 40 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No ALLERGAN INC 1145
Trade Name BOTOX
Proper Name BOTULINUM TOXIN TYPE A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103000 0 1 1291991 100 U ( 100 UVIAL )
POWDER INTRAMUSCULAR INTRADERMAL INTRADETRUSOR SINGLE-DOSE VIAL
103000 5101 3 4142005 50 U ( 50 UVIAL )
POWDER INTRAMUSCULAR INTRADERMAL INTRADETRUSOR SINGLE-DOSE VIAL
103000 5122 5 11102005 200 U ( 200 UVIAL )
POWDER INTRAMUSCULAR INTRADERMAL INTRADETRUSOR SINGLE-DOSE VIAL
Trade Name BOTOX COSMETIC
March 2018 Page 3 of 42
CDER Billable Biologic Product List
ApplicantLicense No ALLERGAN INC 1145
Proper Name BOTULINUM TOXIN TYPE A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103000 5000 2 4122002 100 U ( 100 UVIAL )
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
103000 5101 4 4142005 50 U ( 50 UVIAL )
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
Proper Name DARBEPOETIN ALFA IN POLYSORBATE SOLUTION
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103951 0 1 9172001 25 MCGML ( 25 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 2 9172001 40 MCGML ( 40 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 3 9172001 60 MCGML ( 60 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 4 9172001 100 MCGML ( 100 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 5 9172001 150 MCG075 ML ( 150 MCG075 ML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 6 9172001 200 MCGML ( 200 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 7 9172001 300 MCGML ( 300 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 4 of 42
CDER Billable Biologic Product List
ApplicantLicense No AMGEN INC 1080
103951 0 8 9172001 25 MCG042 ML ( 25 MCG042 ML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 9 9172001 40 MCG04 ML ( 40 MCG04 ML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 10 9172001 60 MCG03 ML ( 60 MCG03 ML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 11 9172001 100 MCG05 ML ( 100 MCG05 ML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 12 9172001 150 MCG03 ML ( 150 MCG03 ML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 13 9172001 200 MCG04 ML ( 200 MCG04 ML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 14 9172001 300 MCG06 ML ( 300 MCG06 ML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 15 9172001 500 MCGML ( 500 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 31 9172001 10 MCG04 ML ( 10 MCG04 ML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
Trade Name BLINCYTO
Proper Name BLINATUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125557 0 1 1232014 35 MCG ( 35 MCGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name EPOGEN
Proper Name EPOETIN ALFA
March 2018 Page 5 of 42
CDER Billable Biologic Product List
ApplicantLicense No AMGEN INC 1080
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103234 0 6 611989 10000 UML ( 10000 UML )
SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL
103234 0 7 611989 20000 UML ( 10000 UML )
SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL
Proper Name EPOETIN ALFA - PRESERVATIVE FREE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103234 0 1 611989 2000 UML ( 2000 UML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103234 0 2 611989 3000 UML ( 3000 UML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103234 0 3 611989 4000 UML ( 4000 UML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103234 0 4 611989 10000 UML ( 10000 UML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name NEULASTA
Proper Name PEGFILGRASTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125031 0 1 1312002 6 MG06 ML ( 10 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name NEULASTA ONPRO
Proper Name PEGFILGRASTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125031 181 2 9232015 6 MG06 ML ( 10 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name NEUPOGEN
March 2018 Page 6 of 42
CDER Billable Biologic Product List
ApplicantLicense No AMGEN INC 1080
Proper Name FILGRASTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103353 0 1 2201991 300 MCGML ( 300 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103353 0 2 2201991 300 MCG05 ML ( 600 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103353 0 3 2201991 480 MCG16 ML ( 300 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103353 0 4 2201991 480 MCG08 ML ( 600 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
Trade Name NPLATE
Proper Name ROMIPLOSTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125268 0 1 8222008 250 MCG ( 250 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
125268 0 2 8222008 500 MCG ( 500 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name PROCRIT
Proper Name EPOETIN ALFA - PRESERVATIVE FREE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103234 0 5 611989 40000 UML ( 40000 UML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name PROLIA
Proper Name DENOSUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 7 of 42
CDER Billable Biologic Product List
ApplicantLicense No AMGEN INC 1080
125320 0 1 612010 60 MGML ( 60 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name REPATHA
Proper Name EVOLOCUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125522 0 1 8272015 140 MGML ( 140 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125522 1 2 7112016 420 MG35 ML ( 120 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125522 0 3 8272015 140 MGML ( 140 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name VECTIBIX
Proper Name PANITUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125147 0 1 9272006 100 MG5 ML ( 20 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125147 0 2 9272006 200 MG10 ML ( 20 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125147 0 3 9272006 400 MG20 ML ( 20 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name XGEVA
Proper Name DENOSUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125320 7 2 11182010 120 MG17 ML ( 70 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 8 of 42
CDER Billable Biologic Product List
ApplicantLicense No ASTRAZENECA UK LTD 2043
Trade Name FASENRA
Proper Name BENRALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761070 0 1 11142017
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
30 MGML ( 30 MGML )
Trade Name
Proper Name
IMFINZI
DURVALUMAB
BLASTN
761069 0
Product
1
Approval Date
512017
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
120 MG24 ML ( 50 MGML )
761069 0 2 512017
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
500 MG10 ML ( 50 MGML )
ApplicantLicense No AUXILIUM PHARMACEUTICALS INC 1816
Trade Name XIAFLEX
Proper Name CLOSTRIDIAL COLLAGENASE HISTOLYTICUM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125338 0 1 222010 09 MG ( 09 MGVIAL )
POWDER INTRALESIONAL SINGLE-DOSE VIAL
ApplicantLicense No AYTU BIOSCIENCES INC 2035
Trade Name PROSTASCINT
Proper Name CAPROMAB PENDETIDE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103608 0 1 10281996 05 MGML ( 05 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 9 of 42
CDER Billable Biologic Product List
ApplicantLicense No BAXALTA US INC 2020
Trade Name ONCASPAR
Proper Name PEGASPARGASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103411 0 1 211994 3750 IU5 ML ( 750 IUML )
SOLUTION INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No BAYER HEALTHCARE PHARMACEUTICALS INC 1778
Trade Name BETASERON
Proper Name INTERFERON BETA-1B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103471 0 1 7231993 03 MG ( 03 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No BIOGEN INC 1697
Trade Name AVONEX
Proper Name INTERFERON BETA 1A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103628 0 1 5171996
POWDER INTRAMUSCULAR
30 MCG ( 30 MCGVIAL )
SINGLE-DOSE VIAL
103628 0 2 5171996
SOLUTION INTRAMUSCULAR PREFILLED SYRINGE
30 MCG05 ML ( 30 MCG05 ML )
103628 0 3 5171996
SOLUTION INTRAMUSCULAR AUTOINJECTOR
30 MCG05 ML ( 30 MCG05 ML )
Trade Name
Proper Name
BLASTN
125499 0
PLEGRIDY
PEGINTERFERON BETA-1A
Approval Date PotencyDosage FormRoutePresentation Product
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
63 MCG05 ML ( 126 MCGML ) 8152014 1
March 2018 Page 10 of 42
CDER Billable Biologic Product List
ApplicantLicense No BIOGEN INC 1697
125499 0 2 8152014 125 MCG05 ML ( 250 MCGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125499 0 3 8152014 63 MCG05 ML ( 126 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125499 0 4 8152014 94 MCG05 ML ( 188 MCGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125499 0 5 8152014 94 MCG05 ML ( 188 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125499 0 6 8152014 125 MCG05 ML ( 250 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name TYSABRI
Proper Name NATALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125104 0 1 11232004 300 MG15 ML ( 20 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name ZINBRYTA
Proper Name DACLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761029 0 1 5272016 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
761029 0 2 5272016 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 11 of 42
CDER Billable Biologic Product List
ApplicantLicense No BIOMARIN PHARMACEUTICAL INC 1649
Trade Name ALDURAZYME
Proper Name LARONIDASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125058 0 1 4302003
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
29 MG5 ML ( 058 MGML )
Trade Name
Proper Name
BRINEURA
CERLIPONASE ALFA
BLASTN
761052 0
Product
1
Approval Date
4272017
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENTRICULAR SINGLE-DOSE VIAL
150 MG5 ML ( 30 MGML )
Trade Name
Proper Name
NAGLAZYME
GALSULFASE
BLASTN
125117 0
Product
1
Approval Date
5312005
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
5 MG 5ML ( 1 MGML )
Trade Name
Proper Name
VIMIZIM
ELOSULFASE ALFA
BLASTN
125460 0
Product
1
Approval Date
2142014
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
5 MG5 ML ( 1 MGML )
ApplicantLicense No BOEHRINGER INGELHEIM PHARMACEUTICALS INC 2006
Trade Name PRAXBIND
Proper Name IDARUCIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761025 0 1 10162015 2500 MG50 ML ( 50 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 12 of 42
CDER Billable Biologic Product List
ApplicantLicense No BRISTOL MYERS SQUIBB CO 1713
Trade Name EMPLICITI
Proper Name ELOTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761035 0 1 11302015
POWDER INTRAVENOUS SINGLE-DOSE VIAL
300 MG ( 300 MGVIAL )
761035 0 2 11302015
POWDER INTRAVENOUS SINGLE-DOSE VIAL
400 MG ( 400 MGVIAL )
Trade Name
Proper Name
BLASTN
125288 0
NULOJIX
BELATACEPT
Approval Date Product
6152011 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
250 MG ( 250 MGVIAL )
Trade Name
Proper Name
BLASTN
125554 0
OPDIVO
NIVOLUMAB
Approval Date Product
12222014 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
40 MG4 ML ( 10 MGML )
125554 0 2 12222014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG10 ML ( 10 MGML )
125554 0 3 12222014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
240 MG24 ML ( 10 MGML )
Trade Name
Proper Name
BLASTN
125118 0
ORENCIA
ABATACEPT
Approval Date Product
12232005 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
250 MG ( 250 MGVIAL )
March 2018 Page 13 of 42
CDER Billable Biologic Product List
ApplicantLicense No BRISTOL MYERS SQUIBB CO 1713
125118 122 2 7292011 50 MG04 ML ( 125 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125118 122 3 7292011 875 MG07 ML ( 125 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125118 122 4 7292011 125 MGML ( 125 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125118 122 5 7292011 125 MGML ( 125 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name YERVOY
Proper Name IPILIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125377 0 1 3252011 50 MG10 ML ( 5 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125377 0 2 3252011 200 MG40 ML ( 5 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No BTG INTERNATIONAL INC 1861
Trade Name VORAXAZE
Proper Name GLUCARPIDASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125327 0 1 1172012 1000 U ( 1000 UVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 14 of 42
CDER Billable Biologic Product List
ApplicantLicense No DYAX CORPORATION 1789
Trade Name KALBITOR
Proper Name ECALLANTIDE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125277 0 1 1212009 10 MGML ( 10 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No EKR THERAPEUTICS INC 1814
Trade Name RETAVASE
Proper Name RETEPLASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103786 0 1 561998 10 U ( 10 UVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No ELI LILLY AND CO 1891
Trade Name CYRAMZA
Proper Name RAMUCIRUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125477 0 1 4212014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG10 ML ( 10 MGML )
125477 0 2 4212014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
500 MG50 ML ( 10 MGML )
Trade Name
Proper Name
BLASTN
761038 0
LARTRUVO
OLARATUMAB
Approval Date Product
10192016 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
500 MG50 ML ( 10 MGML )
761038 0 2 10192016
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
190 MG19 ML ( 10 MGML )
March 2018 Page 15 of 42
CDER Billable Biologic Product List
ApplicantLicense No ELI LILLY AND CO 1891
Trade Name PORTRAZZA
Proper Name NECITUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125547 0 1 11242015
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
800 MG50 ML ( 16 MGML )
Trade Name
Proper Name
TALTZ
IXEKIZUMAB
BLASTN
125521 0
Product
1
Approval Date
3222016
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
80 MGML ( 80 MGML )
125521 0 2 3222016
SOLUTION SUBCUTANEOUS AUTOINJECTOR
80 MGML ( 80 MGML )
Trade Name
Proper Name
TRULICITY
DULAGLUTIDE
BLASTN
125469 0
Product
1
Approval Date
9182014
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
075 MG05 ML ( 075 MG05 ML )
125469 0 2 9182014
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
15 MG05 ML ( 15 MG05 ML )
125469 0 3 9182014
SOLUTION SUBCUTANEOUS AUTOINJECTOR
075 MG05 ML ( 075 MG05 ML )
125469 0 4 9182014
SOLUTION SUBCUTANEOUS AUTOINJECTOR
15 MG05 ML ( 15 MG05 ML )
March 2018 Page 16 of 42
CDER Billable Biologic Product List
ApplicantLicense No ELUSYS THERAPEUTICS INC 1907
Trade Name ANTHIM
Proper Name OBILTOXAXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125509 1 1 3182016 600 MG6 ML ( 100 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No EMD SERONO INC 1773
Trade Name BAVENCIO
Proper Name AVELUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761049 0 1 3232017
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
200 MG10 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
103780 0
REBIF
INTERFERON BETA 1A
Approval Date Product
372002 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
88 MCG02 ML ( 44 MCGML )
103780 0 2 372002
SOLUTION SUBCUTANEOUS AUTOINJECTOR
88 MCG02 ML ( 44 MCGML )
103780 0 3 372002
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
22 MCG05 ML ( 44 MCGML )
103780 0 4 372002
SOLUTION SUBCUTANEOUS AUTOINJECTOR
22 MCG05 ML ( 44 MCGML )
103780 0 5 372002
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
44 MCG05 ML ( 88 MCGML )
103780 0 6 372002
SOLUTION SUBCUTANEOUS AUTOINJECTOR
44 MCG05 ML ( 88 MCGML )
March 2018 Page 17 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name ACTEMRA
Proper Name TOCILIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125276 0 1 182010
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
80 MG4 ML ( 20 MGML )
125276 0 2 182010
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
200 MG10 ML ( 20 MGML )
125276 0 3 182010
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
400 MG20 ML ( 20 MGML )
BLASTN
125472 1
Product
1
Approval Date
10212013
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
162 MG09 ML ( 179 MGML )
Trade Name
Proper Name
BLASTN
103172 0
ACTIVASE
ALTEPLASE
Approval Date Product
11131987 2
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
50 MG ( 50 MGVIAL )
103172 0 3 11131987
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
BLASTN
125085 0
AVASTIN
BEVACIZUMAB
Approval Date Product
2262004 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG4 ML ( 25 MGML )
125085 0 2 2262004
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
400 MG16 ML ( 25 MGML )
March 2018 Page 18 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name CATHFLO ACTIVASE
Proper Name ALTEPLASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103172 0 1 11131987
POWDER INTRACATHETER SINGLE-DOSE VIAL
2 MG ( 2 MGVIAL )
Trade Name
Proper Name
BLASTN
125486 0
GAZYVA
OBINUYUZUMAB
Approval Date Product
1112013 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1000 MG40 ML ( 25 MGML )
Trade Name
Proper Name
BLASTN
761083 0
HEMLIBRA
EMICIZUMAB-KXWH
Approval Date Product
11162017 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML )
761083 0 2 11162017
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
60 MG04 ML ( 150 MGML )
761083 0 3 11162017
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
105 MG07 ML ( 150 MGML )
761083 0 4 11162017
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
150 MGML ( 150 MGML )
Trade Name
Proper Name
BLASTN
103792 0
HERCEPTIN
TRASTUZUMAB
Approval Date Product
9251998 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS MULTI-DOSE VIAL
420 MG ( 420 MGVIAL )
March 2018 Page 19 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
103792 5336 2 2102017 150 MG ( 150 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name KADCYLA
Proper Name ADO-TRASIUZUMAB EMTANSINE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125427 0 1 2222013
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
125427 0 2 2222013
POWDER INTRAVENOUS SINGLE-DOSE VIAL
160 MG ( 160 MGVIAL )
Trade Name
Proper Name
LUCENTIS
RANIBIZUMAB
BLASTN
125156 0
Product
1
Approval Date
6302006
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE
05 MG005 ML ( 10 MGML )
Proper Name RANIDIZUMAB
BLASTN
125156 076
Product
2
Approval Date
8102012
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE
03 MG005 ML ( 6 MGML )
Trade Name
Proper Name
OCREVUS
OCRELIZUMAB
BLASTN
761053 0
Product
1
Approval Date
3282017
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
300 MG10 ML ( 30 MGML )
Trade Name
Proper Name
PERJETA
PERTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 20 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
125409 0 1 682012 420 MG14 ML ( 30 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name PULMOZYME
Proper Name DORNASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103532 0 1 12301993 25 MG25 ML ( 1 MGML )
SOLUTION INHALATION AMPULE
Trade Name RITUXAN
Proper Name RITUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103705 0 1 11261997 100 MG10 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
103705 0 2 11261997 500 MG50 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name RITUXAN HYCELA
Proper Name RITUXIMAB AND HYALURONIDASE HUMAN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761064 0 1 6222017 1400 MG AND 23400 U117 ML ( 11966 MG AND 2000 UML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
761064 0 2 6222017 1600 MG AND 26800 U134 ML ( 11966 MG AND 2000 UML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name TECENTRIQ
Proper Name ATEZOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761034 0 1 582016 1200 MG20 ML ( 60 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name TNKASE
March 2018 Page 21 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Proper Name TENECTEPLASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103909 0 1 622000 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103976 0 1 6202003 150 MG ( 150 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103948 0 1 572001
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML )
Trade Name
Proper Name
FABRAZYME
AGALSIDASE BETA
BLASTN
103979 0
Product
1
Approval Date
4242003
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
5 MG ( 5 MGVIAL )
103979 0 2 4242003
POWDER INTRAVENOUS SINGLE-DOSE VIAL
35 MG ( 35 MGVIAL )
Trade Name
Proper Name
LEMTRADA
ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 22 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENZYME CORP 1596
103948 5139 2 11142014 12 MG12 ML ( 10MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name LUMIZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125291 0 1 5242010 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name NUCALA
Proper Name MEPOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125526 0 1 11142015
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
TANZEUM
ALBIGLUTIDE
BLASTN
125431 0
Product
1
Approval Date
4152014
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS AUTOINJECTOR
30 MG ( 30 MGAUTOINJECTOR )
125431 0 2 4152014
POWDER SUBCUTANEOUS AUTOINJECTOR
50 MG ( 50 MGAUTOINJECTOR )
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name PEGASYS
Proper Name PEGINTERFERON ALFA 2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103964 5204 4 9292011 180 MCG05 ML ( 360 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 23 of 42
CDER Billable Biologic Product List
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Proper Name PEG-INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103964 0 1 10162002 180 MCGML ( 180 MCGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
103964 0 2 10162002 180 MCG05 ML ( 360 MCGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
103964 5204 3 9292011 135 MCG05 ML ( 270 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
ApplicantLicense No HORIZON PHARMA IRELAND LTD 2022
Trade Name ACTIMMUNE
Proper Name INTERFERON GAMMA-1B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103836 0 1 2251999 100 MCG05 ML ( 200 MCGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No HORIZON PHARMA RHEUMATOLOGY LLC 1998
Trade Name KRYSTEXXA
Proper Name PEGLOTICASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125293 0 1 9142010 8MGML ( 8MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 24 of 42
CDER Billable Biologic Product List
ApplicantLicense No HUMAN GENOME SCIENCES INC 1820
Trade Name BENLYSTA
Proper Name BELIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125370 0 1 392011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
120 MG ( 120 MGVIAL )
125370 0 2 392011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
400 MG ( 400 MGVIAL )
125370 0 3 392011
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )
125370 0 4 392011
SOLUTION SUBCUTANEOUS AUTOINJECTOR
200 MGML ( 200 MGML )
BLASTN
761043 0
Product
1
Approval Date
7202017
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )
Trade Name
Proper Name
RAXIBACUMAB
RAXIBACUMAB
BLASTN
125349 0
Product
1
Approval Date
12142012
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1700 MG34 ML ( 50 MGML )
ApplicantLicense No IMCLONE LLC 1695
Trade Name ERBITUX
Proper Name CETUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125084 0 1 2122004 100 MG50 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 25 of 42
CDER Billable Biologic Product List
ApplicantLicense No IMCLONE LLC 1695
125084 0 2 2122004 200 MG100 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No IMMUNEX CORP 1132
Trade Name ENBREL
Proper Name ETANERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103795 0 1 1121998
POWDER SUBCUTANEOUS MULTI-DOSE VIAL
25 MG ( 25 MGVIAL )
103795 5184 2 9272004
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
50 MGML ( 50 MGML )
103795 0 3 9272004
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MGML ( 50 MGML )
103795 5184 4 9272004
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
25 MG05 ML ( 50 MGML )
103795 5556 5 9142017
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MGML ( 50 MGML )
ApplicantLicense No IPSEN BIOPHARM LIMITED 1787
Trade Name DYSPORT
Proper Name ABOBOTULINUMTOXINA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125274 0 1 4292009
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
300 UNITS ( 300 UNITSVIAL )
125274 0 2 4292009
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
500 UNITS ( 500 UNITSVIAL )
March 2018 Page 26 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
Trade Name DARZALEX
Proper Name DARATUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761036 0 1 11162015
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG5 ML ( 20 MGML )
761036 0 2 11162015
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
400 MG20 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
103772 0
REMICADE
INFLIXIMAB
Approval Date Product
8241998 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
BLASTN
103575 0
REOPRO
ABCIXIMAB
Approval Date Product
12221994 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
10 MG5 ML ( 2 MGML )
Trade Name
Proper Name
BLASTN
125289 0
SIMPONI
GOLIMUMAB
Approval Date Product
4242009 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
50 MG05 ML ( 100 MGML )
125289 0 2 4242009
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MG05 ML ( 100 MGML )
125289 0 3 4242009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
100 MGML ( 100 MGML )
March 2018 Page 27 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
125289 0 4 4242009 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name SIMPONI ARIA
Proper Name GOLIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125433 0 1 7182013 50 MG4 ML ( 125 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name STELARA
Proper Name USTEKINUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125261 0 1 9252009 90 MGML ( 90 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125261 0 2 9252009 45 MG05 ML ( 90 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL amp PREFILLED SYRINGE
125261 0 3 9252009 130 MG26 ML ( 5 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761044 0 1 9232016 130 MG26 ML ( 5 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SYLVANT
Proper Name SILTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125496 0 1 4232014 100 MG ( 100 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125496 0 2 4232014 400 MG ( 400 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 28 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
Trade Name TREMFYA
Proper Name GUSELKUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761061 0 1 7132017 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No JAZZ PHARMACEUTICALS INC 1901
Trade Name ERWINAZE
Proper Name ASPARAGINASE ERWINIA CHRYSANTHEMI
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
105359 0 1 11182011 10000 IU ( 10000 IUVIAL )
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103770 0 1 6191998
SOLUTION INTRAMUSCULAR
50 MG05 ML ( 100 MGML )
SINGLE-DOSE VIAL
103770 0 2 6191998
SOLUTION INTRAMUSCULAR
100 MGML ( 100 MGML )
SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name ILUMYA
Proper Name TILDRAKIZUMAB-ASMN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761067 0 1 3202018 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name INTRON A
March 2018 Page 29 of 42
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103132 0 1 641986 10 MIU ( 10 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL INTRAVENOUS SINGLE-DOSE VIAL
103132 0 2 641986 18 MIU ( 18 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL
103132 0 3 641986 50 MIU ( 50 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL
103132 0 4 641986 228 MIU38 ML ( 6 MIUML )
SOLUTION INTRAMUSCULAR SUBCUTANEOUS MULTI-DOSE VIAL
103132 0 5 641986 32 MIU32 ML ( 10 MIUML )
SOLUTION INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL MULTI-DOSE VIAL
Trade Name KEYTRUDA
Proper Name PEMBROLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125514 0 1 942014 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125514 1 2 1152015 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 0 1 1192001 74 MCG ( 74 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SYLATRON
Proper Name PEGINTERFERON ALFA-2B
March 2018 Page 30 of 42
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 5153 2 3292011 296 MCG ( 296 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 3 3292011 444 MCG ( 444 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 4 3292011 888 MCG ( 888 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name ZINPLAVA
Proper Name BEZLOTOXUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761046 0 1 10212016 1000 MG40 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No MERZ PHARMACEUTICALS GMBH 1830
Trade Name XEOMIN
Proper Name INCOBOTULINUMTOXINA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125360 0 1 7302010
POWDER INTRAMUSCULAR
50 U ( 50 UVIAL )
SINGLE-DOSE VIAL
125360 0 2 7302010
POWDER INTRAMUSCULAR
100 U ( 100 UVIAL )
SINGLE-DOSE VIAL
125360 3 3 11202015
POWDER INTRAMUSCULAR
200 U ( 200 UVIAL )
SINGLE-DOSE VIAL
March 2018 Page 31 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
Trade Name ARZERRA
Proper Name OFATUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125326 0 1 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG5 ML ( 20 MGML )
125326 0 2 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1000 MG50 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
125504 0
COSENTYX
SECUKINUMAB
Approval Date Product
1212015 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
150 MG ( 150 MGVIAL )
125504 0 2 1212015
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MGML ( 150 MGML )
125504 0 3 1212015
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MGML ( 150 MGML )
Trade Name
Proper Name
BLASTN
125290 0
EXTAVIA
INTERFERON BETA-1B
Approval Date Product
8142009 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
03 MG ( 03 MGVIAL )
Trade Name
Proper Name
BLASTN
125319 0
ILARIS
CANAKINUMAB
Approval Date Product
6172009 1
PotencyDosage FormRoutePresentation
180 MGVIAL ( 180 MGVIAL )
March 2018 Page 32 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
125319 88 2 12222016 150 MG ( 150 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
125319 0 3 12222016 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SIMULECT
Proper Name BASILIXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103764 0 1 5121998 10 MG ( 10 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
103764 0 2 5121998 20 MG ( 20 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No NPS PHARMACEUTICALS INC 1908
Trade Name NATPARA
Proper Name PARATHYROID HORMONE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 33 of 42
CDER Billable Biologic Product List
ApplicantLicense No PROMETHEUS LABORATORIES INC 1848
Trade Name PROLEUKIN
Proper Name ALDESLEUKIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103293 0 1 551992 22 MIU ( 22 MIUVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760
Trade Name ARCALYST
Proper Name RILONACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125249 0 1 2272008
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
220MG ( 220MGVIAL )
Trade Name
Proper Name
DUPIXENT
DUPILUMAB
BLASTN
761055 0
Product
1
Approval Date
3282017
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
300 MG2 ML ( 150 MGML )
Trade Name
Proper Name
EYLEA
AFLIBERCEPT
BLASTN
125387 0
Product
1
Approval Date
11182011
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
2 MG005 ML ( 40 MGML )
March 2018 Page 34 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Trade Name ELITEK
Proper Name RASBURICASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103946 0 1 7122002
POWDER INTRAVENOUS SINGLE-DOSE VIAL
15 MG ( 15 MGVIAL )
103946 5020 2 162006
POWDER INTRAVENOUS SINGLE-DOSE VIAL
75 MG ( 75 MGVIAL )
Trade Name
Proper Name
BLASTN
761037 0
KEVZARA
SARILUMAB
Approval Date Product
5222017 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MG114 ML ( 13158 MGML )
761037 0 2 5222017
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MG114 ML ( 17544 MGML )
761037 1 3 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MG114 ML ( 13158 MGML )
761037 1 4 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
200 MG114 ML ( 17544 MGML )
Trade Name
Proper Name
BLASTN
103362 0
LEUKINE
SARGRAMOSTIM
Approval Date Product
351991 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
250 MCG ( 250 MCGVIAL )
103362 0 2 351991
SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL
500 MCGML ( 500 MCGML )
Trade Name PRALUENT
March 2018 Page 35 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Proper Name ALIROCUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125559 0 1 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 2 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 3 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125559 0 4 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name ZALTRAP
Proper Name ZIV-AFLIBERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125418 0 1 832012 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125418 0 2 832012 200 MG8 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SEATTLE GENETICS INC 1853
Trade Name ADCETRIS
Proper Name BRENTUXIMAB VEDOTIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125388 1 1 8192011 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 36 of 42
CDER Billable Biologic Product List
ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593
Trade Name ELAPRASE
Proper Name IDURSULFASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125151 0 1 7242006 6 MG3 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SICOR BIOTECH UAB 1803
Trade Name GRANIX
Proper Name TBO-FILGRASTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125294 0 1 8292012
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
300 MCG0 5 ML ( 600 MCGML )
125294 0 2 8292012
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
480 MCG08 ML ( 600 MCGML )
ApplicantLicense No SMITH AND NEPHEW INC 2004
Trade Name REGRANEX
Proper Name BECAPLERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103691 0 1 12161997
GEL TOPICAL
100 UG ( 100 UGGM )
Trade Name
Proper Name
SANTYL
COLLAGENASE
BLASTN
101995 0
Product
1
Approval Date
641965
PotencyDosage FormRoutePresentation
OINTMENT TOPICAL
30 G amp 90 G TUBE ( 250 UGRAM )
March 2018 Page 37 of 42
CDER Billable Biologic Product List
ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718
Trade Name MYOBLOC
Proper Name RIMABOTULINUM TOXIN B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103846 0 1 1282002
SOLUTION INTRAMUSCULAR
2500 IU05 ML ( 5000 IUML )
SINGLE-DOSE VIAL
103846 0 3 1282002
SOLUTION INTRAMUSCULAR
10000 IU2 ML ( 5000 IUML )
SINGLE-DOSE VIAL
Proper Name RIMABOTULINUMTOXINB
BLASTN
103846 0
Product
2
Approval Date
1282002
PotencyDosage FormRoutePresentation
SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL
5000 IUML ( 5000 IUML )
ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832
Trade Name ZEVALIN
Proper Name IBRITUMOMAB TIUXETAN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125019 0 1 2192002 32 MG2 ML ( 16 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
Trade Name KEPIVANCE
Proper Name PALIFERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125103 0 1 12152004 625 MG ( 625 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name KINERET
Proper Name ANAKINRA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 38 of 42
CDER Billable Biologic Product List
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898
Trade Name ENTYVIO
Proper Name VEDOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125476 0 1 5202014 300 MG ( 300 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No TEVA RESPIRATORY LLC 2047
Trade Name CINQAIR
Proper Name RESLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761033 0 1 3232016 100 MG10 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No THERATECHNOLOGIES INC 2091
Trade Name TROGARZO
Proper Name IBALIZUMAB-UIYK
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761065 0 1 362018 200 MG133 ML ( 150 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 39 of 42
CDER Billable Biologic Product List
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
0375 MG03 ML ( 125 MGML )2222017 125422 038 1
ApplicantLicense No UCB INC 1736
Trade Name CIMZIA
Proper Name CERTOLIZUMAB PEGOL
BLASTN Approval Date PotencyDosage FormRoutePresentation Product
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
200 MG ( 200 MGVIAL ) 4222008 125160 0 1
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )5132009 125160 080 2
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
Trade Name CRYSVITA
Proper Name BUROSUMAB-TWZA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761068 0 1 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
10 MGML ( 10 MGML )
761068 0 2 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
20 MGML ( 20 MGML )
761068 0
Trade Name
Proper Name
BLASTN
March 2018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML ) 4172018 3
MEPSEVII
VESTRONIDASE ALFA-VJBK
Approval Date PotencyDosage FormRoutePresentation Product
Page 40 of 42
CDER Billable Biologic Product List
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
761047 0 1 11152017 10 MG5 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No UNITED THERAPEUTICS CORP 1993
Trade Name UNITUXIN
Proper Name DINUTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125516 0 1 3102015 175 MG5 ML ( 35 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053
Trade Name SILIQ
Proper Name BRODALUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761032 0 1 2152017 210 MG15 ML ( 140 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 41 of 42
CDER Billable Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No WYETH PHARMACEUTICALS INC 0003
Trade Name BESPONSA
Proper Name INOTUZUMAB OZOGAMICIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761040 0 1 8172017 09 MG ( 09 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 42 of 42
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 1 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
9172001 103951 0 26
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
200 MCGML ( 200 MCGML ) 09272012
103951 0 27 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
200 MCG04 ML ( 500 MCGML ) 09272012
103951 0 28 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
300 MCGML ( 300 MCGML ) 09272012
103951 0 29 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
300 MCG06 ML ( 500 MCGML ) 09272012
103951 0 30 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
500 MCGML ( 500 MCGML ) 09272012
ApplicantLicense No ASTELLAS PHARMACEUTICALS US INC 1748
Trade Name AMEVIVE
Proper Name ALEFACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125036 0 1 1302003 75 MGVIAL ( 75 MGVIAL ) 09242008
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
125036 0 2 1302003 15 MGVIAL ( 15 MGVIAL ) 09282012
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No BOEHRINGER INGELHEIM PHARMA KG 1251
Trade Name VERLUMA
Proper Name NOFETUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103769 0 1 10131998 10 MGML ( 10 MGML ) 08132013
INTRAVENOUS
March 2018 Page 2 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No CENTOCOR ORTHO BIOTECH PRODUCTS LP 1824
Trade Name ORTHOCLONE OKT3
Proper Name MUROMONAB-CD3
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103463 0 1 9141992 1 MGML ( 1 MGML ) 01112012
SOLUTION INTRAVENOUS AMPULE
ApplicantLicense No EISAI INCORPORATED 1862
Trade Name ONTAK
Proper Name DENILEUKIN DIFTITOX
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103767 0 1 251999 300 MCG2 ML ( 150 MCGML ) 01302014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No ELI LILLY AND CO 1611
Trade Name XIGRIS
Proper Name DROTRECOGIN ALFA (ACTIVATED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125029 0 1 11212001 5 MGVIAL ( 5 MGVIAL ) 10262011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125029 0 2 11212001 20 MGVIAL ( 20 MGVIAL ) 10102011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GENENTECH INC 1048
Trade Name RAPTIVA
Proper Name EFALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125075 0 1 10272003 125 MGVIAL ( 125 MGVIAL ) 09012009
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
March 2018 Page 3 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103976 0 2 6202003 125 MGVIAL ( 125 MGVIAL ) 08252016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103948 0 3 572001 10 MGVIAL ( 10 MGVIAL ) 07062011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name MYOZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125141 0 1 4282006 50 MGVIAL ( 50 MGVIAL ) 10172014
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name BEXXAR THERAPEUTIC REGIME
Proper Name TOSITUMOMAB AND IODINE I-131 TOSITUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125011 0 1 6272003 01 MGML I-131 TOSITUMOMAB ( 01 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 2 6272003 11 MGML I-131 TOSITUMOMAB ( 11 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 3 6272003 14 MGML TOSITUMOMAB ( 14 MGML 03102014 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 4 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No HEMISPHERX BIOPHARMA INC 1703
Trade Name ALFERON N INJECTION
Proper Name INTERFERON ALFA-N3 (HUMAN LEUKOCYTE DERIVED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103158 0 1 10101989 5 MIUVIAL ( 5 MIUVIAL ) 06272013
SOLUTION INTRALESIONAL MULTI-DOSE VIAL
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name ROFERON A
Proper Name INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103145 0 1 641986 3 MIU05 ML ( 3 MIU05 ML ) 06012009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name ZENAPAX
Proper Name DACLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103749 0 1 12101997 25 MG5 ML ( 25 MG5 ML ) 07072011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No KADMON PHARMACEUTICALS LLC 1867
Trade Name INFERGEN
Proper Name INTERFERON ALFACON-1
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103663 0 1 1061997 9 MCG03 ML ( 30 MCGML ) 07252013
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 5 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103770 0 3 6191998 50 MGVIAL ( 50 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
103770 0 4 6191998 100 MGVIAL ( 100 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name INTRON A
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103132 0 6 641986 10 MIUML ( 10 MIUML ) 09232013
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103132 0 7 641986 225 MIU15 ML ( 225 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 8 641986 375 MIU15 ML ( 375 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 9 641986 75 MIU15 ML ( 75 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103949 0 5 1192001 675 MCGPEN ( 675 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 6 1192001 108 MCGPEN ( 108 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
March 2018 Page 6 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name PEGINTRON
103949 0 7 1192001 1184 MCGVIAL ( 1184 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 8 1192001 162 MCGPEN ( 162 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 9 1192001 1776 MCGVIAL ( 1776 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 10 1192001 2025 MCGPEN ( 2025 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 11 1192001 222 MCGVIAL ( 222 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No PALATIN TECHNOLOGIES INC 1588
Trade Name NEUTROSPEC TECHNETIUM (99M TC)
Proper Name FANOLESOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103928 0 1 722004 025 MGVIAL ( 025 MGVIAL ) 09222008
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No RECORDATI RARE DISEASES INC 1899
Trade Name ELSPAR
Proper Name ASPARAGINASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
101063 0 1 1101978 10000 IU ( 10000 IUVIAL ) 04092014
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
March 2018 Page 7 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No SCHERING CORP 0994
Trade Name PEGINTRONREBETOL COMBO PACK
Proper Name PEGINTERFERON ALFA-2B AND RIBAVIRIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125196 0 1 6132008 ( 4 (120 MCG05ML) REDIPEN amp 140 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 2 6132008 ( 4 (150 MCG05ML) REDIPEN amp 168 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 3 6132008 ( 4 (150 MCG05ML) REDIPEN amp 196 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 4 6132008 ( 4 (50 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 5 6132008 ( 4 (80 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125422 0 2 10172012 05 MG ( 25 MGML ) 08082017
SOLUTION INTRAVETREAL SINGLE-DOSE VIAL
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125164 0 10 11142007 50 MCGML ( 50 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 8 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
125164 0 11 11142007 100 MCGML ( 100 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 12 11142007 200 MCGML ( 200 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 13 11142007 300 MCGML ( 300 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 14 11142007 400 MCGML ( 400 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 15 11142007 400 MCG06 ML ( 400 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 16 11142007 600 MCGML ( 600 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 17 11142007 600 MCG06 ML ( 600 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 18 11142007 800 MCG06 ML ( 800 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 19 11142007 1000 MCGML ( 1000 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 9 of 9
CDER Billable Biologic Product List
ApplicantLicense No
125057 0 5
ABBVIE INC 1889
SOLUTION SUBCUTANEOUS AUTOINJECTOR
40 MG08 ML ( 50 MGML )12312002
125057 0 6 12312002
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
10 MG01 ML ( 100 MGML )
125057 0 7 12312002
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
20 MG02 ML ( 100 MGML )
125057 0 8 12312002
SOLUTION SUBCUTANEOUS AUTOINJECTOR
40 MG04 ML ( 100 MGML )
125057 0 9 12312002
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
80 MG08 ML ( 100 MGML )
125057 0 10 12312002
SOLUTION SUBCUTANEOUS AUTOINJECTOR
80 MG08 ML ( 100 MGML )
ApplicantLicense No AEGERION PHARMACEUTICALS INC 2014
Trade Name MYALEPT
Proper Name METRELEPTIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125390 0 1 2242014 113 MG ( 113 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No ALEXION PHARMACEUTICALS INC 1743
Trade Name KANUMA
Proper Name SEBELIPASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125561 0 1 1282015 20 MG10 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name SOLIRIS
March 2018 Page 2 of 42
CDER Billable Biologic Product List
ApplicantLicense No ALEXION PHARMACEUTICALS INC 1743
Proper Name ECULIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125166 0 1 3162007 10 MGML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name STRENSIQ
Proper Name ASFOTASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125513 0 1 10232015 18 MG045 ML ( 40 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
125513 0 2 10232015 80 MG08 ML ( 100 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
125513 0 3 10232015 28 MG07 ML ( 40 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
125513 0 4 10232015 40 MGML ( 40 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No ALLERGAN INC 1145
Trade Name BOTOX
Proper Name BOTULINUM TOXIN TYPE A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103000 0 1 1291991 100 U ( 100 UVIAL )
POWDER INTRAMUSCULAR INTRADERMAL INTRADETRUSOR SINGLE-DOSE VIAL
103000 5101 3 4142005 50 U ( 50 UVIAL )
POWDER INTRAMUSCULAR INTRADERMAL INTRADETRUSOR SINGLE-DOSE VIAL
103000 5122 5 11102005 200 U ( 200 UVIAL )
POWDER INTRAMUSCULAR INTRADERMAL INTRADETRUSOR SINGLE-DOSE VIAL
Trade Name BOTOX COSMETIC
March 2018 Page 3 of 42
CDER Billable Biologic Product List
ApplicantLicense No ALLERGAN INC 1145
Proper Name BOTULINUM TOXIN TYPE A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103000 5000 2 4122002 100 U ( 100 UVIAL )
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
103000 5101 4 4142005 50 U ( 50 UVIAL )
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
Proper Name DARBEPOETIN ALFA IN POLYSORBATE SOLUTION
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103951 0 1 9172001 25 MCGML ( 25 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 2 9172001 40 MCGML ( 40 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 3 9172001 60 MCGML ( 60 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 4 9172001 100 MCGML ( 100 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 5 9172001 150 MCG075 ML ( 150 MCG075 ML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 6 9172001 200 MCGML ( 200 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 7 9172001 300 MCGML ( 300 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 4 of 42
CDER Billable Biologic Product List
ApplicantLicense No AMGEN INC 1080
103951 0 8 9172001 25 MCG042 ML ( 25 MCG042 ML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 9 9172001 40 MCG04 ML ( 40 MCG04 ML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 10 9172001 60 MCG03 ML ( 60 MCG03 ML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 11 9172001 100 MCG05 ML ( 100 MCG05 ML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 12 9172001 150 MCG03 ML ( 150 MCG03 ML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 13 9172001 200 MCG04 ML ( 200 MCG04 ML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 14 9172001 300 MCG06 ML ( 300 MCG06 ML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 15 9172001 500 MCGML ( 500 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 31 9172001 10 MCG04 ML ( 10 MCG04 ML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
Trade Name BLINCYTO
Proper Name BLINATUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125557 0 1 1232014 35 MCG ( 35 MCGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name EPOGEN
Proper Name EPOETIN ALFA
March 2018 Page 5 of 42
CDER Billable Biologic Product List
ApplicantLicense No AMGEN INC 1080
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103234 0 6 611989 10000 UML ( 10000 UML )
SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL
103234 0 7 611989 20000 UML ( 10000 UML )
SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL
Proper Name EPOETIN ALFA - PRESERVATIVE FREE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103234 0 1 611989 2000 UML ( 2000 UML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103234 0 2 611989 3000 UML ( 3000 UML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103234 0 3 611989 4000 UML ( 4000 UML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103234 0 4 611989 10000 UML ( 10000 UML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name NEULASTA
Proper Name PEGFILGRASTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125031 0 1 1312002 6 MG06 ML ( 10 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name NEULASTA ONPRO
Proper Name PEGFILGRASTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125031 181 2 9232015 6 MG06 ML ( 10 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name NEUPOGEN
March 2018 Page 6 of 42
CDER Billable Biologic Product List
ApplicantLicense No AMGEN INC 1080
Proper Name FILGRASTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103353 0 1 2201991 300 MCGML ( 300 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103353 0 2 2201991 300 MCG05 ML ( 600 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103353 0 3 2201991 480 MCG16 ML ( 300 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103353 0 4 2201991 480 MCG08 ML ( 600 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
Trade Name NPLATE
Proper Name ROMIPLOSTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125268 0 1 8222008 250 MCG ( 250 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
125268 0 2 8222008 500 MCG ( 500 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name PROCRIT
Proper Name EPOETIN ALFA - PRESERVATIVE FREE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103234 0 5 611989 40000 UML ( 40000 UML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name PROLIA
Proper Name DENOSUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 7 of 42
CDER Billable Biologic Product List
ApplicantLicense No AMGEN INC 1080
125320 0 1 612010 60 MGML ( 60 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name REPATHA
Proper Name EVOLOCUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125522 0 1 8272015 140 MGML ( 140 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125522 1 2 7112016 420 MG35 ML ( 120 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125522 0 3 8272015 140 MGML ( 140 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name VECTIBIX
Proper Name PANITUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125147 0 1 9272006 100 MG5 ML ( 20 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125147 0 2 9272006 200 MG10 ML ( 20 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125147 0 3 9272006 400 MG20 ML ( 20 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name XGEVA
Proper Name DENOSUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125320 7 2 11182010 120 MG17 ML ( 70 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 8 of 42
CDER Billable Biologic Product List
ApplicantLicense No ASTRAZENECA UK LTD 2043
Trade Name FASENRA
Proper Name BENRALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761070 0 1 11142017
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
30 MGML ( 30 MGML )
Trade Name
Proper Name
IMFINZI
DURVALUMAB
BLASTN
761069 0
Product
1
Approval Date
512017
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
120 MG24 ML ( 50 MGML )
761069 0 2 512017
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
500 MG10 ML ( 50 MGML )
ApplicantLicense No AUXILIUM PHARMACEUTICALS INC 1816
Trade Name XIAFLEX
Proper Name CLOSTRIDIAL COLLAGENASE HISTOLYTICUM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125338 0 1 222010 09 MG ( 09 MGVIAL )
POWDER INTRALESIONAL SINGLE-DOSE VIAL
ApplicantLicense No AYTU BIOSCIENCES INC 2035
Trade Name PROSTASCINT
Proper Name CAPROMAB PENDETIDE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103608 0 1 10281996 05 MGML ( 05 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 9 of 42
CDER Billable Biologic Product List
ApplicantLicense No BAXALTA US INC 2020
Trade Name ONCASPAR
Proper Name PEGASPARGASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103411 0 1 211994 3750 IU5 ML ( 750 IUML )
SOLUTION INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No BAYER HEALTHCARE PHARMACEUTICALS INC 1778
Trade Name BETASERON
Proper Name INTERFERON BETA-1B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103471 0 1 7231993 03 MG ( 03 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No BIOGEN INC 1697
Trade Name AVONEX
Proper Name INTERFERON BETA 1A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103628 0 1 5171996
POWDER INTRAMUSCULAR
30 MCG ( 30 MCGVIAL )
SINGLE-DOSE VIAL
103628 0 2 5171996
SOLUTION INTRAMUSCULAR PREFILLED SYRINGE
30 MCG05 ML ( 30 MCG05 ML )
103628 0 3 5171996
SOLUTION INTRAMUSCULAR AUTOINJECTOR
30 MCG05 ML ( 30 MCG05 ML )
Trade Name
Proper Name
BLASTN
125499 0
PLEGRIDY
PEGINTERFERON BETA-1A
Approval Date PotencyDosage FormRoutePresentation Product
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
63 MCG05 ML ( 126 MCGML ) 8152014 1
March 2018 Page 10 of 42
CDER Billable Biologic Product List
ApplicantLicense No BIOGEN INC 1697
125499 0 2 8152014 125 MCG05 ML ( 250 MCGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125499 0 3 8152014 63 MCG05 ML ( 126 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125499 0 4 8152014 94 MCG05 ML ( 188 MCGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125499 0 5 8152014 94 MCG05 ML ( 188 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125499 0 6 8152014 125 MCG05 ML ( 250 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name TYSABRI
Proper Name NATALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125104 0 1 11232004 300 MG15 ML ( 20 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name ZINBRYTA
Proper Name DACLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761029 0 1 5272016 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
761029 0 2 5272016 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 11 of 42
CDER Billable Biologic Product List
ApplicantLicense No BIOMARIN PHARMACEUTICAL INC 1649
Trade Name ALDURAZYME
Proper Name LARONIDASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125058 0 1 4302003
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
29 MG5 ML ( 058 MGML )
Trade Name
Proper Name
BRINEURA
CERLIPONASE ALFA
BLASTN
761052 0
Product
1
Approval Date
4272017
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENTRICULAR SINGLE-DOSE VIAL
150 MG5 ML ( 30 MGML )
Trade Name
Proper Name
NAGLAZYME
GALSULFASE
BLASTN
125117 0
Product
1
Approval Date
5312005
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
5 MG 5ML ( 1 MGML )
Trade Name
Proper Name
VIMIZIM
ELOSULFASE ALFA
BLASTN
125460 0
Product
1
Approval Date
2142014
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
5 MG5 ML ( 1 MGML )
ApplicantLicense No BOEHRINGER INGELHEIM PHARMACEUTICALS INC 2006
Trade Name PRAXBIND
Proper Name IDARUCIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761025 0 1 10162015 2500 MG50 ML ( 50 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 12 of 42
CDER Billable Biologic Product List
ApplicantLicense No BRISTOL MYERS SQUIBB CO 1713
Trade Name EMPLICITI
Proper Name ELOTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761035 0 1 11302015
POWDER INTRAVENOUS SINGLE-DOSE VIAL
300 MG ( 300 MGVIAL )
761035 0 2 11302015
POWDER INTRAVENOUS SINGLE-DOSE VIAL
400 MG ( 400 MGVIAL )
Trade Name
Proper Name
BLASTN
125288 0
NULOJIX
BELATACEPT
Approval Date Product
6152011 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
250 MG ( 250 MGVIAL )
Trade Name
Proper Name
BLASTN
125554 0
OPDIVO
NIVOLUMAB
Approval Date Product
12222014 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
40 MG4 ML ( 10 MGML )
125554 0 2 12222014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG10 ML ( 10 MGML )
125554 0 3 12222014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
240 MG24 ML ( 10 MGML )
Trade Name
Proper Name
BLASTN
125118 0
ORENCIA
ABATACEPT
Approval Date Product
12232005 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
250 MG ( 250 MGVIAL )
March 2018 Page 13 of 42
CDER Billable Biologic Product List
ApplicantLicense No BRISTOL MYERS SQUIBB CO 1713
125118 122 2 7292011 50 MG04 ML ( 125 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125118 122 3 7292011 875 MG07 ML ( 125 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125118 122 4 7292011 125 MGML ( 125 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125118 122 5 7292011 125 MGML ( 125 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name YERVOY
Proper Name IPILIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125377 0 1 3252011 50 MG10 ML ( 5 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125377 0 2 3252011 200 MG40 ML ( 5 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No BTG INTERNATIONAL INC 1861
Trade Name VORAXAZE
Proper Name GLUCARPIDASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125327 0 1 1172012 1000 U ( 1000 UVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 14 of 42
CDER Billable Biologic Product List
ApplicantLicense No DYAX CORPORATION 1789
Trade Name KALBITOR
Proper Name ECALLANTIDE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125277 0 1 1212009 10 MGML ( 10 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No EKR THERAPEUTICS INC 1814
Trade Name RETAVASE
Proper Name RETEPLASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103786 0 1 561998 10 U ( 10 UVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No ELI LILLY AND CO 1891
Trade Name CYRAMZA
Proper Name RAMUCIRUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125477 0 1 4212014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG10 ML ( 10 MGML )
125477 0 2 4212014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
500 MG50 ML ( 10 MGML )
Trade Name
Proper Name
BLASTN
761038 0
LARTRUVO
OLARATUMAB
Approval Date Product
10192016 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
500 MG50 ML ( 10 MGML )
761038 0 2 10192016
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
190 MG19 ML ( 10 MGML )
March 2018 Page 15 of 42
CDER Billable Biologic Product List
ApplicantLicense No ELI LILLY AND CO 1891
Trade Name PORTRAZZA
Proper Name NECITUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125547 0 1 11242015
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
800 MG50 ML ( 16 MGML )
Trade Name
Proper Name
TALTZ
IXEKIZUMAB
BLASTN
125521 0
Product
1
Approval Date
3222016
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
80 MGML ( 80 MGML )
125521 0 2 3222016
SOLUTION SUBCUTANEOUS AUTOINJECTOR
80 MGML ( 80 MGML )
Trade Name
Proper Name
TRULICITY
DULAGLUTIDE
BLASTN
125469 0
Product
1
Approval Date
9182014
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
075 MG05 ML ( 075 MG05 ML )
125469 0 2 9182014
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
15 MG05 ML ( 15 MG05 ML )
125469 0 3 9182014
SOLUTION SUBCUTANEOUS AUTOINJECTOR
075 MG05 ML ( 075 MG05 ML )
125469 0 4 9182014
SOLUTION SUBCUTANEOUS AUTOINJECTOR
15 MG05 ML ( 15 MG05 ML )
March 2018 Page 16 of 42
CDER Billable Biologic Product List
ApplicantLicense No ELUSYS THERAPEUTICS INC 1907
Trade Name ANTHIM
Proper Name OBILTOXAXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125509 1 1 3182016 600 MG6 ML ( 100 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No EMD SERONO INC 1773
Trade Name BAVENCIO
Proper Name AVELUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761049 0 1 3232017
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
200 MG10 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
103780 0
REBIF
INTERFERON BETA 1A
Approval Date Product
372002 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
88 MCG02 ML ( 44 MCGML )
103780 0 2 372002
SOLUTION SUBCUTANEOUS AUTOINJECTOR
88 MCG02 ML ( 44 MCGML )
103780 0 3 372002
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
22 MCG05 ML ( 44 MCGML )
103780 0 4 372002
SOLUTION SUBCUTANEOUS AUTOINJECTOR
22 MCG05 ML ( 44 MCGML )
103780 0 5 372002
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
44 MCG05 ML ( 88 MCGML )
103780 0 6 372002
SOLUTION SUBCUTANEOUS AUTOINJECTOR
44 MCG05 ML ( 88 MCGML )
March 2018 Page 17 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name ACTEMRA
Proper Name TOCILIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125276 0 1 182010
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
80 MG4 ML ( 20 MGML )
125276 0 2 182010
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
200 MG10 ML ( 20 MGML )
125276 0 3 182010
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
400 MG20 ML ( 20 MGML )
BLASTN
125472 1
Product
1
Approval Date
10212013
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
162 MG09 ML ( 179 MGML )
Trade Name
Proper Name
BLASTN
103172 0
ACTIVASE
ALTEPLASE
Approval Date Product
11131987 2
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
50 MG ( 50 MGVIAL )
103172 0 3 11131987
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
BLASTN
125085 0
AVASTIN
BEVACIZUMAB
Approval Date Product
2262004 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG4 ML ( 25 MGML )
125085 0 2 2262004
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
400 MG16 ML ( 25 MGML )
March 2018 Page 18 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name CATHFLO ACTIVASE
Proper Name ALTEPLASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103172 0 1 11131987
POWDER INTRACATHETER SINGLE-DOSE VIAL
2 MG ( 2 MGVIAL )
Trade Name
Proper Name
BLASTN
125486 0
GAZYVA
OBINUYUZUMAB
Approval Date Product
1112013 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1000 MG40 ML ( 25 MGML )
Trade Name
Proper Name
BLASTN
761083 0
HEMLIBRA
EMICIZUMAB-KXWH
Approval Date Product
11162017 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML )
761083 0 2 11162017
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
60 MG04 ML ( 150 MGML )
761083 0 3 11162017
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
105 MG07 ML ( 150 MGML )
761083 0 4 11162017
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
150 MGML ( 150 MGML )
Trade Name
Proper Name
BLASTN
103792 0
HERCEPTIN
TRASTUZUMAB
Approval Date Product
9251998 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS MULTI-DOSE VIAL
420 MG ( 420 MGVIAL )
March 2018 Page 19 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
103792 5336 2 2102017 150 MG ( 150 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name KADCYLA
Proper Name ADO-TRASIUZUMAB EMTANSINE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125427 0 1 2222013
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
125427 0 2 2222013
POWDER INTRAVENOUS SINGLE-DOSE VIAL
160 MG ( 160 MGVIAL )
Trade Name
Proper Name
LUCENTIS
RANIBIZUMAB
BLASTN
125156 0
Product
1
Approval Date
6302006
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE
05 MG005 ML ( 10 MGML )
Proper Name RANIDIZUMAB
BLASTN
125156 076
Product
2
Approval Date
8102012
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE
03 MG005 ML ( 6 MGML )
Trade Name
Proper Name
OCREVUS
OCRELIZUMAB
BLASTN
761053 0
Product
1
Approval Date
3282017
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
300 MG10 ML ( 30 MGML )
Trade Name
Proper Name
PERJETA
PERTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 20 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
125409 0 1 682012 420 MG14 ML ( 30 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name PULMOZYME
Proper Name DORNASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103532 0 1 12301993 25 MG25 ML ( 1 MGML )
SOLUTION INHALATION AMPULE
Trade Name RITUXAN
Proper Name RITUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103705 0 1 11261997 100 MG10 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
103705 0 2 11261997 500 MG50 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name RITUXAN HYCELA
Proper Name RITUXIMAB AND HYALURONIDASE HUMAN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761064 0 1 6222017 1400 MG AND 23400 U117 ML ( 11966 MG AND 2000 UML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
761064 0 2 6222017 1600 MG AND 26800 U134 ML ( 11966 MG AND 2000 UML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name TECENTRIQ
Proper Name ATEZOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761034 0 1 582016 1200 MG20 ML ( 60 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name TNKASE
March 2018 Page 21 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Proper Name TENECTEPLASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103909 0 1 622000 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103976 0 1 6202003 150 MG ( 150 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103948 0 1 572001
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML )
Trade Name
Proper Name
FABRAZYME
AGALSIDASE BETA
BLASTN
103979 0
Product
1
Approval Date
4242003
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
5 MG ( 5 MGVIAL )
103979 0 2 4242003
POWDER INTRAVENOUS SINGLE-DOSE VIAL
35 MG ( 35 MGVIAL )
Trade Name
Proper Name
LEMTRADA
ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 22 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENZYME CORP 1596
103948 5139 2 11142014 12 MG12 ML ( 10MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name LUMIZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125291 0 1 5242010 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name NUCALA
Proper Name MEPOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125526 0 1 11142015
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
TANZEUM
ALBIGLUTIDE
BLASTN
125431 0
Product
1
Approval Date
4152014
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS AUTOINJECTOR
30 MG ( 30 MGAUTOINJECTOR )
125431 0 2 4152014
POWDER SUBCUTANEOUS AUTOINJECTOR
50 MG ( 50 MGAUTOINJECTOR )
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name PEGASYS
Proper Name PEGINTERFERON ALFA 2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103964 5204 4 9292011 180 MCG05 ML ( 360 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 23 of 42
CDER Billable Biologic Product List
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Proper Name PEG-INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103964 0 1 10162002 180 MCGML ( 180 MCGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
103964 0 2 10162002 180 MCG05 ML ( 360 MCGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
103964 5204 3 9292011 135 MCG05 ML ( 270 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
ApplicantLicense No HORIZON PHARMA IRELAND LTD 2022
Trade Name ACTIMMUNE
Proper Name INTERFERON GAMMA-1B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103836 0 1 2251999 100 MCG05 ML ( 200 MCGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No HORIZON PHARMA RHEUMATOLOGY LLC 1998
Trade Name KRYSTEXXA
Proper Name PEGLOTICASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125293 0 1 9142010 8MGML ( 8MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 24 of 42
CDER Billable Biologic Product List
ApplicantLicense No HUMAN GENOME SCIENCES INC 1820
Trade Name BENLYSTA
Proper Name BELIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125370 0 1 392011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
120 MG ( 120 MGVIAL )
125370 0 2 392011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
400 MG ( 400 MGVIAL )
125370 0 3 392011
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )
125370 0 4 392011
SOLUTION SUBCUTANEOUS AUTOINJECTOR
200 MGML ( 200 MGML )
BLASTN
761043 0
Product
1
Approval Date
7202017
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )
Trade Name
Proper Name
RAXIBACUMAB
RAXIBACUMAB
BLASTN
125349 0
Product
1
Approval Date
12142012
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1700 MG34 ML ( 50 MGML )
ApplicantLicense No IMCLONE LLC 1695
Trade Name ERBITUX
Proper Name CETUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125084 0 1 2122004 100 MG50 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 25 of 42
CDER Billable Biologic Product List
ApplicantLicense No IMCLONE LLC 1695
125084 0 2 2122004 200 MG100 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No IMMUNEX CORP 1132
Trade Name ENBREL
Proper Name ETANERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103795 0 1 1121998
POWDER SUBCUTANEOUS MULTI-DOSE VIAL
25 MG ( 25 MGVIAL )
103795 5184 2 9272004
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
50 MGML ( 50 MGML )
103795 0 3 9272004
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MGML ( 50 MGML )
103795 5184 4 9272004
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
25 MG05 ML ( 50 MGML )
103795 5556 5 9142017
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MGML ( 50 MGML )
ApplicantLicense No IPSEN BIOPHARM LIMITED 1787
Trade Name DYSPORT
Proper Name ABOBOTULINUMTOXINA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125274 0 1 4292009
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
300 UNITS ( 300 UNITSVIAL )
125274 0 2 4292009
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
500 UNITS ( 500 UNITSVIAL )
March 2018 Page 26 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
Trade Name DARZALEX
Proper Name DARATUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761036 0 1 11162015
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG5 ML ( 20 MGML )
761036 0 2 11162015
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
400 MG20 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
103772 0
REMICADE
INFLIXIMAB
Approval Date Product
8241998 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
BLASTN
103575 0
REOPRO
ABCIXIMAB
Approval Date Product
12221994 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
10 MG5 ML ( 2 MGML )
Trade Name
Proper Name
BLASTN
125289 0
SIMPONI
GOLIMUMAB
Approval Date Product
4242009 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
50 MG05 ML ( 100 MGML )
125289 0 2 4242009
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MG05 ML ( 100 MGML )
125289 0 3 4242009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
100 MGML ( 100 MGML )
March 2018 Page 27 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
125289 0 4 4242009 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name SIMPONI ARIA
Proper Name GOLIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125433 0 1 7182013 50 MG4 ML ( 125 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name STELARA
Proper Name USTEKINUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125261 0 1 9252009 90 MGML ( 90 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125261 0 2 9252009 45 MG05 ML ( 90 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL amp PREFILLED SYRINGE
125261 0 3 9252009 130 MG26 ML ( 5 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761044 0 1 9232016 130 MG26 ML ( 5 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SYLVANT
Proper Name SILTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125496 0 1 4232014 100 MG ( 100 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125496 0 2 4232014 400 MG ( 400 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 28 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
Trade Name TREMFYA
Proper Name GUSELKUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761061 0 1 7132017 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No JAZZ PHARMACEUTICALS INC 1901
Trade Name ERWINAZE
Proper Name ASPARAGINASE ERWINIA CHRYSANTHEMI
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
105359 0 1 11182011 10000 IU ( 10000 IUVIAL )
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103770 0 1 6191998
SOLUTION INTRAMUSCULAR
50 MG05 ML ( 100 MGML )
SINGLE-DOSE VIAL
103770 0 2 6191998
SOLUTION INTRAMUSCULAR
100 MGML ( 100 MGML )
SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name ILUMYA
Proper Name TILDRAKIZUMAB-ASMN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761067 0 1 3202018 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name INTRON A
March 2018 Page 29 of 42
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103132 0 1 641986 10 MIU ( 10 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL INTRAVENOUS SINGLE-DOSE VIAL
103132 0 2 641986 18 MIU ( 18 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL
103132 0 3 641986 50 MIU ( 50 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL
103132 0 4 641986 228 MIU38 ML ( 6 MIUML )
SOLUTION INTRAMUSCULAR SUBCUTANEOUS MULTI-DOSE VIAL
103132 0 5 641986 32 MIU32 ML ( 10 MIUML )
SOLUTION INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL MULTI-DOSE VIAL
Trade Name KEYTRUDA
Proper Name PEMBROLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125514 0 1 942014 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125514 1 2 1152015 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 0 1 1192001 74 MCG ( 74 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SYLATRON
Proper Name PEGINTERFERON ALFA-2B
March 2018 Page 30 of 42
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 5153 2 3292011 296 MCG ( 296 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 3 3292011 444 MCG ( 444 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 4 3292011 888 MCG ( 888 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name ZINPLAVA
Proper Name BEZLOTOXUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761046 0 1 10212016 1000 MG40 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No MERZ PHARMACEUTICALS GMBH 1830
Trade Name XEOMIN
Proper Name INCOBOTULINUMTOXINA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125360 0 1 7302010
POWDER INTRAMUSCULAR
50 U ( 50 UVIAL )
SINGLE-DOSE VIAL
125360 0 2 7302010
POWDER INTRAMUSCULAR
100 U ( 100 UVIAL )
SINGLE-DOSE VIAL
125360 3 3 11202015
POWDER INTRAMUSCULAR
200 U ( 200 UVIAL )
SINGLE-DOSE VIAL
March 2018 Page 31 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
Trade Name ARZERRA
Proper Name OFATUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125326 0 1 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG5 ML ( 20 MGML )
125326 0 2 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1000 MG50 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
125504 0
COSENTYX
SECUKINUMAB
Approval Date Product
1212015 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
150 MG ( 150 MGVIAL )
125504 0 2 1212015
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MGML ( 150 MGML )
125504 0 3 1212015
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MGML ( 150 MGML )
Trade Name
Proper Name
BLASTN
125290 0
EXTAVIA
INTERFERON BETA-1B
Approval Date Product
8142009 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
03 MG ( 03 MGVIAL )
Trade Name
Proper Name
BLASTN
125319 0
ILARIS
CANAKINUMAB
Approval Date Product
6172009 1
PotencyDosage FormRoutePresentation
180 MGVIAL ( 180 MGVIAL )
March 2018 Page 32 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
125319 88 2 12222016 150 MG ( 150 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
125319 0 3 12222016 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SIMULECT
Proper Name BASILIXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103764 0 1 5121998 10 MG ( 10 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
103764 0 2 5121998 20 MG ( 20 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No NPS PHARMACEUTICALS INC 1908
Trade Name NATPARA
Proper Name PARATHYROID HORMONE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 33 of 42
CDER Billable Biologic Product List
ApplicantLicense No PROMETHEUS LABORATORIES INC 1848
Trade Name PROLEUKIN
Proper Name ALDESLEUKIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103293 0 1 551992 22 MIU ( 22 MIUVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760
Trade Name ARCALYST
Proper Name RILONACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125249 0 1 2272008
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
220MG ( 220MGVIAL )
Trade Name
Proper Name
DUPIXENT
DUPILUMAB
BLASTN
761055 0
Product
1
Approval Date
3282017
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
300 MG2 ML ( 150 MGML )
Trade Name
Proper Name
EYLEA
AFLIBERCEPT
BLASTN
125387 0
Product
1
Approval Date
11182011
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
2 MG005 ML ( 40 MGML )
March 2018 Page 34 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Trade Name ELITEK
Proper Name RASBURICASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103946 0 1 7122002
POWDER INTRAVENOUS SINGLE-DOSE VIAL
15 MG ( 15 MGVIAL )
103946 5020 2 162006
POWDER INTRAVENOUS SINGLE-DOSE VIAL
75 MG ( 75 MGVIAL )
Trade Name
Proper Name
BLASTN
761037 0
KEVZARA
SARILUMAB
Approval Date Product
5222017 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MG114 ML ( 13158 MGML )
761037 0 2 5222017
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MG114 ML ( 17544 MGML )
761037 1 3 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MG114 ML ( 13158 MGML )
761037 1 4 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
200 MG114 ML ( 17544 MGML )
Trade Name
Proper Name
BLASTN
103362 0
LEUKINE
SARGRAMOSTIM
Approval Date Product
351991 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
250 MCG ( 250 MCGVIAL )
103362 0 2 351991
SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL
500 MCGML ( 500 MCGML )
Trade Name PRALUENT
March 2018 Page 35 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Proper Name ALIROCUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125559 0 1 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 2 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 3 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125559 0 4 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name ZALTRAP
Proper Name ZIV-AFLIBERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125418 0 1 832012 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125418 0 2 832012 200 MG8 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SEATTLE GENETICS INC 1853
Trade Name ADCETRIS
Proper Name BRENTUXIMAB VEDOTIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125388 1 1 8192011 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 36 of 42
CDER Billable Biologic Product List
ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593
Trade Name ELAPRASE
Proper Name IDURSULFASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125151 0 1 7242006 6 MG3 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SICOR BIOTECH UAB 1803
Trade Name GRANIX
Proper Name TBO-FILGRASTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125294 0 1 8292012
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
300 MCG0 5 ML ( 600 MCGML )
125294 0 2 8292012
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
480 MCG08 ML ( 600 MCGML )
ApplicantLicense No SMITH AND NEPHEW INC 2004
Trade Name REGRANEX
Proper Name BECAPLERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103691 0 1 12161997
GEL TOPICAL
100 UG ( 100 UGGM )
Trade Name
Proper Name
SANTYL
COLLAGENASE
BLASTN
101995 0
Product
1
Approval Date
641965
PotencyDosage FormRoutePresentation
OINTMENT TOPICAL
30 G amp 90 G TUBE ( 250 UGRAM )
March 2018 Page 37 of 42
CDER Billable Biologic Product List
ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718
Trade Name MYOBLOC
Proper Name RIMABOTULINUM TOXIN B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103846 0 1 1282002
SOLUTION INTRAMUSCULAR
2500 IU05 ML ( 5000 IUML )
SINGLE-DOSE VIAL
103846 0 3 1282002
SOLUTION INTRAMUSCULAR
10000 IU2 ML ( 5000 IUML )
SINGLE-DOSE VIAL
Proper Name RIMABOTULINUMTOXINB
BLASTN
103846 0
Product
2
Approval Date
1282002
PotencyDosage FormRoutePresentation
SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL
5000 IUML ( 5000 IUML )
ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832
Trade Name ZEVALIN
Proper Name IBRITUMOMAB TIUXETAN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125019 0 1 2192002 32 MG2 ML ( 16 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
Trade Name KEPIVANCE
Proper Name PALIFERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125103 0 1 12152004 625 MG ( 625 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name KINERET
Proper Name ANAKINRA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 38 of 42
CDER Billable Biologic Product List
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898
Trade Name ENTYVIO
Proper Name VEDOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125476 0 1 5202014 300 MG ( 300 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No TEVA RESPIRATORY LLC 2047
Trade Name CINQAIR
Proper Name RESLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761033 0 1 3232016 100 MG10 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No THERATECHNOLOGIES INC 2091
Trade Name TROGARZO
Proper Name IBALIZUMAB-UIYK
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761065 0 1 362018 200 MG133 ML ( 150 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 39 of 42
CDER Billable Biologic Product List
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
0375 MG03 ML ( 125 MGML )2222017 125422 038 1
ApplicantLicense No UCB INC 1736
Trade Name CIMZIA
Proper Name CERTOLIZUMAB PEGOL
BLASTN Approval Date PotencyDosage FormRoutePresentation Product
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
200 MG ( 200 MGVIAL ) 4222008 125160 0 1
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )5132009 125160 080 2
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
Trade Name CRYSVITA
Proper Name BUROSUMAB-TWZA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761068 0 1 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
10 MGML ( 10 MGML )
761068 0 2 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
20 MGML ( 20 MGML )
761068 0
Trade Name
Proper Name
BLASTN
March 2018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML ) 4172018 3
MEPSEVII
VESTRONIDASE ALFA-VJBK
Approval Date PotencyDosage FormRoutePresentation Product
Page 40 of 42
CDER Billable Biologic Product List
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
761047 0 1 11152017 10 MG5 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No UNITED THERAPEUTICS CORP 1993
Trade Name UNITUXIN
Proper Name DINUTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125516 0 1 3102015 175 MG5 ML ( 35 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053
Trade Name SILIQ
Proper Name BRODALUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761032 0 1 2152017 210 MG15 ML ( 140 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 41 of 42
CDER Billable Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No WYETH PHARMACEUTICALS INC 0003
Trade Name BESPONSA
Proper Name INOTUZUMAB OZOGAMICIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761040 0 1 8172017 09 MG ( 09 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 42 of 42
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 1 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
9172001 103951 0 26
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
200 MCGML ( 200 MCGML ) 09272012
103951 0 27 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
200 MCG04 ML ( 500 MCGML ) 09272012
103951 0 28 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
300 MCGML ( 300 MCGML ) 09272012
103951 0 29 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
300 MCG06 ML ( 500 MCGML ) 09272012
103951 0 30 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
500 MCGML ( 500 MCGML ) 09272012
ApplicantLicense No ASTELLAS PHARMACEUTICALS US INC 1748
Trade Name AMEVIVE
Proper Name ALEFACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125036 0 1 1302003 75 MGVIAL ( 75 MGVIAL ) 09242008
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
125036 0 2 1302003 15 MGVIAL ( 15 MGVIAL ) 09282012
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No BOEHRINGER INGELHEIM PHARMA KG 1251
Trade Name VERLUMA
Proper Name NOFETUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103769 0 1 10131998 10 MGML ( 10 MGML ) 08132013
INTRAVENOUS
March 2018 Page 2 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No CENTOCOR ORTHO BIOTECH PRODUCTS LP 1824
Trade Name ORTHOCLONE OKT3
Proper Name MUROMONAB-CD3
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103463 0 1 9141992 1 MGML ( 1 MGML ) 01112012
SOLUTION INTRAVENOUS AMPULE
ApplicantLicense No EISAI INCORPORATED 1862
Trade Name ONTAK
Proper Name DENILEUKIN DIFTITOX
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103767 0 1 251999 300 MCG2 ML ( 150 MCGML ) 01302014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No ELI LILLY AND CO 1611
Trade Name XIGRIS
Proper Name DROTRECOGIN ALFA (ACTIVATED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125029 0 1 11212001 5 MGVIAL ( 5 MGVIAL ) 10262011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125029 0 2 11212001 20 MGVIAL ( 20 MGVIAL ) 10102011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GENENTECH INC 1048
Trade Name RAPTIVA
Proper Name EFALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125075 0 1 10272003 125 MGVIAL ( 125 MGVIAL ) 09012009
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
March 2018 Page 3 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103976 0 2 6202003 125 MGVIAL ( 125 MGVIAL ) 08252016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103948 0 3 572001 10 MGVIAL ( 10 MGVIAL ) 07062011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name MYOZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125141 0 1 4282006 50 MGVIAL ( 50 MGVIAL ) 10172014
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name BEXXAR THERAPEUTIC REGIME
Proper Name TOSITUMOMAB AND IODINE I-131 TOSITUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125011 0 1 6272003 01 MGML I-131 TOSITUMOMAB ( 01 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 2 6272003 11 MGML I-131 TOSITUMOMAB ( 11 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 3 6272003 14 MGML TOSITUMOMAB ( 14 MGML 03102014 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 4 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No HEMISPHERX BIOPHARMA INC 1703
Trade Name ALFERON N INJECTION
Proper Name INTERFERON ALFA-N3 (HUMAN LEUKOCYTE DERIVED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103158 0 1 10101989 5 MIUVIAL ( 5 MIUVIAL ) 06272013
SOLUTION INTRALESIONAL MULTI-DOSE VIAL
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name ROFERON A
Proper Name INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103145 0 1 641986 3 MIU05 ML ( 3 MIU05 ML ) 06012009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name ZENAPAX
Proper Name DACLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103749 0 1 12101997 25 MG5 ML ( 25 MG5 ML ) 07072011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No KADMON PHARMACEUTICALS LLC 1867
Trade Name INFERGEN
Proper Name INTERFERON ALFACON-1
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103663 0 1 1061997 9 MCG03 ML ( 30 MCGML ) 07252013
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 5 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103770 0 3 6191998 50 MGVIAL ( 50 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
103770 0 4 6191998 100 MGVIAL ( 100 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name INTRON A
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103132 0 6 641986 10 MIUML ( 10 MIUML ) 09232013
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103132 0 7 641986 225 MIU15 ML ( 225 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 8 641986 375 MIU15 ML ( 375 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 9 641986 75 MIU15 ML ( 75 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103949 0 5 1192001 675 MCGPEN ( 675 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 6 1192001 108 MCGPEN ( 108 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
March 2018 Page 6 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name PEGINTRON
103949 0 7 1192001 1184 MCGVIAL ( 1184 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 8 1192001 162 MCGPEN ( 162 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 9 1192001 1776 MCGVIAL ( 1776 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 10 1192001 2025 MCGPEN ( 2025 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 11 1192001 222 MCGVIAL ( 222 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No PALATIN TECHNOLOGIES INC 1588
Trade Name NEUTROSPEC TECHNETIUM (99M TC)
Proper Name FANOLESOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103928 0 1 722004 025 MGVIAL ( 025 MGVIAL ) 09222008
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No RECORDATI RARE DISEASES INC 1899
Trade Name ELSPAR
Proper Name ASPARAGINASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
101063 0 1 1101978 10000 IU ( 10000 IUVIAL ) 04092014
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
March 2018 Page 7 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No SCHERING CORP 0994
Trade Name PEGINTRONREBETOL COMBO PACK
Proper Name PEGINTERFERON ALFA-2B AND RIBAVIRIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125196 0 1 6132008 ( 4 (120 MCG05ML) REDIPEN amp 140 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 2 6132008 ( 4 (150 MCG05ML) REDIPEN amp 168 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 3 6132008 ( 4 (150 MCG05ML) REDIPEN amp 196 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 4 6132008 ( 4 (50 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 5 6132008 ( 4 (80 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125422 0 2 10172012 05 MG ( 25 MGML ) 08082017
SOLUTION INTRAVETREAL SINGLE-DOSE VIAL
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125164 0 10 11142007 50 MCGML ( 50 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 8 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
125164 0 11 11142007 100 MCGML ( 100 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 12 11142007 200 MCGML ( 200 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 13 11142007 300 MCGML ( 300 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 14 11142007 400 MCGML ( 400 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 15 11142007 400 MCG06 ML ( 400 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 16 11142007 600 MCGML ( 600 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 17 11142007 600 MCG06 ML ( 600 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 18 11142007 800 MCG06 ML ( 800 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 19 11142007 1000 MCGML ( 1000 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 9 of 9
CDER Billable Biologic Product List
ApplicantLicense No ALEXION PHARMACEUTICALS INC 1743
Proper Name ECULIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125166 0 1 3162007 10 MGML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name STRENSIQ
Proper Name ASFOTASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125513 0 1 10232015 18 MG045 ML ( 40 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
125513 0 2 10232015 80 MG08 ML ( 100 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
125513 0 3 10232015 28 MG07 ML ( 40 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
125513 0 4 10232015 40 MGML ( 40 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No ALLERGAN INC 1145
Trade Name BOTOX
Proper Name BOTULINUM TOXIN TYPE A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103000 0 1 1291991 100 U ( 100 UVIAL )
POWDER INTRAMUSCULAR INTRADERMAL INTRADETRUSOR SINGLE-DOSE VIAL
103000 5101 3 4142005 50 U ( 50 UVIAL )
POWDER INTRAMUSCULAR INTRADERMAL INTRADETRUSOR SINGLE-DOSE VIAL
103000 5122 5 11102005 200 U ( 200 UVIAL )
POWDER INTRAMUSCULAR INTRADERMAL INTRADETRUSOR SINGLE-DOSE VIAL
Trade Name BOTOX COSMETIC
March 2018 Page 3 of 42
CDER Billable Biologic Product List
ApplicantLicense No ALLERGAN INC 1145
Proper Name BOTULINUM TOXIN TYPE A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103000 5000 2 4122002 100 U ( 100 UVIAL )
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
103000 5101 4 4142005 50 U ( 50 UVIAL )
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
Proper Name DARBEPOETIN ALFA IN POLYSORBATE SOLUTION
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103951 0 1 9172001 25 MCGML ( 25 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 2 9172001 40 MCGML ( 40 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 3 9172001 60 MCGML ( 60 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 4 9172001 100 MCGML ( 100 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 5 9172001 150 MCG075 ML ( 150 MCG075 ML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 6 9172001 200 MCGML ( 200 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 7 9172001 300 MCGML ( 300 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 4 of 42
CDER Billable Biologic Product List
ApplicantLicense No AMGEN INC 1080
103951 0 8 9172001 25 MCG042 ML ( 25 MCG042 ML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 9 9172001 40 MCG04 ML ( 40 MCG04 ML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 10 9172001 60 MCG03 ML ( 60 MCG03 ML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 11 9172001 100 MCG05 ML ( 100 MCG05 ML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 12 9172001 150 MCG03 ML ( 150 MCG03 ML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 13 9172001 200 MCG04 ML ( 200 MCG04 ML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 14 9172001 300 MCG06 ML ( 300 MCG06 ML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 15 9172001 500 MCGML ( 500 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 31 9172001 10 MCG04 ML ( 10 MCG04 ML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
Trade Name BLINCYTO
Proper Name BLINATUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125557 0 1 1232014 35 MCG ( 35 MCGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name EPOGEN
Proper Name EPOETIN ALFA
March 2018 Page 5 of 42
CDER Billable Biologic Product List
ApplicantLicense No AMGEN INC 1080
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103234 0 6 611989 10000 UML ( 10000 UML )
SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL
103234 0 7 611989 20000 UML ( 10000 UML )
SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL
Proper Name EPOETIN ALFA - PRESERVATIVE FREE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103234 0 1 611989 2000 UML ( 2000 UML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103234 0 2 611989 3000 UML ( 3000 UML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103234 0 3 611989 4000 UML ( 4000 UML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103234 0 4 611989 10000 UML ( 10000 UML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name NEULASTA
Proper Name PEGFILGRASTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125031 0 1 1312002 6 MG06 ML ( 10 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name NEULASTA ONPRO
Proper Name PEGFILGRASTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125031 181 2 9232015 6 MG06 ML ( 10 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name NEUPOGEN
March 2018 Page 6 of 42
CDER Billable Biologic Product List
ApplicantLicense No AMGEN INC 1080
Proper Name FILGRASTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103353 0 1 2201991 300 MCGML ( 300 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103353 0 2 2201991 300 MCG05 ML ( 600 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103353 0 3 2201991 480 MCG16 ML ( 300 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103353 0 4 2201991 480 MCG08 ML ( 600 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
Trade Name NPLATE
Proper Name ROMIPLOSTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125268 0 1 8222008 250 MCG ( 250 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
125268 0 2 8222008 500 MCG ( 500 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name PROCRIT
Proper Name EPOETIN ALFA - PRESERVATIVE FREE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103234 0 5 611989 40000 UML ( 40000 UML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name PROLIA
Proper Name DENOSUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 7 of 42
CDER Billable Biologic Product List
ApplicantLicense No AMGEN INC 1080
125320 0 1 612010 60 MGML ( 60 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name REPATHA
Proper Name EVOLOCUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125522 0 1 8272015 140 MGML ( 140 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125522 1 2 7112016 420 MG35 ML ( 120 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125522 0 3 8272015 140 MGML ( 140 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name VECTIBIX
Proper Name PANITUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125147 0 1 9272006 100 MG5 ML ( 20 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125147 0 2 9272006 200 MG10 ML ( 20 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125147 0 3 9272006 400 MG20 ML ( 20 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name XGEVA
Proper Name DENOSUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125320 7 2 11182010 120 MG17 ML ( 70 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 8 of 42
CDER Billable Biologic Product List
ApplicantLicense No ASTRAZENECA UK LTD 2043
Trade Name FASENRA
Proper Name BENRALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761070 0 1 11142017
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
30 MGML ( 30 MGML )
Trade Name
Proper Name
IMFINZI
DURVALUMAB
BLASTN
761069 0
Product
1
Approval Date
512017
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
120 MG24 ML ( 50 MGML )
761069 0 2 512017
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
500 MG10 ML ( 50 MGML )
ApplicantLicense No AUXILIUM PHARMACEUTICALS INC 1816
Trade Name XIAFLEX
Proper Name CLOSTRIDIAL COLLAGENASE HISTOLYTICUM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125338 0 1 222010 09 MG ( 09 MGVIAL )
POWDER INTRALESIONAL SINGLE-DOSE VIAL
ApplicantLicense No AYTU BIOSCIENCES INC 2035
Trade Name PROSTASCINT
Proper Name CAPROMAB PENDETIDE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103608 0 1 10281996 05 MGML ( 05 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 9 of 42
CDER Billable Biologic Product List
ApplicantLicense No BAXALTA US INC 2020
Trade Name ONCASPAR
Proper Name PEGASPARGASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103411 0 1 211994 3750 IU5 ML ( 750 IUML )
SOLUTION INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No BAYER HEALTHCARE PHARMACEUTICALS INC 1778
Trade Name BETASERON
Proper Name INTERFERON BETA-1B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103471 0 1 7231993 03 MG ( 03 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No BIOGEN INC 1697
Trade Name AVONEX
Proper Name INTERFERON BETA 1A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103628 0 1 5171996
POWDER INTRAMUSCULAR
30 MCG ( 30 MCGVIAL )
SINGLE-DOSE VIAL
103628 0 2 5171996
SOLUTION INTRAMUSCULAR PREFILLED SYRINGE
30 MCG05 ML ( 30 MCG05 ML )
103628 0 3 5171996
SOLUTION INTRAMUSCULAR AUTOINJECTOR
30 MCG05 ML ( 30 MCG05 ML )
Trade Name
Proper Name
BLASTN
125499 0
PLEGRIDY
PEGINTERFERON BETA-1A
Approval Date PotencyDosage FormRoutePresentation Product
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
63 MCG05 ML ( 126 MCGML ) 8152014 1
March 2018 Page 10 of 42
CDER Billable Biologic Product List
ApplicantLicense No BIOGEN INC 1697
125499 0 2 8152014 125 MCG05 ML ( 250 MCGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125499 0 3 8152014 63 MCG05 ML ( 126 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125499 0 4 8152014 94 MCG05 ML ( 188 MCGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125499 0 5 8152014 94 MCG05 ML ( 188 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125499 0 6 8152014 125 MCG05 ML ( 250 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name TYSABRI
Proper Name NATALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125104 0 1 11232004 300 MG15 ML ( 20 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name ZINBRYTA
Proper Name DACLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761029 0 1 5272016 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
761029 0 2 5272016 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 11 of 42
CDER Billable Biologic Product List
ApplicantLicense No BIOMARIN PHARMACEUTICAL INC 1649
Trade Name ALDURAZYME
Proper Name LARONIDASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125058 0 1 4302003
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
29 MG5 ML ( 058 MGML )
Trade Name
Proper Name
BRINEURA
CERLIPONASE ALFA
BLASTN
761052 0
Product
1
Approval Date
4272017
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENTRICULAR SINGLE-DOSE VIAL
150 MG5 ML ( 30 MGML )
Trade Name
Proper Name
NAGLAZYME
GALSULFASE
BLASTN
125117 0
Product
1
Approval Date
5312005
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
5 MG 5ML ( 1 MGML )
Trade Name
Proper Name
VIMIZIM
ELOSULFASE ALFA
BLASTN
125460 0
Product
1
Approval Date
2142014
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
5 MG5 ML ( 1 MGML )
ApplicantLicense No BOEHRINGER INGELHEIM PHARMACEUTICALS INC 2006
Trade Name PRAXBIND
Proper Name IDARUCIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761025 0 1 10162015 2500 MG50 ML ( 50 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 12 of 42
CDER Billable Biologic Product List
ApplicantLicense No BRISTOL MYERS SQUIBB CO 1713
Trade Name EMPLICITI
Proper Name ELOTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761035 0 1 11302015
POWDER INTRAVENOUS SINGLE-DOSE VIAL
300 MG ( 300 MGVIAL )
761035 0 2 11302015
POWDER INTRAVENOUS SINGLE-DOSE VIAL
400 MG ( 400 MGVIAL )
Trade Name
Proper Name
BLASTN
125288 0
NULOJIX
BELATACEPT
Approval Date Product
6152011 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
250 MG ( 250 MGVIAL )
Trade Name
Proper Name
BLASTN
125554 0
OPDIVO
NIVOLUMAB
Approval Date Product
12222014 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
40 MG4 ML ( 10 MGML )
125554 0 2 12222014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG10 ML ( 10 MGML )
125554 0 3 12222014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
240 MG24 ML ( 10 MGML )
Trade Name
Proper Name
BLASTN
125118 0
ORENCIA
ABATACEPT
Approval Date Product
12232005 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
250 MG ( 250 MGVIAL )
March 2018 Page 13 of 42
CDER Billable Biologic Product List
ApplicantLicense No BRISTOL MYERS SQUIBB CO 1713
125118 122 2 7292011 50 MG04 ML ( 125 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125118 122 3 7292011 875 MG07 ML ( 125 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125118 122 4 7292011 125 MGML ( 125 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125118 122 5 7292011 125 MGML ( 125 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name YERVOY
Proper Name IPILIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125377 0 1 3252011 50 MG10 ML ( 5 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125377 0 2 3252011 200 MG40 ML ( 5 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No BTG INTERNATIONAL INC 1861
Trade Name VORAXAZE
Proper Name GLUCARPIDASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125327 0 1 1172012 1000 U ( 1000 UVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 14 of 42
CDER Billable Biologic Product List
ApplicantLicense No DYAX CORPORATION 1789
Trade Name KALBITOR
Proper Name ECALLANTIDE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125277 0 1 1212009 10 MGML ( 10 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No EKR THERAPEUTICS INC 1814
Trade Name RETAVASE
Proper Name RETEPLASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103786 0 1 561998 10 U ( 10 UVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No ELI LILLY AND CO 1891
Trade Name CYRAMZA
Proper Name RAMUCIRUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125477 0 1 4212014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG10 ML ( 10 MGML )
125477 0 2 4212014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
500 MG50 ML ( 10 MGML )
Trade Name
Proper Name
BLASTN
761038 0
LARTRUVO
OLARATUMAB
Approval Date Product
10192016 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
500 MG50 ML ( 10 MGML )
761038 0 2 10192016
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
190 MG19 ML ( 10 MGML )
March 2018 Page 15 of 42
CDER Billable Biologic Product List
ApplicantLicense No ELI LILLY AND CO 1891
Trade Name PORTRAZZA
Proper Name NECITUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125547 0 1 11242015
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
800 MG50 ML ( 16 MGML )
Trade Name
Proper Name
TALTZ
IXEKIZUMAB
BLASTN
125521 0
Product
1
Approval Date
3222016
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
80 MGML ( 80 MGML )
125521 0 2 3222016
SOLUTION SUBCUTANEOUS AUTOINJECTOR
80 MGML ( 80 MGML )
Trade Name
Proper Name
TRULICITY
DULAGLUTIDE
BLASTN
125469 0
Product
1
Approval Date
9182014
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
075 MG05 ML ( 075 MG05 ML )
125469 0 2 9182014
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
15 MG05 ML ( 15 MG05 ML )
125469 0 3 9182014
SOLUTION SUBCUTANEOUS AUTOINJECTOR
075 MG05 ML ( 075 MG05 ML )
125469 0 4 9182014
SOLUTION SUBCUTANEOUS AUTOINJECTOR
15 MG05 ML ( 15 MG05 ML )
March 2018 Page 16 of 42
CDER Billable Biologic Product List
ApplicantLicense No ELUSYS THERAPEUTICS INC 1907
Trade Name ANTHIM
Proper Name OBILTOXAXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125509 1 1 3182016 600 MG6 ML ( 100 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No EMD SERONO INC 1773
Trade Name BAVENCIO
Proper Name AVELUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761049 0 1 3232017
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
200 MG10 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
103780 0
REBIF
INTERFERON BETA 1A
Approval Date Product
372002 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
88 MCG02 ML ( 44 MCGML )
103780 0 2 372002
SOLUTION SUBCUTANEOUS AUTOINJECTOR
88 MCG02 ML ( 44 MCGML )
103780 0 3 372002
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
22 MCG05 ML ( 44 MCGML )
103780 0 4 372002
SOLUTION SUBCUTANEOUS AUTOINJECTOR
22 MCG05 ML ( 44 MCGML )
103780 0 5 372002
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
44 MCG05 ML ( 88 MCGML )
103780 0 6 372002
SOLUTION SUBCUTANEOUS AUTOINJECTOR
44 MCG05 ML ( 88 MCGML )
March 2018 Page 17 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name ACTEMRA
Proper Name TOCILIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125276 0 1 182010
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
80 MG4 ML ( 20 MGML )
125276 0 2 182010
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
200 MG10 ML ( 20 MGML )
125276 0 3 182010
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
400 MG20 ML ( 20 MGML )
BLASTN
125472 1
Product
1
Approval Date
10212013
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
162 MG09 ML ( 179 MGML )
Trade Name
Proper Name
BLASTN
103172 0
ACTIVASE
ALTEPLASE
Approval Date Product
11131987 2
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
50 MG ( 50 MGVIAL )
103172 0 3 11131987
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
BLASTN
125085 0
AVASTIN
BEVACIZUMAB
Approval Date Product
2262004 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG4 ML ( 25 MGML )
125085 0 2 2262004
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
400 MG16 ML ( 25 MGML )
March 2018 Page 18 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name CATHFLO ACTIVASE
Proper Name ALTEPLASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103172 0 1 11131987
POWDER INTRACATHETER SINGLE-DOSE VIAL
2 MG ( 2 MGVIAL )
Trade Name
Proper Name
BLASTN
125486 0
GAZYVA
OBINUYUZUMAB
Approval Date Product
1112013 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1000 MG40 ML ( 25 MGML )
Trade Name
Proper Name
BLASTN
761083 0
HEMLIBRA
EMICIZUMAB-KXWH
Approval Date Product
11162017 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML )
761083 0 2 11162017
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
60 MG04 ML ( 150 MGML )
761083 0 3 11162017
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
105 MG07 ML ( 150 MGML )
761083 0 4 11162017
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
150 MGML ( 150 MGML )
Trade Name
Proper Name
BLASTN
103792 0
HERCEPTIN
TRASTUZUMAB
Approval Date Product
9251998 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS MULTI-DOSE VIAL
420 MG ( 420 MGVIAL )
March 2018 Page 19 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
103792 5336 2 2102017 150 MG ( 150 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name KADCYLA
Proper Name ADO-TRASIUZUMAB EMTANSINE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125427 0 1 2222013
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
125427 0 2 2222013
POWDER INTRAVENOUS SINGLE-DOSE VIAL
160 MG ( 160 MGVIAL )
Trade Name
Proper Name
LUCENTIS
RANIBIZUMAB
BLASTN
125156 0
Product
1
Approval Date
6302006
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE
05 MG005 ML ( 10 MGML )
Proper Name RANIDIZUMAB
BLASTN
125156 076
Product
2
Approval Date
8102012
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE
03 MG005 ML ( 6 MGML )
Trade Name
Proper Name
OCREVUS
OCRELIZUMAB
BLASTN
761053 0
Product
1
Approval Date
3282017
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
300 MG10 ML ( 30 MGML )
Trade Name
Proper Name
PERJETA
PERTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 20 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
125409 0 1 682012 420 MG14 ML ( 30 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name PULMOZYME
Proper Name DORNASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103532 0 1 12301993 25 MG25 ML ( 1 MGML )
SOLUTION INHALATION AMPULE
Trade Name RITUXAN
Proper Name RITUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103705 0 1 11261997 100 MG10 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
103705 0 2 11261997 500 MG50 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name RITUXAN HYCELA
Proper Name RITUXIMAB AND HYALURONIDASE HUMAN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761064 0 1 6222017 1400 MG AND 23400 U117 ML ( 11966 MG AND 2000 UML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
761064 0 2 6222017 1600 MG AND 26800 U134 ML ( 11966 MG AND 2000 UML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name TECENTRIQ
Proper Name ATEZOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761034 0 1 582016 1200 MG20 ML ( 60 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name TNKASE
March 2018 Page 21 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Proper Name TENECTEPLASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103909 0 1 622000 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103976 0 1 6202003 150 MG ( 150 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103948 0 1 572001
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML )
Trade Name
Proper Name
FABRAZYME
AGALSIDASE BETA
BLASTN
103979 0
Product
1
Approval Date
4242003
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
5 MG ( 5 MGVIAL )
103979 0 2 4242003
POWDER INTRAVENOUS SINGLE-DOSE VIAL
35 MG ( 35 MGVIAL )
Trade Name
Proper Name
LEMTRADA
ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 22 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENZYME CORP 1596
103948 5139 2 11142014 12 MG12 ML ( 10MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name LUMIZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125291 0 1 5242010 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name NUCALA
Proper Name MEPOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125526 0 1 11142015
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
TANZEUM
ALBIGLUTIDE
BLASTN
125431 0
Product
1
Approval Date
4152014
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS AUTOINJECTOR
30 MG ( 30 MGAUTOINJECTOR )
125431 0 2 4152014
POWDER SUBCUTANEOUS AUTOINJECTOR
50 MG ( 50 MGAUTOINJECTOR )
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name PEGASYS
Proper Name PEGINTERFERON ALFA 2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103964 5204 4 9292011 180 MCG05 ML ( 360 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 23 of 42
CDER Billable Biologic Product List
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Proper Name PEG-INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103964 0 1 10162002 180 MCGML ( 180 MCGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
103964 0 2 10162002 180 MCG05 ML ( 360 MCGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
103964 5204 3 9292011 135 MCG05 ML ( 270 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
ApplicantLicense No HORIZON PHARMA IRELAND LTD 2022
Trade Name ACTIMMUNE
Proper Name INTERFERON GAMMA-1B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103836 0 1 2251999 100 MCG05 ML ( 200 MCGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No HORIZON PHARMA RHEUMATOLOGY LLC 1998
Trade Name KRYSTEXXA
Proper Name PEGLOTICASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125293 0 1 9142010 8MGML ( 8MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 24 of 42
CDER Billable Biologic Product List
ApplicantLicense No HUMAN GENOME SCIENCES INC 1820
Trade Name BENLYSTA
Proper Name BELIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125370 0 1 392011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
120 MG ( 120 MGVIAL )
125370 0 2 392011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
400 MG ( 400 MGVIAL )
125370 0 3 392011
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )
125370 0 4 392011
SOLUTION SUBCUTANEOUS AUTOINJECTOR
200 MGML ( 200 MGML )
BLASTN
761043 0
Product
1
Approval Date
7202017
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )
Trade Name
Proper Name
RAXIBACUMAB
RAXIBACUMAB
BLASTN
125349 0
Product
1
Approval Date
12142012
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1700 MG34 ML ( 50 MGML )
ApplicantLicense No IMCLONE LLC 1695
Trade Name ERBITUX
Proper Name CETUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125084 0 1 2122004 100 MG50 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 25 of 42
CDER Billable Biologic Product List
ApplicantLicense No IMCLONE LLC 1695
125084 0 2 2122004 200 MG100 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No IMMUNEX CORP 1132
Trade Name ENBREL
Proper Name ETANERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103795 0 1 1121998
POWDER SUBCUTANEOUS MULTI-DOSE VIAL
25 MG ( 25 MGVIAL )
103795 5184 2 9272004
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
50 MGML ( 50 MGML )
103795 0 3 9272004
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MGML ( 50 MGML )
103795 5184 4 9272004
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
25 MG05 ML ( 50 MGML )
103795 5556 5 9142017
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MGML ( 50 MGML )
ApplicantLicense No IPSEN BIOPHARM LIMITED 1787
Trade Name DYSPORT
Proper Name ABOBOTULINUMTOXINA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125274 0 1 4292009
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
300 UNITS ( 300 UNITSVIAL )
125274 0 2 4292009
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
500 UNITS ( 500 UNITSVIAL )
March 2018 Page 26 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
Trade Name DARZALEX
Proper Name DARATUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761036 0 1 11162015
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG5 ML ( 20 MGML )
761036 0 2 11162015
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
400 MG20 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
103772 0
REMICADE
INFLIXIMAB
Approval Date Product
8241998 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
BLASTN
103575 0
REOPRO
ABCIXIMAB
Approval Date Product
12221994 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
10 MG5 ML ( 2 MGML )
Trade Name
Proper Name
BLASTN
125289 0
SIMPONI
GOLIMUMAB
Approval Date Product
4242009 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
50 MG05 ML ( 100 MGML )
125289 0 2 4242009
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MG05 ML ( 100 MGML )
125289 0 3 4242009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
100 MGML ( 100 MGML )
March 2018 Page 27 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
125289 0 4 4242009 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name SIMPONI ARIA
Proper Name GOLIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125433 0 1 7182013 50 MG4 ML ( 125 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name STELARA
Proper Name USTEKINUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125261 0 1 9252009 90 MGML ( 90 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125261 0 2 9252009 45 MG05 ML ( 90 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL amp PREFILLED SYRINGE
125261 0 3 9252009 130 MG26 ML ( 5 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761044 0 1 9232016 130 MG26 ML ( 5 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SYLVANT
Proper Name SILTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125496 0 1 4232014 100 MG ( 100 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125496 0 2 4232014 400 MG ( 400 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 28 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
Trade Name TREMFYA
Proper Name GUSELKUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761061 0 1 7132017 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No JAZZ PHARMACEUTICALS INC 1901
Trade Name ERWINAZE
Proper Name ASPARAGINASE ERWINIA CHRYSANTHEMI
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
105359 0 1 11182011 10000 IU ( 10000 IUVIAL )
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103770 0 1 6191998
SOLUTION INTRAMUSCULAR
50 MG05 ML ( 100 MGML )
SINGLE-DOSE VIAL
103770 0 2 6191998
SOLUTION INTRAMUSCULAR
100 MGML ( 100 MGML )
SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name ILUMYA
Proper Name TILDRAKIZUMAB-ASMN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761067 0 1 3202018 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name INTRON A
March 2018 Page 29 of 42
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103132 0 1 641986 10 MIU ( 10 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL INTRAVENOUS SINGLE-DOSE VIAL
103132 0 2 641986 18 MIU ( 18 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL
103132 0 3 641986 50 MIU ( 50 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL
103132 0 4 641986 228 MIU38 ML ( 6 MIUML )
SOLUTION INTRAMUSCULAR SUBCUTANEOUS MULTI-DOSE VIAL
103132 0 5 641986 32 MIU32 ML ( 10 MIUML )
SOLUTION INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL MULTI-DOSE VIAL
Trade Name KEYTRUDA
Proper Name PEMBROLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125514 0 1 942014 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125514 1 2 1152015 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 0 1 1192001 74 MCG ( 74 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SYLATRON
Proper Name PEGINTERFERON ALFA-2B
March 2018 Page 30 of 42
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 5153 2 3292011 296 MCG ( 296 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 3 3292011 444 MCG ( 444 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 4 3292011 888 MCG ( 888 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name ZINPLAVA
Proper Name BEZLOTOXUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761046 0 1 10212016 1000 MG40 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No MERZ PHARMACEUTICALS GMBH 1830
Trade Name XEOMIN
Proper Name INCOBOTULINUMTOXINA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125360 0 1 7302010
POWDER INTRAMUSCULAR
50 U ( 50 UVIAL )
SINGLE-DOSE VIAL
125360 0 2 7302010
POWDER INTRAMUSCULAR
100 U ( 100 UVIAL )
SINGLE-DOSE VIAL
125360 3 3 11202015
POWDER INTRAMUSCULAR
200 U ( 200 UVIAL )
SINGLE-DOSE VIAL
March 2018 Page 31 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
Trade Name ARZERRA
Proper Name OFATUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125326 0 1 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG5 ML ( 20 MGML )
125326 0 2 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1000 MG50 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
125504 0
COSENTYX
SECUKINUMAB
Approval Date Product
1212015 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
150 MG ( 150 MGVIAL )
125504 0 2 1212015
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MGML ( 150 MGML )
125504 0 3 1212015
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MGML ( 150 MGML )
Trade Name
Proper Name
BLASTN
125290 0
EXTAVIA
INTERFERON BETA-1B
Approval Date Product
8142009 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
03 MG ( 03 MGVIAL )
Trade Name
Proper Name
BLASTN
125319 0
ILARIS
CANAKINUMAB
Approval Date Product
6172009 1
PotencyDosage FormRoutePresentation
180 MGVIAL ( 180 MGVIAL )
March 2018 Page 32 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
125319 88 2 12222016 150 MG ( 150 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
125319 0 3 12222016 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SIMULECT
Proper Name BASILIXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103764 0 1 5121998 10 MG ( 10 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
103764 0 2 5121998 20 MG ( 20 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No NPS PHARMACEUTICALS INC 1908
Trade Name NATPARA
Proper Name PARATHYROID HORMONE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 33 of 42
CDER Billable Biologic Product List
ApplicantLicense No PROMETHEUS LABORATORIES INC 1848
Trade Name PROLEUKIN
Proper Name ALDESLEUKIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103293 0 1 551992 22 MIU ( 22 MIUVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760
Trade Name ARCALYST
Proper Name RILONACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125249 0 1 2272008
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
220MG ( 220MGVIAL )
Trade Name
Proper Name
DUPIXENT
DUPILUMAB
BLASTN
761055 0
Product
1
Approval Date
3282017
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
300 MG2 ML ( 150 MGML )
Trade Name
Proper Name
EYLEA
AFLIBERCEPT
BLASTN
125387 0
Product
1
Approval Date
11182011
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
2 MG005 ML ( 40 MGML )
March 2018 Page 34 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Trade Name ELITEK
Proper Name RASBURICASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103946 0 1 7122002
POWDER INTRAVENOUS SINGLE-DOSE VIAL
15 MG ( 15 MGVIAL )
103946 5020 2 162006
POWDER INTRAVENOUS SINGLE-DOSE VIAL
75 MG ( 75 MGVIAL )
Trade Name
Proper Name
BLASTN
761037 0
KEVZARA
SARILUMAB
Approval Date Product
5222017 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MG114 ML ( 13158 MGML )
761037 0 2 5222017
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MG114 ML ( 17544 MGML )
761037 1 3 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MG114 ML ( 13158 MGML )
761037 1 4 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
200 MG114 ML ( 17544 MGML )
Trade Name
Proper Name
BLASTN
103362 0
LEUKINE
SARGRAMOSTIM
Approval Date Product
351991 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
250 MCG ( 250 MCGVIAL )
103362 0 2 351991
SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL
500 MCGML ( 500 MCGML )
Trade Name PRALUENT
March 2018 Page 35 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Proper Name ALIROCUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125559 0 1 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 2 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 3 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125559 0 4 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name ZALTRAP
Proper Name ZIV-AFLIBERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125418 0 1 832012 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125418 0 2 832012 200 MG8 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SEATTLE GENETICS INC 1853
Trade Name ADCETRIS
Proper Name BRENTUXIMAB VEDOTIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125388 1 1 8192011 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 36 of 42
CDER Billable Biologic Product List
ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593
Trade Name ELAPRASE
Proper Name IDURSULFASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125151 0 1 7242006 6 MG3 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SICOR BIOTECH UAB 1803
Trade Name GRANIX
Proper Name TBO-FILGRASTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125294 0 1 8292012
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
300 MCG0 5 ML ( 600 MCGML )
125294 0 2 8292012
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
480 MCG08 ML ( 600 MCGML )
ApplicantLicense No SMITH AND NEPHEW INC 2004
Trade Name REGRANEX
Proper Name BECAPLERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103691 0 1 12161997
GEL TOPICAL
100 UG ( 100 UGGM )
Trade Name
Proper Name
SANTYL
COLLAGENASE
BLASTN
101995 0
Product
1
Approval Date
641965
PotencyDosage FormRoutePresentation
OINTMENT TOPICAL
30 G amp 90 G TUBE ( 250 UGRAM )
March 2018 Page 37 of 42
CDER Billable Biologic Product List
ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718
Trade Name MYOBLOC
Proper Name RIMABOTULINUM TOXIN B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103846 0 1 1282002
SOLUTION INTRAMUSCULAR
2500 IU05 ML ( 5000 IUML )
SINGLE-DOSE VIAL
103846 0 3 1282002
SOLUTION INTRAMUSCULAR
10000 IU2 ML ( 5000 IUML )
SINGLE-DOSE VIAL
Proper Name RIMABOTULINUMTOXINB
BLASTN
103846 0
Product
2
Approval Date
1282002
PotencyDosage FormRoutePresentation
SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL
5000 IUML ( 5000 IUML )
ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832
Trade Name ZEVALIN
Proper Name IBRITUMOMAB TIUXETAN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125019 0 1 2192002 32 MG2 ML ( 16 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
Trade Name KEPIVANCE
Proper Name PALIFERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125103 0 1 12152004 625 MG ( 625 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name KINERET
Proper Name ANAKINRA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 38 of 42
CDER Billable Biologic Product List
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898
Trade Name ENTYVIO
Proper Name VEDOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125476 0 1 5202014 300 MG ( 300 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No TEVA RESPIRATORY LLC 2047
Trade Name CINQAIR
Proper Name RESLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761033 0 1 3232016 100 MG10 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No THERATECHNOLOGIES INC 2091
Trade Name TROGARZO
Proper Name IBALIZUMAB-UIYK
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761065 0 1 362018 200 MG133 ML ( 150 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 39 of 42
CDER Billable Biologic Product List
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
0375 MG03 ML ( 125 MGML )2222017 125422 038 1
ApplicantLicense No UCB INC 1736
Trade Name CIMZIA
Proper Name CERTOLIZUMAB PEGOL
BLASTN Approval Date PotencyDosage FormRoutePresentation Product
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
200 MG ( 200 MGVIAL ) 4222008 125160 0 1
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )5132009 125160 080 2
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
Trade Name CRYSVITA
Proper Name BUROSUMAB-TWZA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761068 0 1 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
10 MGML ( 10 MGML )
761068 0 2 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
20 MGML ( 20 MGML )
761068 0
Trade Name
Proper Name
BLASTN
March 2018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML ) 4172018 3
MEPSEVII
VESTRONIDASE ALFA-VJBK
Approval Date PotencyDosage FormRoutePresentation Product
Page 40 of 42
CDER Billable Biologic Product List
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
761047 0 1 11152017 10 MG5 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No UNITED THERAPEUTICS CORP 1993
Trade Name UNITUXIN
Proper Name DINUTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125516 0 1 3102015 175 MG5 ML ( 35 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053
Trade Name SILIQ
Proper Name BRODALUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761032 0 1 2152017 210 MG15 ML ( 140 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 41 of 42
CDER Billable Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No WYETH PHARMACEUTICALS INC 0003
Trade Name BESPONSA
Proper Name INOTUZUMAB OZOGAMICIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761040 0 1 8172017 09 MG ( 09 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 42 of 42
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 1 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
9172001 103951 0 26
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
200 MCGML ( 200 MCGML ) 09272012
103951 0 27 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
200 MCG04 ML ( 500 MCGML ) 09272012
103951 0 28 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
300 MCGML ( 300 MCGML ) 09272012
103951 0 29 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
300 MCG06 ML ( 500 MCGML ) 09272012
103951 0 30 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
500 MCGML ( 500 MCGML ) 09272012
ApplicantLicense No ASTELLAS PHARMACEUTICALS US INC 1748
Trade Name AMEVIVE
Proper Name ALEFACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125036 0 1 1302003 75 MGVIAL ( 75 MGVIAL ) 09242008
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
125036 0 2 1302003 15 MGVIAL ( 15 MGVIAL ) 09282012
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No BOEHRINGER INGELHEIM PHARMA KG 1251
Trade Name VERLUMA
Proper Name NOFETUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103769 0 1 10131998 10 MGML ( 10 MGML ) 08132013
INTRAVENOUS
March 2018 Page 2 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No CENTOCOR ORTHO BIOTECH PRODUCTS LP 1824
Trade Name ORTHOCLONE OKT3
Proper Name MUROMONAB-CD3
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103463 0 1 9141992 1 MGML ( 1 MGML ) 01112012
SOLUTION INTRAVENOUS AMPULE
ApplicantLicense No EISAI INCORPORATED 1862
Trade Name ONTAK
Proper Name DENILEUKIN DIFTITOX
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103767 0 1 251999 300 MCG2 ML ( 150 MCGML ) 01302014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No ELI LILLY AND CO 1611
Trade Name XIGRIS
Proper Name DROTRECOGIN ALFA (ACTIVATED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125029 0 1 11212001 5 MGVIAL ( 5 MGVIAL ) 10262011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125029 0 2 11212001 20 MGVIAL ( 20 MGVIAL ) 10102011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GENENTECH INC 1048
Trade Name RAPTIVA
Proper Name EFALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125075 0 1 10272003 125 MGVIAL ( 125 MGVIAL ) 09012009
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
March 2018 Page 3 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103976 0 2 6202003 125 MGVIAL ( 125 MGVIAL ) 08252016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103948 0 3 572001 10 MGVIAL ( 10 MGVIAL ) 07062011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name MYOZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125141 0 1 4282006 50 MGVIAL ( 50 MGVIAL ) 10172014
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name BEXXAR THERAPEUTIC REGIME
Proper Name TOSITUMOMAB AND IODINE I-131 TOSITUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125011 0 1 6272003 01 MGML I-131 TOSITUMOMAB ( 01 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 2 6272003 11 MGML I-131 TOSITUMOMAB ( 11 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 3 6272003 14 MGML TOSITUMOMAB ( 14 MGML 03102014 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 4 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No HEMISPHERX BIOPHARMA INC 1703
Trade Name ALFERON N INJECTION
Proper Name INTERFERON ALFA-N3 (HUMAN LEUKOCYTE DERIVED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103158 0 1 10101989 5 MIUVIAL ( 5 MIUVIAL ) 06272013
SOLUTION INTRALESIONAL MULTI-DOSE VIAL
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name ROFERON A
Proper Name INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103145 0 1 641986 3 MIU05 ML ( 3 MIU05 ML ) 06012009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name ZENAPAX
Proper Name DACLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103749 0 1 12101997 25 MG5 ML ( 25 MG5 ML ) 07072011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No KADMON PHARMACEUTICALS LLC 1867
Trade Name INFERGEN
Proper Name INTERFERON ALFACON-1
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103663 0 1 1061997 9 MCG03 ML ( 30 MCGML ) 07252013
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 5 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103770 0 3 6191998 50 MGVIAL ( 50 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
103770 0 4 6191998 100 MGVIAL ( 100 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name INTRON A
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103132 0 6 641986 10 MIUML ( 10 MIUML ) 09232013
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103132 0 7 641986 225 MIU15 ML ( 225 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 8 641986 375 MIU15 ML ( 375 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 9 641986 75 MIU15 ML ( 75 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103949 0 5 1192001 675 MCGPEN ( 675 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 6 1192001 108 MCGPEN ( 108 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
March 2018 Page 6 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name PEGINTRON
103949 0 7 1192001 1184 MCGVIAL ( 1184 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 8 1192001 162 MCGPEN ( 162 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 9 1192001 1776 MCGVIAL ( 1776 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 10 1192001 2025 MCGPEN ( 2025 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 11 1192001 222 MCGVIAL ( 222 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No PALATIN TECHNOLOGIES INC 1588
Trade Name NEUTROSPEC TECHNETIUM (99M TC)
Proper Name FANOLESOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103928 0 1 722004 025 MGVIAL ( 025 MGVIAL ) 09222008
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No RECORDATI RARE DISEASES INC 1899
Trade Name ELSPAR
Proper Name ASPARAGINASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
101063 0 1 1101978 10000 IU ( 10000 IUVIAL ) 04092014
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
March 2018 Page 7 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No SCHERING CORP 0994
Trade Name PEGINTRONREBETOL COMBO PACK
Proper Name PEGINTERFERON ALFA-2B AND RIBAVIRIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125196 0 1 6132008 ( 4 (120 MCG05ML) REDIPEN amp 140 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 2 6132008 ( 4 (150 MCG05ML) REDIPEN amp 168 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 3 6132008 ( 4 (150 MCG05ML) REDIPEN amp 196 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 4 6132008 ( 4 (50 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 5 6132008 ( 4 (80 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125422 0 2 10172012 05 MG ( 25 MGML ) 08082017
SOLUTION INTRAVETREAL SINGLE-DOSE VIAL
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125164 0 10 11142007 50 MCGML ( 50 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 8 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
125164 0 11 11142007 100 MCGML ( 100 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 12 11142007 200 MCGML ( 200 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 13 11142007 300 MCGML ( 300 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 14 11142007 400 MCGML ( 400 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 15 11142007 400 MCG06 ML ( 400 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 16 11142007 600 MCGML ( 600 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 17 11142007 600 MCG06 ML ( 600 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 18 11142007 800 MCG06 ML ( 800 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 19 11142007 1000 MCGML ( 1000 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 9 of 9
CDER Billable Biologic Product List
ApplicantLicense No ALLERGAN INC 1145
Proper Name BOTULINUM TOXIN TYPE A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103000 5000 2 4122002 100 U ( 100 UVIAL )
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
103000 5101 4 4142005 50 U ( 50 UVIAL )
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
Proper Name DARBEPOETIN ALFA IN POLYSORBATE SOLUTION
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103951 0 1 9172001 25 MCGML ( 25 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 2 9172001 40 MCGML ( 40 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 3 9172001 60 MCGML ( 60 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 4 9172001 100 MCGML ( 100 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 5 9172001 150 MCG075 ML ( 150 MCG075 ML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 6 9172001 200 MCGML ( 200 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 7 9172001 300 MCGML ( 300 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 4 of 42
CDER Billable Biologic Product List
ApplicantLicense No AMGEN INC 1080
103951 0 8 9172001 25 MCG042 ML ( 25 MCG042 ML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 9 9172001 40 MCG04 ML ( 40 MCG04 ML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 10 9172001 60 MCG03 ML ( 60 MCG03 ML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 11 9172001 100 MCG05 ML ( 100 MCG05 ML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 12 9172001 150 MCG03 ML ( 150 MCG03 ML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 13 9172001 200 MCG04 ML ( 200 MCG04 ML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 14 9172001 300 MCG06 ML ( 300 MCG06 ML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 15 9172001 500 MCGML ( 500 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 31 9172001 10 MCG04 ML ( 10 MCG04 ML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
Trade Name BLINCYTO
Proper Name BLINATUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125557 0 1 1232014 35 MCG ( 35 MCGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name EPOGEN
Proper Name EPOETIN ALFA
March 2018 Page 5 of 42
CDER Billable Biologic Product List
ApplicantLicense No AMGEN INC 1080
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103234 0 6 611989 10000 UML ( 10000 UML )
SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL
103234 0 7 611989 20000 UML ( 10000 UML )
SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL
Proper Name EPOETIN ALFA - PRESERVATIVE FREE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103234 0 1 611989 2000 UML ( 2000 UML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103234 0 2 611989 3000 UML ( 3000 UML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103234 0 3 611989 4000 UML ( 4000 UML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103234 0 4 611989 10000 UML ( 10000 UML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name NEULASTA
Proper Name PEGFILGRASTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125031 0 1 1312002 6 MG06 ML ( 10 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name NEULASTA ONPRO
Proper Name PEGFILGRASTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125031 181 2 9232015 6 MG06 ML ( 10 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name NEUPOGEN
March 2018 Page 6 of 42
CDER Billable Biologic Product List
ApplicantLicense No AMGEN INC 1080
Proper Name FILGRASTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103353 0 1 2201991 300 MCGML ( 300 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103353 0 2 2201991 300 MCG05 ML ( 600 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103353 0 3 2201991 480 MCG16 ML ( 300 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103353 0 4 2201991 480 MCG08 ML ( 600 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
Trade Name NPLATE
Proper Name ROMIPLOSTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125268 0 1 8222008 250 MCG ( 250 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
125268 0 2 8222008 500 MCG ( 500 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name PROCRIT
Proper Name EPOETIN ALFA - PRESERVATIVE FREE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103234 0 5 611989 40000 UML ( 40000 UML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name PROLIA
Proper Name DENOSUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 7 of 42
CDER Billable Biologic Product List
ApplicantLicense No AMGEN INC 1080
125320 0 1 612010 60 MGML ( 60 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name REPATHA
Proper Name EVOLOCUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125522 0 1 8272015 140 MGML ( 140 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125522 1 2 7112016 420 MG35 ML ( 120 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125522 0 3 8272015 140 MGML ( 140 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name VECTIBIX
Proper Name PANITUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125147 0 1 9272006 100 MG5 ML ( 20 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125147 0 2 9272006 200 MG10 ML ( 20 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125147 0 3 9272006 400 MG20 ML ( 20 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name XGEVA
Proper Name DENOSUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125320 7 2 11182010 120 MG17 ML ( 70 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 8 of 42
CDER Billable Biologic Product List
ApplicantLicense No ASTRAZENECA UK LTD 2043
Trade Name FASENRA
Proper Name BENRALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761070 0 1 11142017
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
30 MGML ( 30 MGML )
Trade Name
Proper Name
IMFINZI
DURVALUMAB
BLASTN
761069 0
Product
1
Approval Date
512017
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
120 MG24 ML ( 50 MGML )
761069 0 2 512017
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
500 MG10 ML ( 50 MGML )
ApplicantLicense No AUXILIUM PHARMACEUTICALS INC 1816
Trade Name XIAFLEX
Proper Name CLOSTRIDIAL COLLAGENASE HISTOLYTICUM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125338 0 1 222010 09 MG ( 09 MGVIAL )
POWDER INTRALESIONAL SINGLE-DOSE VIAL
ApplicantLicense No AYTU BIOSCIENCES INC 2035
Trade Name PROSTASCINT
Proper Name CAPROMAB PENDETIDE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103608 0 1 10281996 05 MGML ( 05 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 9 of 42
CDER Billable Biologic Product List
ApplicantLicense No BAXALTA US INC 2020
Trade Name ONCASPAR
Proper Name PEGASPARGASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103411 0 1 211994 3750 IU5 ML ( 750 IUML )
SOLUTION INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No BAYER HEALTHCARE PHARMACEUTICALS INC 1778
Trade Name BETASERON
Proper Name INTERFERON BETA-1B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103471 0 1 7231993 03 MG ( 03 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No BIOGEN INC 1697
Trade Name AVONEX
Proper Name INTERFERON BETA 1A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103628 0 1 5171996
POWDER INTRAMUSCULAR
30 MCG ( 30 MCGVIAL )
SINGLE-DOSE VIAL
103628 0 2 5171996
SOLUTION INTRAMUSCULAR PREFILLED SYRINGE
30 MCG05 ML ( 30 MCG05 ML )
103628 0 3 5171996
SOLUTION INTRAMUSCULAR AUTOINJECTOR
30 MCG05 ML ( 30 MCG05 ML )
Trade Name
Proper Name
BLASTN
125499 0
PLEGRIDY
PEGINTERFERON BETA-1A
Approval Date PotencyDosage FormRoutePresentation Product
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
63 MCG05 ML ( 126 MCGML ) 8152014 1
March 2018 Page 10 of 42
CDER Billable Biologic Product List
ApplicantLicense No BIOGEN INC 1697
125499 0 2 8152014 125 MCG05 ML ( 250 MCGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125499 0 3 8152014 63 MCG05 ML ( 126 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125499 0 4 8152014 94 MCG05 ML ( 188 MCGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125499 0 5 8152014 94 MCG05 ML ( 188 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125499 0 6 8152014 125 MCG05 ML ( 250 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name TYSABRI
Proper Name NATALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125104 0 1 11232004 300 MG15 ML ( 20 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name ZINBRYTA
Proper Name DACLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761029 0 1 5272016 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
761029 0 2 5272016 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 11 of 42
CDER Billable Biologic Product List
ApplicantLicense No BIOMARIN PHARMACEUTICAL INC 1649
Trade Name ALDURAZYME
Proper Name LARONIDASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125058 0 1 4302003
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
29 MG5 ML ( 058 MGML )
Trade Name
Proper Name
BRINEURA
CERLIPONASE ALFA
BLASTN
761052 0
Product
1
Approval Date
4272017
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENTRICULAR SINGLE-DOSE VIAL
150 MG5 ML ( 30 MGML )
Trade Name
Proper Name
NAGLAZYME
GALSULFASE
BLASTN
125117 0
Product
1
Approval Date
5312005
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
5 MG 5ML ( 1 MGML )
Trade Name
Proper Name
VIMIZIM
ELOSULFASE ALFA
BLASTN
125460 0
Product
1
Approval Date
2142014
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
5 MG5 ML ( 1 MGML )
ApplicantLicense No BOEHRINGER INGELHEIM PHARMACEUTICALS INC 2006
Trade Name PRAXBIND
Proper Name IDARUCIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761025 0 1 10162015 2500 MG50 ML ( 50 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 12 of 42
CDER Billable Biologic Product List
ApplicantLicense No BRISTOL MYERS SQUIBB CO 1713
Trade Name EMPLICITI
Proper Name ELOTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761035 0 1 11302015
POWDER INTRAVENOUS SINGLE-DOSE VIAL
300 MG ( 300 MGVIAL )
761035 0 2 11302015
POWDER INTRAVENOUS SINGLE-DOSE VIAL
400 MG ( 400 MGVIAL )
Trade Name
Proper Name
BLASTN
125288 0
NULOJIX
BELATACEPT
Approval Date Product
6152011 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
250 MG ( 250 MGVIAL )
Trade Name
Proper Name
BLASTN
125554 0
OPDIVO
NIVOLUMAB
Approval Date Product
12222014 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
40 MG4 ML ( 10 MGML )
125554 0 2 12222014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG10 ML ( 10 MGML )
125554 0 3 12222014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
240 MG24 ML ( 10 MGML )
Trade Name
Proper Name
BLASTN
125118 0
ORENCIA
ABATACEPT
Approval Date Product
12232005 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
250 MG ( 250 MGVIAL )
March 2018 Page 13 of 42
CDER Billable Biologic Product List
ApplicantLicense No BRISTOL MYERS SQUIBB CO 1713
125118 122 2 7292011 50 MG04 ML ( 125 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125118 122 3 7292011 875 MG07 ML ( 125 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125118 122 4 7292011 125 MGML ( 125 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125118 122 5 7292011 125 MGML ( 125 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name YERVOY
Proper Name IPILIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125377 0 1 3252011 50 MG10 ML ( 5 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125377 0 2 3252011 200 MG40 ML ( 5 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No BTG INTERNATIONAL INC 1861
Trade Name VORAXAZE
Proper Name GLUCARPIDASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125327 0 1 1172012 1000 U ( 1000 UVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 14 of 42
CDER Billable Biologic Product List
ApplicantLicense No DYAX CORPORATION 1789
Trade Name KALBITOR
Proper Name ECALLANTIDE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125277 0 1 1212009 10 MGML ( 10 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No EKR THERAPEUTICS INC 1814
Trade Name RETAVASE
Proper Name RETEPLASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103786 0 1 561998 10 U ( 10 UVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No ELI LILLY AND CO 1891
Trade Name CYRAMZA
Proper Name RAMUCIRUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125477 0 1 4212014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG10 ML ( 10 MGML )
125477 0 2 4212014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
500 MG50 ML ( 10 MGML )
Trade Name
Proper Name
BLASTN
761038 0
LARTRUVO
OLARATUMAB
Approval Date Product
10192016 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
500 MG50 ML ( 10 MGML )
761038 0 2 10192016
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
190 MG19 ML ( 10 MGML )
March 2018 Page 15 of 42
CDER Billable Biologic Product List
ApplicantLicense No ELI LILLY AND CO 1891
Trade Name PORTRAZZA
Proper Name NECITUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125547 0 1 11242015
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
800 MG50 ML ( 16 MGML )
Trade Name
Proper Name
TALTZ
IXEKIZUMAB
BLASTN
125521 0
Product
1
Approval Date
3222016
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
80 MGML ( 80 MGML )
125521 0 2 3222016
SOLUTION SUBCUTANEOUS AUTOINJECTOR
80 MGML ( 80 MGML )
Trade Name
Proper Name
TRULICITY
DULAGLUTIDE
BLASTN
125469 0
Product
1
Approval Date
9182014
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
075 MG05 ML ( 075 MG05 ML )
125469 0 2 9182014
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
15 MG05 ML ( 15 MG05 ML )
125469 0 3 9182014
SOLUTION SUBCUTANEOUS AUTOINJECTOR
075 MG05 ML ( 075 MG05 ML )
125469 0 4 9182014
SOLUTION SUBCUTANEOUS AUTOINJECTOR
15 MG05 ML ( 15 MG05 ML )
March 2018 Page 16 of 42
CDER Billable Biologic Product List
ApplicantLicense No ELUSYS THERAPEUTICS INC 1907
Trade Name ANTHIM
Proper Name OBILTOXAXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125509 1 1 3182016 600 MG6 ML ( 100 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No EMD SERONO INC 1773
Trade Name BAVENCIO
Proper Name AVELUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761049 0 1 3232017
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
200 MG10 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
103780 0
REBIF
INTERFERON BETA 1A
Approval Date Product
372002 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
88 MCG02 ML ( 44 MCGML )
103780 0 2 372002
SOLUTION SUBCUTANEOUS AUTOINJECTOR
88 MCG02 ML ( 44 MCGML )
103780 0 3 372002
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
22 MCG05 ML ( 44 MCGML )
103780 0 4 372002
SOLUTION SUBCUTANEOUS AUTOINJECTOR
22 MCG05 ML ( 44 MCGML )
103780 0 5 372002
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
44 MCG05 ML ( 88 MCGML )
103780 0 6 372002
SOLUTION SUBCUTANEOUS AUTOINJECTOR
44 MCG05 ML ( 88 MCGML )
March 2018 Page 17 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name ACTEMRA
Proper Name TOCILIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125276 0 1 182010
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
80 MG4 ML ( 20 MGML )
125276 0 2 182010
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
200 MG10 ML ( 20 MGML )
125276 0 3 182010
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
400 MG20 ML ( 20 MGML )
BLASTN
125472 1
Product
1
Approval Date
10212013
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
162 MG09 ML ( 179 MGML )
Trade Name
Proper Name
BLASTN
103172 0
ACTIVASE
ALTEPLASE
Approval Date Product
11131987 2
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
50 MG ( 50 MGVIAL )
103172 0 3 11131987
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
BLASTN
125085 0
AVASTIN
BEVACIZUMAB
Approval Date Product
2262004 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG4 ML ( 25 MGML )
125085 0 2 2262004
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
400 MG16 ML ( 25 MGML )
March 2018 Page 18 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name CATHFLO ACTIVASE
Proper Name ALTEPLASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103172 0 1 11131987
POWDER INTRACATHETER SINGLE-DOSE VIAL
2 MG ( 2 MGVIAL )
Trade Name
Proper Name
BLASTN
125486 0
GAZYVA
OBINUYUZUMAB
Approval Date Product
1112013 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1000 MG40 ML ( 25 MGML )
Trade Name
Proper Name
BLASTN
761083 0
HEMLIBRA
EMICIZUMAB-KXWH
Approval Date Product
11162017 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML )
761083 0 2 11162017
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
60 MG04 ML ( 150 MGML )
761083 0 3 11162017
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
105 MG07 ML ( 150 MGML )
761083 0 4 11162017
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
150 MGML ( 150 MGML )
Trade Name
Proper Name
BLASTN
103792 0
HERCEPTIN
TRASTUZUMAB
Approval Date Product
9251998 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS MULTI-DOSE VIAL
420 MG ( 420 MGVIAL )
March 2018 Page 19 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
103792 5336 2 2102017 150 MG ( 150 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name KADCYLA
Proper Name ADO-TRASIUZUMAB EMTANSINE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125427 0 1 2222013
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
125427 0 2 2222013
POWDER INTRAVENOUS SINGLE-DOSE VIAL
160 MG ( 160 MGVIAL )
Trade Name
Proper Name
LUCENTIS
RANIBIZUMAB
BLASTN
125156 0
Product
1
Approval Date
6302006
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE
05 MG005 ML ( 10 MGML )
Proper Name RANIDIZUMAB
BLASTN
125156 076
Product
2
Approval Date
8102012
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE
03 MG005 ML ( 6 MGML )
Trade Name
Proper Name
OCREVUS
OCRELIZUMAB
BLASTN
761053 0
Product
1
Approval Date
3282017
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
300 MG10 ML ( 30 MGML )
Trade Name
Proper Name
PERJETA
PERTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 20 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
125409 0 1 682012 420 MG14 ML ( 30 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name PULMOZYME
Proper Name DORNASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103532 0 1 12301993 25 MG25 ML ( 1 MGML )
SOLUTION INHALATION AMPULE
Trade Name RITUXAN
Proper Name RITUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103705 0 1 11261997 100 MG10 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
103705 0 2 11261997 500 MG50 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name RITUXAN HYCELA
Proper Name RITUXIMAB AND HYALURONIDASE HUMAN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761064 0 1 6222017 1400 MG AND 23400 U117 ML ( 11966 MG AND 2000 UML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
761064 0 2 6222017 1600 MG AND 26800 U134 ML ( 11966 MG AND 2000 UML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name TECENTRIQ
Proper Name ATEZOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761034 0 1 582016 1200 MG20 ML ( 60 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name TNKASE
March 2018 Page 21 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Proper Name TENECTEPLASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103909 0 1 622000 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103976 0 1 6202003 150 MG ( 150 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103948 0 1 572001
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML )
Trade Name
Proper Name
FABRAZYME
AGALSIDASE BETA
BLASTN
103979 0
Product
1
Approval Date
4242003
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
5 MG ( 5 MGVIAL )
103979 0 2 4242003
POWDER INTRAVENOUS SINGLE-DOSE VIAL
35 MG ( 35 MGVIAL )
Trade Name
Proper Name
LEMTRADA
ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 22 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENZYME CORP 1596
103948 5139 2 11142014 12 MG12 ML ( 10MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name LUMIZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125291 0 1 5242010 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name NUCALA
Proper Name MEPOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125526 0 1 11142015
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
TANZEUM
ALBIGLUTIDE
BLASTN
125431 0
Product
1
Approval Date
4152014
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS AUTOINJECTOR
30 MG ( 30 MGAUTOINJECTOR )
125431 0 2 4152014
POWDER SUBCUTANEOUS AUTOINJECTOR
50 MG ( 50 MGAUTOINJECTOR )
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name PEGASYS
Proper Name PEGINTERFERON ALFA 2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103964 5204 4 9292011 180 MCG05 ML ( 360 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 23 of 42
CDER Billable Biologic Product List
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Proper Name PEG-INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103964 0 1 10162002 180 MCGML ( 180 MCGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
103964 0 2 10162002 180 MCG05 ML ( 360 MCGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
103964 5204 3 9292011 135 MCG05 ML ( 270 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
ApplicantLicense No HORIZON PHARMA IRELAND LTD 2022
Trade Name ACTIMMUNE
Proper Name INTERFERON GAMMA-1B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103836 0 1 2251999 100 MCG05 ML ( 200 MCGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No HORIZON PHARMA RHEUMATOLOGY LLC 1998
Trade Name KRYSTEXXA
Proper Name PEGLOTICASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125293 0 1 9142010 8MGML ( 8MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 24 of 42
CDER Billable Biologic Product List
ApplicantLicense No HUMAN GENOME SCIENCES INC 1820
Trade Name BENLYSTA
Proper Name BELIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125370 0 1 392011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
120 MG ( 120 MGVIAL )
125370 0 2 392011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
400 MG ( 400 MGVIAL )
125370 0 3 392011
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )
125370 0 4 392011
SOLUTION SUBCUTANEOUS AUTOINJECTOR
200 MGML ( 200 MGML )
BLASTN
761043 0
Product
1
Approval Date
7202017
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )
Trade Name
Proper Name
RAXIBACUMAB
RAXIBACUMAB
BLASTN
125349 0
Product
1
Approval Date
12142012
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1700 MG34 ML ( 50 MGML )
ApplicantLicense No IMCLONE LLC 1695
Trade Name ERBITUX
Proper Name CETUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125084 0 1 2122004 100 MG50 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 25 of 42
CDER Billable Biologic Product List
ApplicantLicense No IMCLONE LLC 1695
125084 0 2 2122004 200 MG100 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No IMMUNEX CORP 1132
Trade Name ENBREL
Proper Name ETANERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103795 0 1 1121998
POWDER SUBCUTANEOUS MULTI-DOSE VIAL
25 MG ( 25 MGVIAL )
103795 5184 2 9272004
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
50 MGML ( 50 MGML )
103795 0 3 9272004
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MGML ( 50 MGML )
103795 5184 4 9272004
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
25 MG05 ML ( 50 MGML )
103795 5556 5 9142017
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MGML ( 50 MGML )
ApplicantLicense No IPSEN BIOPHARM LIMITED 1787
Trade Name DYSPORT
Proper Name ABOBOTULINUMTOXINA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125274 0 1 4292009
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
300 UNITS ( 300 UNITSVIAL )
125274 0 2 4292009
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
500 UNITS ( 500 UNITSVIAL )
March 2018 Page 26 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
Trade Name DARZALEX
Proper Name DARATUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761036 0 1 11162015
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG5 ML ( 20 MGML )
761036 0 2 11162015
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
400 MG20 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
103772 0
REMICADE
INFLIXIMAB
Approval Date Product
8241998 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
BLASTN
103575 0
REOPRO
ABCIXIMAB
Approval Date Product
12221994 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
10 MG5 ML ( 2 MGML )
Trade Name
Proper Name
BLASTN
125289 0
SIMPONI
GOLIMUMAB
Approval Date Product
4242009 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
50 MG05 ML ( 100 MGML )
125289 0 2 4242009
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MG05 ML ( 100 MGML )
125289 0 3 4242009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
100 MGML ( 100 MGML )
March 2018 Page 27 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
125289 0 4 4242009 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name SIMPONI ARIA
Proper Name GOLIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125433 0 1 7182013 50 MG4 ML ( 125 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name STELARA
Proper Name USTEKINUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125261 0 1 9252009 90 MGML ( 90 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125261 0 2 9252009 45 MG05 ML ( 90 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL amp PREFILLED SYRINGE
125261 0 3 9252009 130 MG26 ML ( 5 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761044 0 1 9232016 130 MG26 ML ( 5 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SYLVANT
Proper Name SILTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125496 0 1 4232014 100 MG ( 100 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125496 0 2 4232014 400 MG ( 400 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 28 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
Trade Name TREMFYA
Proper Name GUSELKUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761061 0 1 7132017 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No JAZZ PHARMACEUTICALS INC 1901
Trade Name ERWINAZE
Proper Name ASPARAGINASE ERWINIA CHRYSANTHEMI
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
105359 0 1 11182011 10000 IU ( 10000 IUVIAL )
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103770 0 1 6191998
SOLUTION INTRAMUSCULAR
50 MG05 ML ( 100 MGML )
SINGLE-DOSE VIAL
103770 0 2 6191998
SOLUTION INTRAMUSCULAR
100 MGML ( 100 MGML )
SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name ILUMYA
Proper Name TILDRAKIZUMAB-ASMN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761067 0 1 3202018 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name INTRON A
March 2018 Page 29 of 42
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103132 0 1 641986 10 MIU ( 10 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL INTRAVENOUS SINGLE-DOSE VIAL
103132 0 2 641986 18 MIU ( 18 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL
103132 0 3 641986 50 MIU ( 50 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL
103132 0 4 641986 228 MIU38 ML ( 6 MIUML )
SOLUTION INTRAMUSCULAR SUBCUTANEOUS MULTI-DOSE VIAL
103132 0 5 641986 32 MIU32 ML ( 10 MIUML )
SOLUTION INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL MULTI-DOSE VIAL
Trade Name KEYTRUDA
Proper Name PEMBROLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125514 0 1 942014 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125514 1 2 1152015 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 0 1 1192001 74 MCG ( 74 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SYLATRON
Proper Name PEGINTERFERON ALFA-2B
March 2018 Page 30 of 42
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 5153 2 3292011 296 MCG ( 296 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 3 3292011 444 MCG ( 444 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 4 3292011 888 MCG ( 888 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name ZINPLAVA
Proper Name BEZLOTOXUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761046 0 1 10212016 1000 MG40 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No MERZ PHARMACEUTICALS GMBH 1830
Trade Name XEOMIN
Proper Name INCOBOTULINUMTOXINA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125360 0 1 7302010
POWDER INTRAMUSCULAR
50 U ( 50 UVIAL )
SINGLE-DOSE VIAL
125360 0 2 7302010
POWDER INTRAMUSCULAR
100 U ( 100 UVIAL )
SINGLE-DOSE VIAL
125360 3 3 11202015
POWDER INTRAMUSCULAR
200 U ( 200 UVIAL )
SINGLE-DOSE VIAL
March 2018 Page 31 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
Trade Name ARZERRA
Proper Name OFATUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125326 0 1 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG5 ML ( 20 MGML )
125326 0 2 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1000 MG50 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
125504 0
COSENTYX
SECUKINUMAB
Approval Date Product
1212015 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
150 MG ( 150 MGVIAL )
125504 0 2 1212015
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MGML ( 150 MGML )
125504 0 3 1212015
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MGML ( 150 MGML )
Trade Name
Proper Name
BLASTN
125290 0
EXTAVIA
INTERFERON BETA-1B
Approval Date Product
8142009 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
03 MG ( 03 MGVIAL )
Trade Name
Proper Name
BLASTN
125319 0
ILARIS
CANAKINUMAB
Approval Date Product
6172009 1
PotencyDosage FormRoutePresentation
180 MGVIAL ( 180 MGVIAL )
March 2018 Page 32 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
125319 88 2 12222016 150 MG ( 150 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
125319 0 3 12222016 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SIMULECT
Proper Name BASILIXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103764 0 1 5121998 10 MG ( 10 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
103764 0 2 5121998 20 MG ( 20 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No NPS PHARMACEUTICALS INC 1908
Trade Name NATPARA
Proper Name PARATHYROID HORMONE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 33 of 42
CDER Billable Biologic Product List
ApplicantLicense No PROMETHEUS LABORATORIES INC 1848
Trade Name PROLEUKIN
Proper Name ALDESLEUKIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103293 0 1 551992 22 MIU ( 22 MIUVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760
Trade Name ARCALYST
Proper Name RILONACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125249 0 1 2272008
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
220MG ( 220MGVIAL )
Trade Name
Proper Name
DUPIXENT
DUPILUMAB
BLASTN
761055 0
Product
1
Approval Date
3282017
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
300 MG2 ML ( 150 MGML )
Trade Name
Proper Name
EYLEA
AFLIBERCEPT
BLASTN
125387 0
Product
1
Approval Date
11182011
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
2 MG005 ML ( 40 MGML )
March 2018 Page 34 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Trade Name ELITEK
Proper Name RASBURICASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103946 0 1 7122002
POWDER INTRAVENOUS SINGLE-DOSE VIAL
15 MG ( 15 MGVIAL )
103946 5020 2 162006
POWDER INTRAVENOUS SINGLE-DOSE VIAL
75 MG ( 75 MGVIAL )
Trade Name
Proper Name
BLASTN
761037 0
KEVZARA
SARILUMAB
Approval Date Product
5222017 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MG114 ML ( 13158 MGML )
761037 0 2 5222017
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MG114 ML ( 17544 MGML )
761037 1 3 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MG114 ML ( 13158 MGML )
761037 1 4 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
200 MG114 ML ( 17544 MGML )
Trade Name
Proper Name
BLASTN
103362 0
LEUKINE
SARGRAMOSTIM
Approval Date Product
351991 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
250 MCG ( 250 MCGVIAL )
103362 0 2 351991
SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL
500 MCGML ( 500 MCGML )
Trade Name PRALUENT
March 2018 Page 35 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Proper Name ALIROCUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125559 0 1 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 2 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 3 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125559 0 4 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name ZALTRAP
Proper Name ZIV-AFLIBERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125418 0 1 832012 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125418 0 2 832012 200 MG8 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SEATTLE GENETICS INC 1853
Trade Name ADCETRIS
Proper Name BRENTUXIMAB VEDOTIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125388 1 1 8192011 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 36 of 42
CDER Billable Biologic Product List
ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593
Trade Name ELAPRASE
Proper Name IDURSULFASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125151 0 1 7242006 6 MG3 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SICOR BIOTECH UAB 1803
Trade Name GRANIX
Proper Name TBO-FILGRASTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125294 0 1 8292012
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
300 MCG0 5 ML ( 600 MCGML )
125294 0 2 8292012
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
480 MCG08 ML ( 600 MCGML )
ApplicantLicense No SMITH AND NEPHEW INC 2004
Trade Name REGRANEX
Proper Name BECAPLERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103691 0 1 12161997
GEL TOPICAL
100 UG ( 100 UGGM )
Trade Name
Proper Name
SANTYL
COLLAGENASE
BLASTN
101995 0
Product
1
Approval Date
641965
PotencyDosage FormRoutePresentation
OINTMENT TOPICAL
30 G amp 90 G TUBE ( 250 UGRAM )
March 2018 Page 37 of 42
CDER Billable Biologic Product List
ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718
Trade Name MYOBLOC
Proper Name RIMABOTULINUM TOXIN B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103846 0 1 1282002
SOLUTION INTRAMUSCULAR
2500 IU05 ML ( 5000 IUML )
SINGLE-DOSE VIAL
103846 0 3 1282002
SOLUTION INTRAMUSCULAR
10000 IU2 ML ( 5000 IUML )
SINGLE-DOSE VIAL
Proper Name RIMABOTULINUMTOXINB
BLASTN
103846 0
Product
2
Approval Date
1282002
PotencyDosage FormRoutePresentation
SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL
5000 IUML ( 5000 IUML )
ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832
Trade Name ZEVALIN
Proper Name IBRITUMOMAB TIUXETAN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125019 0 1 2192002 32 MG2 ML ( 16 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
Trade Name KEPIVANCE
Proper Name PALIFERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125103 0 1 12152004 625 MG ( 625 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name KINERET
Proper Name ANAKINRA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 38 of 42
CDER Billable Biologic Product List
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898
Trade Name ENTYVIO
Proper Name VEDOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125476 0 1 5202014 300 MG ( 300 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No TEVA RESPIRATORY LLC 2047
Trade Name CINQAIR
Proper Name RESLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761033 0 1 3232016 100 MG10 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No THERATECHNOLOGIES INC 2091
Trade Name TROGARZO
Proper Name IBALIZUMAB-UIYK
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761065 0 1 362018 200 MG133 ML ( 150 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 39 of 42
CDER Billable Biologic Product List
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
0375 MG03 ML ( 125 MGML )2222017 125422 038 1
ApplicantLicense No UCB INC 1736
Trade Name CIMZIA
Proper Name CERTOLIZUMAB PEGOL
BLASTN Approval Date PotencyDosage FormRoutePresentation Product
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
200 MG ( 200 MGVIAL ) 4222008 125160 0 1
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )5132009 125160 080 2
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
Trade Name CRYSVITA
Proper Name BUROSUMAB-TWZA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761068 0 1 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
10 MGML ( 10 MGML )
761068 0 2 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
20 MGML ( 20 MGML )
761068 0
Trade Name
Proper Name
BLASTN
March 2018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML ) 4172018 3
MEPSEVII
VESTRONIDASE ALFA-VJBK
Approval Date PotencyDosage FormRoutePresentation Product
Page 40 of 42
CDER Billable Biologic Product List
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
761047 0 1 11152017 10 MG5 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No UNITED THERAPEUTICS CORP 1993
Trade Name UNITUXIN
Proper Name DINUTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125516 0 1 3102015 175 MG5 ML ( 35 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053
Trade Name SILIQ
Proper Name BRODALUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761032 0 1 2152017 210 MG15 ML ( 140 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 41 of 42
CDER Billable Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No WYETH PHARMACEUTICALS INC 0003
Trade Name BESPONSA
Proper Name INOTUZUMAB OZOGAMICIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761040 0 1 8172017 09 MG ( 09 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 42 of 42
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 1 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
9172001 103951 0 26
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
200 MCGML ( 200 MCGML ) 09272012
103951 0 27 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
200 MCG04 ML ( 500 MCGML ) 09272012
103951 0 28 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
300 MCGML ( 300 MCGML ) 09272012
103951 0 29 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
300 MCG06 ML ( 500 MCGML ) 09272012
103951 0 30 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
500 MCGML ( 500 MCGML ) 09272012
ApplicantLicense No ASTELLAS PHARMACEUTICALS US INC 1748
Trade Name AMEVIVE
Proper Name ALEFACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125036 0 1 1302003 75 MGVIAL ( 75 MGVIAL ) 09242008
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
125036 0 2 1302003 15 MGVIAL ( 15 MGVIAL ) 09282012
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No BOEHRINGER INGELHEIM PHARMA KG 1251
Trade Name VERLUMA
Proper Name NOFETUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103769 0 1 10131998 10 MGML ( 10 MGML ) 08132013
INTRAVENOUS
March 2018 Page 2 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No CENTOCOR ORTHO BIOTECH PRODUCTS LP 1824
Trade Name ORTHOCLONE OKT3
Proper Name MUROMONAB-CD3
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103463 0 1 9141992 1 MGML ( 1 MGML ) 01112012
SOLUTION INTRAVENOUS AMPULE
ApplicantLicense No EISAI INCORPORATED 1862
Trade Name ONTAK
Proper Name DENILEUKIN DIFTITOX
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103767 0 1 251999 300 MCG2 ML ( 150 MCGML ) 01302014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No ELI LILLY AND CO 1611
Trade Name XIGRIS
Proper Name DROTRECOGIN ALFA (ACTIVATED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125029 0 1 11212001 5 MGVIAL ( 5 MGVIAL ) 10262011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125029 0 2 11212001 20 MGVIAL ( 20 MGVIAL ) 10102011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GENENTECH INC 1048
Trade Name RAPTIVA
Proper Name EFALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125075 0 1 10272003 125 MGVIAL ( 125 MGVIAL ) 09012009
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
March 2018 Page 3 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103976 0 2 6202003 125 MGVIAL ( 125 MGVIAL ) 08252016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103948 0 3 572001 10 MGVIAL ( 10 MGVIAL ) 07062011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name MYOZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125141 0 1 4282006 50 MGVIAL ( 50 MGVIAL ) 10172014
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name BEXXAR THERAPEUTIC REGIME
Proper Name TOSITUMOMAB AND IODINE I-131 TOSITUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125011 0 1 6272003 01 MGML I-131 TOSITUMOMAB ( 01 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 2 6272003 11 MGML I-131 TOSITUMOMAB ( 11 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 3 6272003 14 MGML TOSITUMOMAB ( 14 MGML 03102014 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 4 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No HEMISPHERX BIOPHARMA INC 1703
Trade Name ALFERON N INJECTION
Proper Name INTERFERON ALFA-N3 (HUMAN LEUKOCYTE DERIVED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103158 0 1 10101989 5 MIUVIAL ( 5 MIUVIAL ) 06272013
SOLUTION INTRALESIONAL MULTI-DOSE VIAL
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name ROFERON A
Proper Name INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103145 0 1 641986 3 MIU05 ML ( 3 MIU05 ML ) 06012009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name ZENAPAX
Proper Name DACLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103749 0 1 12101997 25 MG5 ML ( 25 MG5 ML ) 07072011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No KADMON PHARMACEUTICALS LLC 1867
Trade Name INFERGEN
Proper Name INTERFERON ALFACON-1
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103663 0 1 1061997 9 MCG03 ML ( 30 MCGML ) 07252013
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 5 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103770 0 3 6191998 50 MGVIAL ( 50 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
103770 0 4 6191998 100 MGVIAL ( 100 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name INTRON A
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103132 0 6 641986 10 MIUML ( 10 MIUML ) 09232013
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103132 0 7 641986 225 MIU15 ML ( 225 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 8 641986 375 MIU15 ML ( 375 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 9 641986 75 MIU15 ML ( 75 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103949 0 5 1192001 675 MCGPEN ( 675 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 6 1192001 108 MCGPEN ( 108 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
March 2018 Page 6 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name PEGINTRON
103949 0 7 1192001 1184 MCGVIAL ( 1184 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 8 1192001 162 MCGPEN ( 162 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 9 1192001 1776 MCGVIAL ( 1776 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 10 1192001 2025 MCGPEN ( 2025 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 11 1192001 222 MCGVIAL ( 222 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No PALATIN TECHNOLOGIES INC 1588
Trade Name NEUTROSPEC TECHNETIUM (99M TC)
Proper Name FANOLESOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103928 0 1 722004 025 MGVIAL ( 025 MGVIAL ) 09222008
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No RECORDATI RARE DISEASES INC 1899
Trade Name ELSPAR
Proper Name ASPARAGINASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
101063 0 1 1101978 10000 IU ( 10000 IUVIAL ) 04092014
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
March 2018 Page 7 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No SCHERING CORP 0994
Trade Name PEGINTRONREBETOL COMBO PACK
Proper Name PEGINTERFERON ALFA-2B AND RIBAVIRIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125196 0 1 6132008 ( 4 (120 MCG05ML) REDIPEN amp 140 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 2 6132008 ( 4 (150 MCG05ML) REDIPEN amp 168 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 3 6132008 ( 4 (150 MCG05ML) REDIPEN amp 196 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 4 6132008 ( 4 (50 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 5 6132008 ( 4 (80 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125422 0 2 10172012 05 MG ( 25 MGML ) 08082017
SOLUTION INTRAVETREAL SINGLE-DOSE VIAL
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125164 0 10 11142007 50 MCGML ( 50 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 8 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
125164 0 11 11142007 100 MCGML ( 100 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 12 11142007 200 MCGML ( 200 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 13 11142007 300 MCGML ( 300 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 14 11142007 400 MCGML ( 400 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 15 11142007 400 MCG06 ML ( 400 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 16 11142007 600 MCGML ( 600 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 17 11142007 600 MCG06 ML ( 600 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 18 11142007 800 MCG06 ML ( 800 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 19 11142007 1000 MCGML ( 1000 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 9 of 9
CDER Billable Biologic Product List
ApplicantLicense No AMGEN INC 1080
103951 0 8 9172001 25 MCG042 ML ( 25 MCG042 ML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 9 9172001 40 MCG04 ML ( 40 MCG04 ML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 10 9172001 60 MCG03 ML ( 60 MCG03 ML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 11 9172001 100 MCG05 ML ( 100 MCG05 ML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 12 9172001 150 MCG03 ML ( 150 MCG03 ML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 13 9172001 200 MCG04 ML ( 200 MCG04 ML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 14 9172001 300 MCG06 ML ( 300 MCG06 ML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 15 9172001 500 MCGML ( 500 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 31 9172001 10 MCG04 ML ( 10 MCG04 ML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
Trade Name BLINCYTO
Proper Name BLINATUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125557 0 1 1232014 35 MCG ( 35 MCGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name EPOGEN
Proper Name EPOETIN ALFA
March 2018 Page 5 of 42
CDER Billable Biologic Product List
ApplicantLicense No AMGEN INC 1080
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103234 0 6 611989 10000 UML ( 10000 UML )
SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL
103234 0 7 611989 20000 UML ( 10000 UML )
SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL
Proper Name EPOETIN ALFA - PRESERVATIVE FREE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103234 0 1 611989 2000 UML ( 2000 UML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103234 0 2 611989 3000 UML ( 3000 UML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103234 0 3 611989 4000 UML ( 4000 UML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103234 0 4 611989 10000 UML ( 10000 UML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name NEULASTA
Proper Name PEGFILGRASTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125031 0 1 1312002 6 MG06 ML ( 10 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name NEULASTA ONPRO
Proper Name PEGFILGRASTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125031 181 2 9232015 6 MG06 ML ( 10 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name NEUPOGEN
March 2018 Page 6 of 42
CDER Billable Biologic Product List
ApplicantLicense No AMGEN INC 1080
Proper Name FILGRASTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103353 0 1 2201991 300 MCGML ( 300 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103353 0 2 2201991 300 MCG05 ML ( 600 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103353 0 3 2201991 480 MCG16 ML ( 300 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103353 0 4 2201991 480 MCG08 ML ( 600 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
Trade Name NPLATE
Proper Name ROMIPLOSTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125268 0 1 8222008 250 MCG ( 250 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
125268 0 2 8222008 500 MCG ( 500 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name PROCRIT
Proper Name EPOETIN ALFA - PRESERVATIVE FREE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103234 0 5 611989 40000 UML ( 40000 UML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name PROLIA
Proper Name DENOSUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 7 of 42
CDER Billable Biologic Product List
ApplicantLicense No AMGEN INC 1080
125320 0 1 612010 60 MGML ( 60 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name REPATHA
Proper Name EVOLOCUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125522 0 1 8272015 140 MGML ( 140 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125522 1 2 7112016 420 MG35 ML ( 120 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125522 0 3 8272015 140 MGML ( 140 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name VECTIBIX
Proper Name PANITUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125147 0 1 9272006 100 MG5 ML ( 20 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125147 0 2 9272006 200 MG10 ML ( 20 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125147 0 3 9272006 400 MG20 ML ( 20 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name XGEVA
Proper Name DENOSUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125320 7 2 11182010 120 MG17 ML ( 70 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 8 of 42
CDER Billable Biologic Product List
ApplicantLicense No ASTRAZENECA UK LTD 2043
Trade Name FASENRA
Proper Name BENRALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761070 0 1 11142017
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
30 MGML ( 30 MGML )
Trade Name
Proper Name
IMFINZI
DURVALUMAB
BLASTN
761069 0
Product
1
Approval Date
512017
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
120 MG24 ML ( 50 MGML )
761069 0 2 512017
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
500 MG10 ML ( 50 MGML )
ApplicantLicense No AUXILIUM PHARMACEUTICALS INC 1816
Trade Name XIAFLEX
Proper Name CLOSTRIDIAL COLLAGENASE HISTOLYTICUM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125338 0 1 222010 09 MG ( 09 MGVIAL )
POWDER INTRALESIONAL SINGLE-DOSE VIAL
ApplicantLicense No AYTU BIOSCIENCES INC 2035
Trade Name PROSTASCINT
Proper Name CAPROMAB PENDETIDE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103608 0 1 10281996 05 MGML ( 05 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 9 of 42
CDER Billable Biologic Product List
ApplicantLicense No BAXALTA US INC 2020
Trade Name ONCASPAR
Proper Name PEGASPARGASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103411 0 1 211994 3750 IU5 ML ( 750 IUML )
SOLUTION INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No BAYER HEALTHCARE PHARMACEUTICALS INC 1778
Trade Name BETASERON
Proper Name INTERFERON BETA-1B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103471 0 1 7231993 03 MG ( 03 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No BIOGEN INC 1697
Trade Name AVONEX
Proper Name INTERFERON BETA 1A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103628 0 1 5171996
POWDER INTRAMUSCULAR
30 MCG ( 30 MCGVIAL )
SINGLE-DOSE VIAL
103628 0 2 5171996
SOLUTION INTRAMUSCULAR PREFILLED SYRINGE
30 MCG05 ML ( 30 MCG05 ML )
103628 0 3 5171996
SOLUTION INTRAMUSCULAR AUTOINJECTOR
30 MCG05 ML ( 30 MCG05 ML )
Trade Name
Proper Name
BLASTN
125499 0
PLEGRIDY
PEGINTERFERON BETA-1A
Approval Date PotencyDosage FormRoutePresentation Product
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
63 MCG05 ML ( 126 MCGML ) 8152014 1
March 2018 Page 10 of 42
CDER Billable Biologic Product List
ApplicantLicense No BIOGEN INC 1697
125499 0 2 8152014 125 MCG05 ML ( 250 MCGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125499 0 3 8152014 63 MCG05 ML ( 126 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125499 0 4 8152014 94 MCG05 ML ( 188 MCGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125499 0 5 8152014 94 MCG05 ML ( 188 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125499 0 6 8152014 125 MCG05 ML ( 250 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name TYSABRI
Proper Name NATALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125104 0 1 11232004 300 MG15 ML ( 20 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name ZINBRYTA
Proper Name DACLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761029 0 1 5272016 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
761029 0 2 5272016 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 11 of 42
CDER Billable Biologic Product List
ApplicantLicense No BIOMARIN PHARMACEUTICAL INC 1649
Trade Name ALDURAZYME
Proper Name LARONIDASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125058 0 1 4302003
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
29 MG5 ML ( 058 MGML )
Trade Name
Proper Name
BRINEURA
CERLIPONASE ALFA
BLASTN
761052 0
Product
1
Approval Date
4272017
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENTRICULAR SINGLE-DOSE VIAL
150 MG5 ML ( 30 MGML )
Trade Name
Proper Name
NAGLAZYME
GALSULFASE
BLASTN
125117 0
Product
1
Approval Date
5312005
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
5 MG 5ML ( 1 MGML )
Trade Name
Proper Name
VIMIZIM
ELOSULFASE ALFA
BLASTN
125460 0
Product
1
Approval Date
2142014
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
5 MG5 ML ( 1 MGML )
ApplicantLicense No BOEHRINGER INGELHEIM PHARMACEUTICALS INC 2006
Trade Name PRAXBIND
Proper Name IDARUCIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761025 0 1 10162015 2500 MG50 ML ( 50 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 12 of 42
CDER Billable Biologic Product List
ApplicantLicense No BRISTOL MYERS SQUIBB CO 1713
Trade Name EMPLICITI
Proper Name ELOTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761035 0 1 11302015
POWDER INTRAVENOUS SINGLE-DOSE VIAL
300 MG ( 300 MGVIAL )
761035 0 2 11302015
POWDER INTRAVENOUS SINGLE-DOSE VIAL
400 MG ( 400 MGVIAL )
Trade Name
Proper Name
BLASTN
125288 0
NULOJIX
BELATACEPT
Approval Date Product
6152011 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
250 MG ( 250 MGVIAL )
Trade Name
Proper Name
BLASTN
125554 0
OPDIVO
NIVOLUMAB
Approval Date Product
12222014 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
40 MG4 ML ( 10 MGML )
125554 0 2 12222014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG10 ML ( 10 MGML )
125554 0 3 12222014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
240 MG24 ML ( 10 MGML )
Trade Name
Proper Name
BLASTN
125118 0
ORENCIA
ABATACEPT
Approval Date Product
12232005 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
250 MG ( 250 MGVIAL )
March 2018 Page 13 of 42
CDER Billable Biologic Product List
ApplicantLicense No BRISTOL MYERS SQUIBB CO 1713
125118 122 2 7292011 50 MG04 ML ( 125 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125118 122 3 7292011 875 MG07 ML ( 125 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125118 122 4 7292011 125 MGML ( 125 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125118 122 5 7292011 125 MGML ( 125 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name YERVOY
Proper Name IPILIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125377 0 1 3252011 50 MG10 ML ( 5 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125377 0 2 3252011 200 MG40 ML ( 5 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No BTG INTERNATIONAL INC 1861
Trade Name VORAXAZE
Proper Name GLUCARPIDASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125327 0 1 1172012 1000 U ( 1000 UVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 14 of 42
CDER Billable Biologic Product List
ApplicantLicense No DYAX CORPORATION 1789
Trade Name KALBITOR
Proper Name ECALLANTIDE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125277 0 1 1212009 10 MGML ( 10 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No EKR THERAPEUTICS INC 1814
Trade Name RETAVASE
Proper Name RETEPLASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103786 0 1 561998 10 U ( 10 UVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No ELI LILLY AND CO 1891
Trade Name CYRAMZA
Proper Name RAMUCIRUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125477 0 1 4212014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG10 ML ( 10 MGML )
125477 0 2 4212014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
500 MG50 ML ( 10 MGML )
Trade Name
Proper Name
BLASTN
761038 0
LARTRUVO
OLARATUMAB
Approval Date Product
10192016 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
500 MG50 ML ( 10 MGML )
761038 0 2 10192016
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
190 MG19 ML ( 10 MGML )
March 2018 Page 15 of 42
CDER Billable Biologic Product List
ApplicantLicense No ELI LILLY AND CO 1891
Trade Name PORTRAZZA
Proper Name NECITUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125547 0 1 11242015
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
800 MG50 ML ( 16 MGML )
Trade Name
Proper Name
TALTZ
IXEKIZUMAB
BLASTN
125521 0
Product
1
Approval Date
3222016
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
80 MGML ( 80 MGML )
125521 0 2 3222016
SOLUTION SUBCUTANEOUS AUTOINJECTOR
80 MGML ( 80 MGML )
Trade Name
Proper Name
TRULICITY
DULAGLUTIDE
BLASTN
125469 0
Product
1
Approval Date
9182014
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
075 MG05 ML ( 075 MG05 ML )
125469 0 2 9182014
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
15 MG05 ML ( 15 MG05 ML )
125469 0 3 9182014
SOLUTION SUBCUTANEOUS AUTOINJECTOR
075 MG05 ML ( 075 MG05 ML )
125469 0 4 9182014
SOLUTION SUBCUTANEOUS AUTOINJECTOR
15 MG05 ML ( 15 MG05 ML )
March 2018 Page 16 of 42
CDER Billable Biologic Product List
ApplicantLicense No ELUSYS THERAPEUTICS INC 1907
Trade Name ANTHIM
Proper Name OBILTOXAXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125509 1 1 3182016 600 MG6 ML ( 100 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No EMD SERONO INC 1773
Trade Name BAVENCIO
Proper Name AVELUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761049 0 1 3232017
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
200 MG10 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
103780 0
REBIF
INTERFERON BETA 1A
Approval Date Product
372002 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
88 MCG02 ML ( 44 MCGML )
103780 0 2 372002
SOLUTION SUBCUTANEOUS AUTOINJECTOR
88 MCG02 ML ( 44 MCGML )
103780 0 3 372002
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
22 MCG05 ML ( 44 MCGML )
103780 0 4 372002
SOLUTION SUBCUTANEOUS AUTOINJECTOR
22 MCG05 ML ( 44 MCGML )
103780 0 5 372002
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
44 MCG05 ML ( 88 MCGML )
103780 0 6 372002
SOLUTION SUBCUTANEOUS AUTOINJECTOR
44 MCG05 ML ( 88 MCGML )
March 2018 Page 17 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name ACTEMRA
Proper Name TOCILIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125276 0 1 182010
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
80 MG4 ML ( 20 MGML )
125276 0 2 182010
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
200 MG10 ML ( 20 MGML )
125276 0 3 182010
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
400 MG20 ML ( 20 MGML )
BLASTN
125472 1
Product
1
Approval Date
10212013
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
162 MG09 ML ( 179 MGML )
Trade Name
Proper Name
BLASTN
103172 0
ACTIVASE
ALTEPLASE
Approval Date Product
11131987 2
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
50 MG ( 50 MGVIAL )
103172 0 3 11131987
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
BLASTN
125085 0
AVASTIN
BEVACIZUMAB
Approval Date Product
2262004 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG4 ML ( 25 MGML )
125085 0 2 2262004
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
400 MG16 ML ( 25 MGML )
March 2018 Page 18 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name CATHFLO ACTIVASE
Proper Name ALTEPLASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103172 0 1 11131987
POWDER INTRACATHETER SINGLE-DOSE VIAL
2 MG ( 2 MGVIAL )
Trade Name
Proper Name
BLASTN
125486 0
GAZYVA
OBINUYUZUMAB
Approval Date Product
1112013 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1000 MG40 ML ( 25 MGML )
Trade Name
Proper Name
BLASTN
761083 0
HEMLIBRA
EMICIZUMAB-KXWH
Approval Date Product
11162017 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML )
761083 0 2 11162017
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
60 MG04 ML ( 150 MGML )
761083 0 3 11162017
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
105 MG07 ML ( 150 MGML )
761083 0 4 11162017
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
150 MGML ( 150 MGML )
Trade Name
Proper Name
BLASTN
103792 0
HERCEPTIN
TRASTUZUMAB
Approval Date Product
9251998 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS MULTI-DOSE VIAL
420 MG ( 420 MGVIAL )
March 2018 Page 19 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
103792 5336 2 2102017 150 MG ( 150 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name KADCYLA
Proper Name ADO-TRASIUZUMAB EMTANSINE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125427 0 1 2222013
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
125427 0 2 2222013
POWDER INTRAVENOUS SINGLE-DOSE VIAL
160 MG ( 160 MGVIAL )
Trade Name
Proper Name
LUCENTIS
RANIBIZUMAB
BLASTN
125156 0
Product
1
Approval Date
6302006
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE
05 MG005 ML ( 10 MGML )
Proper Name RANIDIZUMAB
BLASTN
125156 076
Product
2
Approval Date
8102012
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE
03 MG005 ML ( 6 MGML )
Trade Name
Proper Name
OCREVUS
OCRELIZUMAB
BLASTN
761053 0
Product
1
Approval Date
3282017
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
300 MG10 ML ( 30 MGML )
Trade Name
Proper Name
PERJETA
PERTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 20 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
125409 0 1 682012 420 MG14 ML ( 30 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name PULMOZYME
Proper Name DORNASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103532 0 1 12301993 25 MG25 ML ( 1 MGML )
SOLUTION INHALATION AMPULE
Trade Name RITUXAN
Proper Name RITUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103705 0 1 11261997 100 MG10 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
103705 0 2 11261997 500 MG50 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name RITUXAN HYCELA
Proper Name RITUXIMAB AND HYALURONIDASE HUMAN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761064 0 1 6222017 1400 MG AND 23400 U117 ML ( 11966 MG AND 2000 UML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
761064 0 2 6222017 1600 MG AND 26800 U134 ML ( 11966 MG AND 2000 UML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name TECENTRIQ
Proper Name ATEZOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761034 0 1 582016 1200 MG20 ML ( 60 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name TNKASE
March 2018 Page 21 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Proper Name TENECTEPLASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103909 0 1 622000 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103976 0 1 6202003 150 MG ( 150 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103948 0 1 572001
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML )
Trade Name
Proper Name
FABRAZYME
AGALSIDASE BETA
BLASTN
103979 0
Product
1
Approval Date
4242003
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
5 MG ( 5 MGVIAL )
103979 0 2 4242003
POWDER INTRAVENOUS SINGLE-DOSE VIAL
35 MG ( 35 MGVIAL )
Trade Name
Proper Name
LEMTRADA
ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 22 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENZYME CORP 1596
103948 5139 2 11142014 12 MG12 ML ( 10MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name LUMIZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125291 0 1 5242010 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name NUCALA
Proper Name MEPOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125526 0 1 11142015
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
TANZEUM
ALBIGLUTIDE
BLASTN
125431 0
Product
1
Approval Date
4152014
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS AUTOINJECTOR
30 MG ( 30 MGAUTOINJECTOR )
125431 0 2 4152014
POWDER SUBCUTANEOUS AUTOINJECTOR
50 MG ( 50 MGAUTOINJECTOR )
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name PEGASYS
Proper Name PEGINTERFERON ALFA 2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103964 5204 4 9292011 180 MCG05 ML ( 360 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 23 of 42
CDER Billable Biologic Product List
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Proper Name PEG-INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103964 0 1 10162002 180 MCGML ( 180 MCGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
103964 0 2 10162002 180 MCG05 ML ( 360 MCGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
103964 5204 3 9292011 135 MCG05 ML ( 270 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
ApplicantLicense No HORIZON PHARMA IRELAND LTD 2022
Trade Name ACTIMMUNE
Proper Name INTERFERON GAMMA-1B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103836 0 1 2251999 100 MCG05 ML ( 200 MCGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No HORIZON PHARMA RHEUMATOLOGY LLC 1998
Trade Name KRYSTEXXA
Proper Name PEGLOTICASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125293 0 1 9142010 8MGML ( 8MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 24 of 42
CDER Billable Biologic Product List
ApplicantLicense No HUMAN GENOME SCIENCES INC 1820
Trade Name BENLYSTA
Proper Name BELIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125370 0 1 392011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
120 MG ( 120 MGVIAL )
125370 0 2 392011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
400 MG ( 400 MGVIAL )
125370 0 3 392011
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )
125370 0 4 392011
SOLUTION SUBCUTANEOUS AUTOINJECTOR
200 MGML ( 200 MGML )
BLASTN
761043 0
Product
1
Approval Date
7202017
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )
Trade Name
Proper Name
RAXIBACUMAB
RAXIBACUMAB
BLASTN
125349 0
Product
1
Approval Date
12142012
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1700 MG34 ML ( 50 MGML )
ApplicantLicense No IMCLONE LLC 1695
Trade Name ERBITUX
Proper Name CETUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125084 0 1 2122004 100 MG50 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 25 of 42
CDER Billable Biologic Product List
ApplicantLicense No IMCLONE LLC 1695
125084 0 2 2122004 200 MG100 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No IMMUNEX CORP 1132
Trade Name ENBREL
Proper Name ETANERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103795 0 1 1121998
POWDER SUBCUTANEOUS MULTI-DOSE VIAL
25 MG ( 25 MGVIAL )
103795 5184 2 9272004
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
50 MGML ( 50 MGML )
103795 0 3 9272004
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MGML ( 50 MGML )
103795 5184 4 9272004
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
25 MG05 ML ( 50 MGML )
103795 5556 5 9142017
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MGML ( 50 MGML )
ApplicantLicense No IPSEN BIOPHARM LIMITED 1787
Trade Name DYSPORT
Proper Name ABOBOTULINUMTOXINA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125274 0 1 4292009
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
300 UNITS ( 300 UNITSVIAL )
125274 0 2 4292009
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
500 UNITS ( 500 UNITSVIAL )
March 2018 Page 26 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
Trade Name DARZALEX
Proper Name DARATUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761036 0 1 11162015
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG5 ML ( 20 MGML )
761036 0 2 11162015
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
400 MG20 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
103772 0
REMICADE
INFLIXIMAB
Approval Date Product
8241998 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
BLASTN
103575 0
REOPRO
ABCIXIMAB
Approval Date Product
12221994 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
10 MG5 ML ( 2 MGML )
Trade Name
Proper Name
BLASTN
125289 0
SIMPONI
GOLIMUMAB
Approval Date Product
4242009 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
50 MG05 ML ( 100 MGML )
125289 0 2 4242009
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MG05 ML ( 100 MGML )
125289 0 3 4242009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
100 MGML ( 100 MGML )
March 2018 Page 27 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
125289 0 4 4242009 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name SIMPONI ARIA
Proper Name GOLIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125433 0 1 7182013 50 MG4 ML ( 125 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name STELARA
Proper Name USTEKINUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125261 0 1 9252009 90 MGML ( 90 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125261 0 2 9252009 45 MG05 ML ( 90 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL amp PREFILLED SYRINGE
125261 0 3 9252009 130 MG26 ML ( 5 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761044 0 1 9232016 130 MG26 ML ( 5 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SYLVANT
Proper Name SILTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125496 0 1 4232014 100 MG ( 100 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125496 0 2 4232014 400 MG ( 400 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 28 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
Trade Name TREMFYA
Proper Name GUSELKUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761061 0 1 7132017 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No JAZZ PHARMACEUTICALS INC 1901
Trade Name ERWINAZE
Proper Name ASPARAGINASE ERWINIA CHRYSANTHEMI
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
105359 0 1 11182011 10000 IU ( 10000 IUVIAL )
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103770 0 1 6191998
SOLUTION INTRAMUSCULAR
50 MG05 ML ( 100 MGML )
SINGLE-DOSE VIAL
103770 0 2 6191998
SOLUTION INTRAMUSCULAR
100 MGML ( 100 MGML )
SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name ILUMYA
Proper Name TILDRAKIZUMAB-ASMN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761067 0 1 3202018 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name INTRON A
March 2018 Page 29 of 42
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103132 0 1 641986 10 MIU ( 10 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL INTRAVENOUS SINGLE-DOSE VIAL
103132 0 2 641986 18 MIU ( 18 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL
103132 0 3 641986 50 MIU ( 50 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL
103132 0 4 641986 228 MIU38 ML ( 6 MIUML )
SOLUTION INTRAMUSCULAR SUBCUTANEOUS MULTI-DOSE VIAL
103132 0 5 641986 32 MIU32 ML ( 10 MIUML )
SOLUTION INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL MULTI-DOSE VIAL
Trade Name KEYTRUDA
Proper Name PEMBROLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125514 0 1 942014 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125514 1 2 1152015 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 0 1 1192001 74 MCG ( 74 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SYLATRON
Proper Name PEGINTERFERON ALFA-2B
March 2018 Page 30 of 42
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 5153 2 3292011 296 MCG ( 296 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 3 3292011 444 MCG ( 444 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 4 3292011 888 MCG ( 888 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name ZINPLAVA
Proper Name BEZLOTOXUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761046 0 1 10212016 1000 MG40 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No MERZ PHARMACEUTICALS GMBH 1830
Trade Name XEOMIN
Proper Name INCOBOTULINUMTOXINA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125360 0 1 7302010
POWDER INTRAMUSCULAR
50 U ( 50 UVIAL )
SINGLE-DOSE VIAL
125360 0 2 7302010
POWDER INTRAMUSCULAR
100 U ( 100 UVIAL )
SINGLE-DOSE VIAL
125360 3 3 11202015
POWDER INTRAMUSCULAR
200 U ( 200 UVIAL )
SINGLE-DOSE VIAL
March 2018 Page 31 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
Trade Name ARZERRA
Proper Name OFATUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125326 0 1 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG5 ML ( 20 MGML )
125326 0 2 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1000 MG50 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
125504 0
COSENTYX
SECUKINUMAB
Approval Date Product
1212015 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
150 MG ( 150 MGVIAL )
125504 0 2 1212015
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MGML ( 150 MGML )
125504 0 3 1212015
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MGML ( 150 MGML )
Trade Name
Proper Name
BLASTN
125290 0
EXTAVIA
INTERFERON BETA-1B
Approval Date Product
8142009 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
03 MG ( 03 MGVIAL )
Trade Name
Proper Name
BLASTN
125319 0
ILARIS
CANAKINUMAB
Approval Date Product
6172009 1
PotencyDosage FormRoutePresentation
180 MGVIAL ( 180 MGVIAL )
March 2018 Page 32 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
125319 88 2 12222016 150 MG ( 150 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
125319 0 3 12222016 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SIMULECT
Proper Name BASILIXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103764 0 1 5121998 10 MG ( 10 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
103764 0 2 5121998 20 MG ( 20 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No NPS PHARMACEUTICALS INC 1908
Trade Name NATPARA
Proper Name PARATHYROID HORMONE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 33 of 42
CDER Billable Biologic Product List
ApplicantLicense No PROMETHEUS LABORATORIES INC 1848
Trade Name PROLEUKIN
Proper Name ALDESLEUKIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103293 0 1 551992 22 MIU ( 22 MIUVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760
Trade Name ARCALYST
Proper Name RILONACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125249 0 1 2272008
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
220MG ( 220MGVIAL )
Trade Name
Proper Name
DUPIXENT
DUPILUMAB
BLASTN
761055 0
Product
1
Approval Date
3282017
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
300 MG2 ML ( 150 MGML )
Trade Name
Proper Name
EYLEA
AFLIBERCEPT
BLASTN
125387 0
Product
1
Approval Date
11182011
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
2 MG005 ML ( 40 MGML )
March 2018 Page 34 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Trade Name ELITEK
Proper Name RASBURICASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103946 0 1 7122002
POWDER INTRAVENOUS SINGLE-DOSE VIAL
15 MG ( 15 MGVIAL )
103946 5020 2 162006
POWDER INTRAVENOUS SINGLE-DOSE VIAL
75 MG ( 75 MGVIAL )
Trade Name
Proper Name
BLASTN
761037 0
KEVZARA
SARILUMAB
Approval Date Product
5222017 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MG114 ML ( 13158 MGML )
761037 0 2 5222017
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MG114 ML ( 17544 MGML )
761037 1 3 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MG114 ML ( 13158 MGML )
761037 1 4 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
200 MG114 ML ( 17544 MGML )
Trade Name
Proper Name
BLASTN
103362 0
LEUKINE
SARGRAMOSTIM
Approval Date Product
351991 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
250 MCG ( 250 MCGVIAL )
103362 0 2 351991
SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL
500 MCGML ( 500 MCGML )
Trade Name PRALUENT
March 2018 Page 35 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Proper Name ALIROCUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125559 0 1 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 2 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 3 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125559 0 4 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name ZALTRAP
Proper Name ZIV-AFLIBERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125418 0 1 832012 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125418 0 2 832012 200 MG8 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SEATTLE GENETICS INC 1853
Trade Name ADCETRIS
Proper Name BRENTUXIMAB VEDOTIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125388 1 1 8192011 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 36 of 42
CDER Billable Biologic Product List
ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593
Trade Name ELAPRASE
Proper Name IDURSULFASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125151 0 1 7242006 6 MG3 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SICOR BIOTECH UAB 1803
Trade Name GRANIX
Proper Name TBO-FILGRASTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125294 0 1 8292012
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
300 MCG0 5 ML ( 600 MCGML )
125294 0 2 8292012
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
480 MCG08 ML ( 600 MCGML )
ApplicantLicense No SMITH AND NEPHEW INC 2004
Trade Name REGRANEX
Proper Name BECAPLERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103691 0 1 12161997
GEL TOPICAL
100 UG ( 100 UGGM )
Trade Name
Proper Name
SANTYL
COLLAGENASE
BLASTN
101995 0
Product
1
Approval Date
641965
PotencyDosage FormRoutePresentation
OINTMENT TOPICAL
30 G amp 90 G TUBE ( 250 UGRAM )
March 2018 Page 37 of 42
CDER Billable Biologic Product List
ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718
Trade Name MYOBLOC
Proper Name RIMABOTULINUM TOXIN B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103846 0 1 1282002
SOLUTION INTRAMUSCULAR
2500 IU05 ML ( 5000 IUML )
SINGLE-DOSE VIAL
103846 0 3 1282002
SOLUTION INTRAMUSCULAR
10000 IU2 ML ( 5000 IUML )
SINGLE-DOSE VIAL
Proper Name RIMABOTULINUMTOXINB
BLASTN
103846 0
Product
2
Approval Date
1282002
PotencyDosage FormRoutePresentation
SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL
5000 IUML ( 5000 IUML )
ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832
Trade Name ZEVALIN
Proper Name IBRITUMOMAB TIUXETAN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125019 0 1 2192002 32 MG2 ML ( 16 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
Trade Name KEPIVANCE
Proper Name PALIFERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125103 0 1 12152004 625 MG ( 625 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name KINERET
Proper Name ANAKINRA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 38 of 42
CDER Billable Biologic Product List
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898
Trade Name ENTYVIO
Proper Name VEDOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125476 0 1 5202014 300 MG ( 300 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No TEVA RESPIRATORY LLC 2047
Trade Name CINQAIR
Proper Name RESLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761033 0 1 3232016 100 MG10 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No THERATECHNOLOGIES INC 2091
Trade Name TROGARZO
Proper Name IBALIZUMAB-UIYK
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761065 0 1 362018 200 MG133 ML ( 150 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 39 of 42
CDER Billable Biologic Product List
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
0375 MG03 ML ( 125 MGML )2222017 125422 038 1
ApplicantLicense No UCB INC 1736
Trade Name CIMZIA
Proper Name CERTOLIZUMAB PEGOL
BLASTN Approval Date PotencyDosage FormRoutePresentation Product
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
200 MG ( 200 MGVIAL ) 4222008 125160 0 1
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )5132009 125160 080 2
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
Trade Name CRYSVITA
Proper Name BUROSUMAB-TWZA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761068 0 1 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
10 MGML ( 10 MGML )
761068 0 2 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
20 MGML ( 20 MGML )
761068 0
Trade Name
Proper Name
BLASTN
March 2018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML ) 4172018 3
MEPSEVII
VESTRONIDASE ALFA-VJBK
Approval Date PotencyDosage FormRoutePresentation Product
Page 40 of 42
CDER Billable Biologic Product List
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
761047 0 1 11152017 10 MG5 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No UNITED THERAPEUTICS CORP 1993
Trade Name UNITUXIN
Proper Name DINUTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125516 0 1 3102015 175 MG5 ML ( 35 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053
Trade Name SILIQ
Proper Name BRODALUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761032 0 1 2152017 210 MG15 ML ( 140 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 41 of 42
CDER Billable Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No WYETH PHARMACEUTICALS INC 0003
Trade Name BESPONSA
Proper Name INOTUZUMAB OZOGAMICIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761040 0 1 8172017 09 MG ( 09 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 42 of 42
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 1 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
9172001 103951 0 26
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
200 MCGML ( 200 MCGML ) 09272012
103951 0 27 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
200 MCG04 ML ( 500 MCGML ) 09272012
103951 0 28 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
300 MCGML ( 300 MCGML ) 09272012
103951 0 29 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
300 MCG06 ML ( 500 MCGML ) 09272012
103951 0 30 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
500 MCGML ( 500 MCGML ) 09272012
ApplicantLicense No ASTELLAS PHARMACEUTICALS US INC 1748
Trade Name AMEVIVE
Proper Name ALEFACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125036 0 1 1302003 75 MGVIAL ( 75 MGVIAL ) 09242008
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
125036 0 2 1302003 15 MGVIAL ( 15 MGVIAL ) 09282012
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No BOEHRINGER INGELHEIM PHARMA KG 1251
Trade Name VERLUMA
Proper Name NOFETUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103769 0 1 10131998 10 MGML ( 10 MGML ) 08132013
INTRAVENOUS
March 2018 Page 2 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No CENTOCOR ORTHO BIOTECH PRODUCTS LP 1824
Trade Name ORTHOCLONE OKT3
Proper Name MUROMONAB-CD3
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103463 0 1 9141992 1 MGML ( 1 MGML ) 01112012
SOLUTION INTRAVENOUS AMPULE
ApplicantLicense No EISAI INCORPORATED 1862
Trade Name ONTAK
Proper Name DENILEUKIN DIFTITOX
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103767 0 1 251999 300 MCG2 ML ( 150 MCGML ) 01302014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No ELI LILLY AND CO 1611
Trade Name XIGRIS
Proper Name DROTRECOGIN ALFA (ACTIVATED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125029 0 1 11212001 5 MGVIAL ( 5 MGVIAL ) 10262011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125029 0 2 11212001 20 MGVIAL ( 20 MGVIAL ) 10102011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GENENTECH INC 1048
Trade Name RAPTIVA
Proper Name EFALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125075 0 1 10272003 125 MGVIAL ( 125 MGVIAL ) 09012009
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
March 2018 Page 3 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103976 0 2 6202003 125 MGVIAL ( 125 MGVIAL ) 08252016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103948 0 3 572001 10 MGVIAL ( 10 MGVIAL ) 07062011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name MYOZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125141 0 1 4282006 50 MGVIAL ( 50 MGVIAL ) 10172014
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name BEXXAR THERAPEUTIC REGIME
Proper Name TOSITUMOMAB AND IODINE I-131 TOSITUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125011 0 1 6272003 01 MGML I-131 TOSITUMOMAB ( 01 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 2 6272003 11 MGML I-131 TOSITUMOMAB ( 11 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 3 6272003 14 MGML TOSITUMOMAB ( 14 MGML 03102014 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 4 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No HEMISPHERX BIOPHARMA INC 1703
Trade Name ALFERON N INJECTION
Proper Name INTERFERON ALFA-N3 (HUMAN LEUKOCYTE DERIVED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103158 0 1 10101989 5 MIUVIAL ( 5 MIUVIAL ) 06272013
SOLUTION INTRALESIONAL MULTI-DOSE VIAL
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name ROFERON A
Proper Name INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103145 0 1 641986 3 MIU05 ML ( 3 MIU05 ML ) 06012009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name ZENAPAX
Proper Name DACLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103749 0 1 12101997 25 MG5 ML ( 25 MG5 ML ) 07072011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No KADMON PHARMACEUTICALS LLC 1867
Trade Name INFERGEN
Proper Name INTERFERON ALFACON-1
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103663 0 1 1061997 9 MCG03 ML ( 30 MCGML ) 07252013
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 5 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103770 0 3 6191998 50 MGVIAL ( 50 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
103770 0 4 6191998 100 MGVIAL ( 100 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name INTRON A
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103132 0 6 641986 10 MIUML ( 10 MIUML ) 09232013
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103132 0 7 641986 225 MIU15 ML ( 225 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 8 641986 375 MIU15 ML ( 375 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 9 641986 75 MIU15 ML ( 75 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103949 0 5 1192001 675 MCGPEN ( 675 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 6 1192001 108 MCGPEN ( 108 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
March 2018 Page 6 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name PEGINTRON
103949 0 7 1192001 1184 MCGVIAL ( 1184 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 8 1192001 162 MCGPEN ( 162 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 9 1192001 1776 MCGVIAL ( 1776 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 10 1192001 2025 MCGPEN ( 2025 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 11 1192001 222 MCGVIAL ( 222 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No PALATIN TECHNOLOGIES INC 1588
Trade Name NEUTROSPEC TECHNETIUM (99M TC)
Proper Name FANOLESOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103928 0 1 722004 025 MGVIAL ( 025 MGVIAL ) 09222008
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No RECORDATI RARE DISEASES INC 1899
Trade Name ELSPAR
Proper Name ASPARAGINASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
101063 0 1 1101978 10000 IU ( 10000 IUVIAL ) 04092014
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
March 2018 Page 7 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No SCHERING CORP 0994
Trade Name PEGINTRONREBETOL COMBO PACK
Proper Name PEGINTERFERON ALFA-2B AND RIBAVIRIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125196 0 1 6132008 ( 4 (120 MCG05ML) REDIPEN amp 140 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 2 6132008 ( 4 (150 MCG05ML) REDIPEN amp 168 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 3 6132008 ( 4 (150 MCG05ML) REDIPEN amp 196 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 4 6132008 ( 4 (50 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 5 6132008 ( 4 (80 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125422 0 2 10172012 05 MG ( 25 MGML ) 08082017
SOLUTION INTRAVETREAL SINGLE-DOSE VIAL
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125164 0 10 11142007 50 MCGML ( 50 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 8 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
125164 0 11 11142007 100 MCGML ( 100 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 12 11142007 200 MCGML ( 200 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 13 11142007 300 MCGML ( 300 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 14 11142007 400 MCGML ( 400 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 15 11142007 400 MCG06 ML ( 400 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 16 11142007 600 MCGML ( 600 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 17 11142007 600 MCG06 ML ( 600 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 18 11142007 800 MCG06 ML ( 800 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 19 11142007 1000 MCGML ( 1000 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 9 of 9
CDER Billable Biologic Product List
ApplicantLicense No AMGEN INC 1080
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103234 0 6 611989 10000 UML ( 10000 UML )
SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL
103234 0 7 611989 20000 UML ( 10000 UML )
SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL
Proper Name EPOETIN ALFA - PRESERVATIVE FREE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103234 0 1 611989 2000 UML ( 2000 UML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103234 0 2 611989 3000 UML ( 3000 UML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103234 0 3 611989 4000 UML ( 4000 UML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103234 0 4 611989 10000 UML ( 10000 UML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name NEULASTA
Proper Name PEGFILGRASTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125031 0 1 1312002 6 MG06 ML ( 10 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name NEULASTA ONPRO
Proper Name PEGFILGRASTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125031 181 2 9232015 6 MG06 ML ( 10 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name NEUPOGEN
March 2018 Page 6 of 42
CDER Billable Biologic Product List
ApplicantLicense No AMGEN INC 1080
Proper Name FILGRASTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103353 0 1 2201991 300 MCGML ( 300 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103353 0 2 2201991 300 MCG05 ML ( 600 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103353 0 3 2201991 480 MCG16 ML ( 300 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103353 0 4 2201991 480 MCG08 ML ( 600 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
Trade Name NPLATE
Proper Name ROMIPLOSTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125268 0 1 8222008 250 MCG ( 250 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
125268 0 2 8222008 500 MCG ( 500 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name PROCRIT
Proper Name EPOETIN ALFA - PRESERVATIVE FREE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103234 0 5 611989 40000 UML ( 40000 UML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name PROLIA
Proper Name DENOSUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 7 of 42
CDER Billable Biologic Product List
ApplicantLicense No AMGEN INC 1080
125320 0 1 612010 60 MGML ( 60 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name REPATHA
Proper Name EVOLOCUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125522 0 1 8272015 140 MGML ( 140 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125522 1 2 7112016 420 MG35 ML ( 120 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125522 0 3 8272015 140 MGML ( 140 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name VECTIBIX
Proper Name PANITUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125147 0 1 9272006 100 MG5 ML ( 20 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125147 0 2 9272006 200 MG10 ML ( 20 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125147 0 3 9272006 400 MG20 ML ( 20 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name XGEVA
Proper Name DENOSUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125320 7 2 11182010 120 MG17 ML ( 70 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 8 of 42
CDER Billable Biologic Product List
ApplicantLicense No ASTRAZENECA UK LTD 2043
Trade Name FASENRA
Proper Name BENRALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761070 0 1 11142017
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
30 MGML ( 30 MGML )
Trade Name
Proper Name
IMFINZI
DURVALUMAB
BLASTN
761069 0
Product
1
Approval Date
512017
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
120 MG24 ML ( 50 MGML )
761069 0 2 512017
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
500 MG10 ML ( 50 MGML )
ApplicantLicense No AUXILIUM PHARMACEUTICALS INC 1816
Trade Name XIAFLEX
Proper Name CLOSTRIDIAL COLLAGENASE HISTOLYTICUM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125338 0 1 222010 09 MG ( 09 MGVIAL )
POWDER INTRALESIONAL SINGLE-DOSE VIAL
ApplicantLicense No AYTU BIOSCIENCES INC 2035
Trade Name PROSTASCINT
Proper Name CAPROMAB PENDETIDE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103608 0 1 10281996 05 MGML ( 05 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 9 of 42
CDER Billable Biologic Product List
ApplicantLicense No BAXALTA US INC 2020
Trade Name ONCASPAR
Proper Name PEGASPARGASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103411 0 1 211994 3750 IU5 ML ( 750 IUML )
SOLUTION INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No BAYER HEALTHCARE PHARMACEUTICALS INC 1778
Trade Name BETASERON
Proper Name INTERFERON BETA-1B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103471 0 1 7231993 03 MG ( 03 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No BIOGEN INC 1697
Trade Name AVONEX
Proper Name INTERFERON BETA 1A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103628 0 1 5171996
POWDER INTRAMUSCULAR
30 MCG ( 30 MCGVIAL )
SINGLE-DOSE VIAL
103628 0 2 5171996
SOLUTION INTRAMUSCULAR PREFILLED SYRINGE
30 MCG05 ML ( 30 MCG05 ML )
103628 0 3 5171996
SOLUTION INTRAMUSCULAR AUTOINJECTOR
30 MCG05 ML ( 30 MCG05 ML )
Trade Name
Proper Name
BLASTN
125499 0
PLEGRIDY
PEGINTERFERON BETA-1A
Approval Date PotencyDosage FormRoutePresentation Product
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
63 MCG05 ML ( 126 MCGML ) 8152014 1
March 2018 Page 10 of 42
CDER Billable Biologic Product List
ApplicantLicense No BIOGEN INC 1697
125499 0 2 8152014 125 MCG05 ML ( 250 MCGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125499 0 3 8152014 63 MCG05 ML ( 126 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125499 0 4 8152014 94 MCG05 ML ( 188 MCGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125499 0 5 8152014 94 MCG05 ML ( 188 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125499 0 6 8152014 125 MCG05 ML ( 250 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name TYSABRI
Proper Name NATALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125104 0 1 11232004 300 MG15 ML ( 20 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name ZINBRYTA
Proper Name DACLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761029 0 1 5272016 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
761029 0 2 5272016 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 11 of 42
CDER Billable Biologic Product List
ApplicantLicense No BIOMARIN PHARMACEUTICAL INC 1649
Trade Name ALDURAZYME
Proper Name LARONIDASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125058 0 1 4302003
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
29 MG5 ML ( 058 MGML )
Trade Name
Proper Name
BRINEURA
CERLIPONASE ALFA
BLASTN
761052 0
Product
1
Approval Date
4272017
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENTRICULAR SINGLE-DOSE VIAL
150 MG5 ML ( 30 MGML )
Trade Name
Proper Name
NAGLAZYME
GALSULFASE
BLASTN
125117 0
Product
1
Approval Date
5312005
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
5 MG 5ML ( 1 MGML )
Trade Name
Proper Name
VIMIZIM
ELOSULFASE ALFA
BLASTN
125460 0
Product
1
Approval Date
2142014
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
5 MG5 ML ( 1 MGML )
ApplicantLicense No BOEHRINGER INGELHEIM PHARMACEUTICALS INC 2006
Trade Name PRAXBIND
Proper Name IDARUCIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761025 0 1 10162015 2500 MG50 ML ( 50 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 12 of 42
CDER Billable Biologic Product List
ApplicantLicense No BRISTOL MYERS SQUIBB CO 1713
Trade Name EMPLICITI
Proper Name ELOTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761035 0 1 11302015
POWDER INTRAVENOUS SINGLE-DOSE VIAL
300 MG ( 300 MGVIAL )
761035 0 2 11302015
POWDER INTRAVENOUS SINGLE-DOSE VIAL
400 MG ( 400 MGVIAL )
Trade Name
Proper Name
BLASTN
125288 0
NULOJIX
BELATACEPT
Approval Date Product
6152011 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
250 MG ( 250 MGVIAL )
Trade Name
Proper Name
BLASTN
125554 0
OPDIVO
NIVOLUMAB
Approval Date Product
12222014 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
40 MG4 ML ( 10 MGML )
125554 0 2 12222014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG10 ML ( 10 MGML )
125554 0 3 12222014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
240 MG24 ML ( 10 MGML )
Trade Name
Proper Name
BLASTN
125118 0
ORENCIA
ABATACEPT
Approval Date Product
12232005 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
250 MG ( 250 MGVIAL )
March 2018 Page 13 of 42
CDER Billable Biologic Product List
ApplicantLicense No BRISTOL MYERS SQUIBB CO 1713
125118 122 2 7292011 50 MG04 ML ( 125 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125118 122 3 7292011 875 MG07 ML ( 125 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125118 122 4 7292011 125 MGML ( 125 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125118 122 5 7292011 125 MGML ( 125 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name YERVOY
Proper Name IPILIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125377 0 1 3252011 50 MG10 ML ( 5 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125377 0 2 3252011 200 MG40 ML ( 5 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No BTG INTERNATIONAL INC 1861
Trade Name VORAXAZE
Proper Name GLUCARPIDASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125327 0 1 1172012 1000 U ( 1000 UVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 14 of 42
CDER Billable Biologic Product List
ApplicantLicense No DYAX CORPORATION 1789
Trade Name KALBITOR
Proper Name ECALLANTIDE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125277 0 1 1212009 10 MGML ( 10 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No EKR THERAPEUTICS INC 1814
Trade Name RETAVASE
Proper Name RETEPLASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103786 0 1 561998 10 U ( 10 UVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No ELI LILLY AND CO 1891
Trade Name CYRAMZA
Proper Name RAMUCIRUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125477 0 1 4212014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG10 ML ( 10 MGML )
125477 0 2 4212014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
500 MG50 ML ( 10 MGML )
Trade Name
Proper Name
BLASTN
761038 0
LARTRUVO
OLARATUMAB
Approval Date Product
10192016 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
500 MG50 ML ( 10 MGML )
761038 0 2 10192016
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
190 MG19 ML ( 10 MGML )
March 2018 Page 15 of 42
CDER Billable Biologic Product List
ApplicantLicense No ELI LILLY AND CO 1891
Trade Name PORTRAZZA
Proper Name NECITUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125547 0 1 11242015
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
800 MG50 ML ( 16 MGML )
Trade Name
Proper Name
TALTZ
IXEKIZUMAB
BLASTN
125521 0
Product
1
Approval Date
3222016
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
80 MGML ( 80 MGML )
125521 0 2 3222016
SOLUTION SUBCUTANEOUS AUTOINJECTOR
80 MGML ( 80 MGML )
Trade Name
Proper Name
TRULICITY
DULAGLUTIDE
BLASTN
125469 0
Product
1
Approval Date
9182014
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
075 MG05 ML ( 075 MG05 ML )
125469 0 2 9182014
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
15 MG05 ML ( 15 MG05 ML )
125469 0 3 9182014
SOLUTION SUBCUTANEOUS AUTOINJECTOR
075 MG05 ML ( 075 MG05 ML )
125469 0 4 9182014
SOLUTION SUBCUTANEOUS AUTOINJECTOR
15 MG05 ML ( 15 MG05 ML )
March 2018 Page 16 of 42
CDER Billable Biologic Product List
ApplicantLicense No ELUSYS THERAPEUTICS INC 1907
Trade Name ANTHIM
Proper Name OBILTOXAXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125509 1 1 3182016 600 MG6 ML ( 100 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No EMD SERONO INC 1773
Trade Name BAVENCIO
Proper Name AVELUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761049 0 1 3232017
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
200 MG10 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
103780 0
REBIF
INTERFERON BETA 1A
Approval Date Product
372002 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
88 MCG02 ML ( 44 MCGML )
103780 0 2 372002
SOLUTION SUBCUTANEOUS AUTOINJECTOR
88 MCG02 ML ( 44 MCGML )
103780 0 3 372002
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
22 MCG05 ML ( 44 MCGML )
103780 0 4 372002
SOLUTION SUBCUTANEOUS AUTOINJECTOR
22 MCG05 ML ( 44 MCGML )
103780 0 5 372002
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
44 MCG05 ML ( 88 MCGML )
103780 0 6 372002
SOLUTION SUBCUTANEOUS AUTOINJECTOR
44 MCG05 ML ( 88 MCGML )
March 2018 Page 17 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name ACTEMRA
Proper Name TOCILIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125276 0 1 182010
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
80 MG4 ML ( 20 MGML )
125276 0 2 182010
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
200 MG10 ML ( 20 MGML )
125276 0 3 182010
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
400 MG20 ML ( 20 MGML )
BLASTN
125472 1
Product
1
Approval Date
10212013
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
162 MG09 ML ( 179 MGML )
Trade Name
Proper Name
BLASTN
103172 0
ACTIVASE
ALTEPLASE
Approval Date Product
11131987 2
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
50 MG ( 50 MGVIAL )
103172 0 3 11131987
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
BLASTN
125085 0
AVASTIN
BEVACIZUMAB
Approval Date Product
2262004 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG4 ML ( 25 MGML )
125085 0 2 2262004
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
400 MG16 ML ( 25 MGML )
March 2018 Page 18 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name CATHFLO ACTIVASE
Proper Name ALTEPLASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103172 0 1 11131987
POWDER INTRACATHETER SINGLE-DOSE VIAL
2 MG ( 2 MGVIAL )
Trade Name
Proper Name
BLASTN
125486 0
GAZYVA
OBINUYUZUMAB
Approval Date Product
1112013 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1000 MG40 ML ( 25 MGML )
Trade Name
Proper Name
BLASTN
761083 0
HEMLIBRA
EMICIZUMAB-KXWH
Approval Date Product
11162017 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML )
761083 0 2 11162017
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
60 MG04 ML ( 150 MGML )
761083 0 3 11162017
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
105 MG07 ML ( 150 MGML )
761083 0 4 11162017
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
150 MGML ( 150 MGML )
Trade Name
Proper Name
BLASTN
103792 0
HERCEPTIN
TRASTUZUMAB
Approval Date Product
9251998 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS MULTI-DOSE VIAL
420 MG ( 420 MGVIAL )
March 2018 Page 19 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
103792 5336 2 2102017 150 MG ( 150 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name KADCYLA
Proper Name ADO-TRASIUZUMAB EMTANSINE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125427 0 1 2222013
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
125427 0 2 2222013
POWDER INTRAVENOUS SINGLE-DOSE VIAL
160 MG ( 160 MGVIAL )
Trade Name
Proper Name
LUCENTIS
RANIBIZUMAB
BLASTN
125156 0
Product
1
Approval Date
6302006
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE
05 MG005 ML ( 10 MGML )
Proper Name RANIDIZUMAB
BLASTN
125156 076
Product
2
Approval Date
8102012
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE
03 MG005 ML ( 6 MGML )
Trade Name
Proper Name
OCREVUS
OCRELIZUMAB
BLASTN
761053 0
Product
1
Approval Date
3282017
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
300 MG10 ML ( 30 MGML )
Trade Name
Proper Name
PERJETA
PERTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 20 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
125409 0 1 682012 420 MG14 ML ( 30 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name PULMOZYME
Proper Name DORNASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103532 0 1 12301993 25 MG25 ML ( 1 MGML )
SOLUTION INHALATION AMPULE
Trade Name RITUXAN
Proper Name RITUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103705 0 1 11261997 100 MG10 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
103705 0 2 11261997 500 MG50 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name RITUXAN HYCELA
Proper Name RITUXIMAB AND HYALURONIDASE HUMAN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761064 0 1 6222017 1400 MG AND 23400 U117 ML ( 11966 MG AND 2000 UML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
761064 0 2 6222017 1600 MG AND 26800 U134 ML ( 11966 MG AND 2000 UML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name TECENTRIQ
Proper Name ATEZOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761034 0 1 582016 1200 MG20 ML ( 60 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name TNKASE
March 2018 Page 21 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Proper Name TENECTEPLASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103909 0 1 622000 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103976 0 1 6202003 150 MG ( 150 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103948 0 1 572001
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML )
Trade Name
Proper Name
FABRAZYME
AGALSIDASE BETA
BLASTN
103979 0
Product
1
Approval Date
4242003
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
5 MG ( 5 MGVIAL )
103979 0 2 4242003
POWDER INTRAVENOUS SINGLE-DOSE VIAL
35 MG ( 35 MGVIAL )
Trade Name
Proper Name
LEMTRADA
ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 22 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENZYME CORP 1596
103948 5139 2 11142014 12 MG12 ML ( 10MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name LUMIZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125291 0 1 5242010 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name NUCALA
Proper Name MEPOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125526 0 1 11142015
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
TANZEUM
ALBIGLUTIDE
BLASTN
125431 0
Product
1
Approval Date
4152014
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS AUTOINJECTOR
30 MG ( 30 MGAUTOINJECTOR )
125431 0 2 4152014
POWDER SUBCUTANEOUS AUTOINJECTOR
50 MG ( 50 MGAUTOINJECTOR )
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name PEGASYS
Proper Name PEGINTERFERON ALFA 2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103964 5204 4 9292011 180 MCG05 ML ( 360 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 23 of 42
CDER Billable Biologic Product List
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Proper Name PEG-INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103964 0 1 10162002 180 MCGML ( 180 MCGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
103964 0 2 10162002 180 MCG05 ML ( 360 MCGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
103964 5204 3 9292011 135 MCG05 ML ( 270 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
ApplicantLicense No HORIZON PHARMA IRELAND LTD 2022
Trade Name ACTIMMUNE
Proper Name INTERFERON GAMMA-1B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103836 0 1 2251999 100 MCG05 ML ( 200 MCGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No HORIZON PHARMA RHEUMATOLOGY LLC 1998
Trade Name KRYSTEXXA
Proper Name PEGLOTICASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125293 0 1 9142010 8MGML ( 8MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 24 of 42
CDER Billable Biologic Product List
ApplicantLicense No HUMAN GENOME SCIENCES INC 1820
Trade Name BENLYSTA
Proper Name BELIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125370 0 1 392011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
120 MG ( 120 MGVIAL )
125370 0 2 392011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
400 MG ( 400 MGVIAL )
125370 0 3 392011
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )
125370 0 4 392011
SOLUTION SUBCUTANEOUS AUTOINJECTOR
200 MGML ( 200 MGML )
BLASTN
761043 0
Product
1
Approval Date
7202017
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )
Trade Name
Proper Name
RAXIBACUMAB
RAXIBACUMAB
BLASTN
125349 0
Product
1
Approval Date
12142012
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1700 MG34 ML ( 50 MGML )
ApplicantLicense No IMCLONE LLC 1695
Trade Name ERBITUX
Proper Name CETUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125084 0 1 2122004 100 MG50 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 25 of 42
CDER Billable Biologic Product List
ApplicantLicense No IMCLONE LLC 1695
125084 0 2 2122004 200 MG100 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No IMMUNEX CORP 1132
Trade Name ENBREL
Proper Name ETANERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103795 0 1 1121998
POWDER SUBCUTANEOUS MULTI-DOSE VIAL
25 MG ( 25 MGVIAL )
103795 5184 2 9272004
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
50 MGML ( 50 MGML )
103795 0 3 9272004
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MGML ( 50 MGML )
103795 5184 4 9272004
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
25 MG05 ML ( 50 MGML )
103795 5556 5 9142017
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MGML ( 50 MGML )
ApplicantLicense No IPSEN BIOPHARM LIMITED 1787
Trade Name DYSPORT
Proper Name ABOBOTULINUMTOXINA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125274 0 1 4292009
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
300 UNITS ( 300 UNITSVIAL )
125274 0 2 4292009
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
500 UNITS ( 500 UNITSVIAL )
March 2018 Page 26 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
Trade Name DARZALEX
Proper Name DARATUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761036 0 1 11162015
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG5 ML ( 20 MGML )
761036 0 2 11162015
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
400 MG20 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
103772 0
REMICADE
INFLIXIMAB
Approval Date Product
8241998 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
BLASTN
103575 0
REOPRO
ABCIXIMAB
Approval Date Product
12221994 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
10 MG5 ML ( 2 MGML )
Trade Name
Proper Name
BLASTN
125289 0
SIMPONI
GOLIMUMAB
Approval Date Product
4242009 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
50 MG05 ML ( 100 MGML )
125289 0 2 4242009
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MG05 ML ( 100 MGML )
125289 0 3 4242009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
100 MGML ( 100 MGML )
March 2018 Page 27 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
125289 0 4 4242009 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name SIMPONI ARIA
Proper Name GOLIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125433 0 1 7182013 50 MG4 ML ( 125 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name STELARA
Proper Name USTEKINUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125261 0 1 9252009 90 MGML ( 90 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125261 0 2 9252009 45 MG05 ML ( 90 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL amp PREFILLED SYRINGE
125261 0 3 9252009 130 MG26 ML ( 5 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761044 0 1 9232016 130 MG26 ML ( 5 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SYLVANT
Proper Name SILTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125496 0 1 4232014 100 MG ( 100 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125496 0 2 4232014 400 MG ( 400 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 28 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
Trade Name TREMFYA
Proper Name GUSELKUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761061 0 1 7132017 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No JAZZ PHARMACEUTICALS INC 1901
Trade Name ERWINAZE
Proper Name ASPARAGINASE ERWINIA CHRYSANTHEMI
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
105359 0 1 11182011 10000 IU ( 10000 IUVIAL )
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103770 0 1 6191998
SOLUTION INTRAMUSCULAR
50 MG05 ML ( 100 MGML )
SINGLE-DOSE VIAL
103770 0 2 6191998
SOLUTION INTRAMUSCULAR
100 MGML ( 100 MGML )
SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name ILUMYA
Proper Name TILDRAKIZUMAB-ASMN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761067 0 1 3202018 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name INTRON A
March 2018 Page 29 of 42
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103132 0 1 641986 10 MIU ( 10 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL INTRAVENOUS SINGLE-DOSE VIAL
103132 0 2 641986 18 MIU ( 18 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL
103132 0 3 641986 50 MIU ( 50 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL
103132 0 4 641986 228 MIU38 ML ( 6 MIUML )
SOLUTION INTRAMUSCULAR SUBCUTANEOUS MULTI-DOSE VIAL
103132 0 5 641986 32 MIU32 ML ( 10 MIUML )
SOLUTION INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL MULTI-DOSE VIAL
Trade Name KEYTRUDA
Proper Name PEMBROLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125514 0 1 942014 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125514 1 2 1152015 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 0 1 1192001 74 MCG ( 74 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SYLATRON
Proper Name PEGINTERFERON ALFA-2B
March 2018 Page 30 of 42
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 5153 2 3292011 296 MCG ( 296 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 3 3292011 444 MCG ( 444 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 4 3292011 888 MCG ( 888 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name ZINPLAVA
Proper Name BEZLOTOXUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761046 0 1 10212016 1000 MG40 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No MERZ PHARMACEUTICALS GMBH 1830
Trade Name XEOMIN
Proper Name INCOBOTULINUMTOXINA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125360 0 1 7302010
POWDER INTRAMUSCULAR
50 U ( 50 UVIAL )
SINGLE-DOSE VIAL
125360 0 2 7302010
POWDER INTRAMUSCULAR
100 U ( 100 UVIAL )
SINGLE-DOSE VIAL
125360 3 3 11202015
POWDER INTRAMUSCULAR
200 U ( 200 UVIAL )
SINGLE-DOSE VIAL
March 2018 Page 31 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
Trade Name ARZERRA
Proper Name OFATUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125326 0 1 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG5 ML ( 20 MGML )
125326 0 2 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1000 MG50 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
125504 0
COSENTYX
SECUKINUMAB
Approval Date Product
1212015 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
150 MG ( 150 MGVIAL )
125504 0 2 1212015
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MGML ( 150 MGML )
125504 0 3 1212015
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MGML ( 150 MGML )
Trade Name
Proper Name
BLASTN
125290 0
EXTAVIA
INTERFERON BETA-1B
Approval Date Product
8142009 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
03 MG ( 03 MGVIAL )
Trade Name
Proper Name
BLASTN
125319 0
ILARIS
CANAKINUMAB
Approval Date Product
6172009 1
PotencyDosage FormRoutePresentation
180 MGVIAL ( 180 MGVIAL )
March 2018 Page 32 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
125319 88 2 12222016 150 MG ( 150 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
125319 0 3 12222016 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SIMULECT
Proper Name BASILIXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103764 0 1 5121998 10 MG ( 10 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
103764 0 2 5121998 20 MG ( 20 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No NPS PHARMACEUTICALS INC 1908
Trade Name NATPARA
Proper Name PARATHYROID HORMONE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 33 of 42
CDER Billable Biologic Product List
ApplicantLicense No PROMETHEUS LABORATORIES INC 1848
Trade Name PROLEUKIN
Proper Name ALDESLEUKIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103293 0 1 551992 22 MIU ( 22 MIUVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760
Trade Name ARCALYST
Proper Name RILONACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125249 0 1 2272008
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
220MG ( 220MGVIAL )
Trade Name
Proper Name
DUPIXENT
DUPILUMAB
BLASTN
761055 0
Product
1
Approval Date
3282017
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
300 MG2 ML ( 150 MGML )
Trade Name
Proper Name
EYLEA
AFLIBERCEPT
BLASTN
125387 0
Product
1
Approval Date
11182011
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
2 MG005 ML ( 40 MGML )
March 2018 Page 34 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Trade Name ELITEK
Proper Name RASBURICASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103946 0 1 7122002
POWDER INTRAVENOUS SINGLE-DOSE VIAL
15 MG ( 15 MGVIAL )
103946 5020 2 162006
POWDER INTRAVENOUS SINGLE-DOSE VIAL
75 MG ( 75 MGVIAL )
Trade Name
Proper Name
BLASTN
761037 0
KEVZARA
SARILUMAB
Approval Date Product
5222017 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MG114 ML ( 13158 MGML )
761037 0 2 5222017
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MG114 ML ( 17544 MGML )
761037 1 3 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MG114 ML ( 13158 MGML )
761037 1 4 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
200 MG114 ML ( 17544 MGML )
Trade Name
Proper Name
BLASTN
103362 0
LEUKINE
SARGRAMOSTIM
Approval Date Product
351991 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
250 MCG ( 250 MCGVIAL )
103362 0 2 351991
SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL
500 MCGML ( 500 MCGML )
Trade Name PRALUENT
March 2018 Page 35 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Proper Name ALIROCUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125559 0 1 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 2 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 3 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125559 0 4 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name ZALTRAP
Proper Name ZIV-AFLIBERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125418 0 1 832012 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125418 0 2 832012 200 MG8 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SEATTLE GENETICS INC 1853
Trade Name ADCETRIS
Proper Name BRENTUXIMAB VEDOTIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125388 1 1 8192011 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 36 of 42
CDER Billable Biologic Product List
ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593
Trade Name ELAPRASE
Proper Name IDURSULFASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125151 0 1 7242006 6 MG3 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SICOR BIOTECH UAB 1803
Trade Name GRANIX
Proper Name TBO-FILGRASTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125294 0 1 8292012
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
300 MCG0 5 ML ( 600 MCGML )
125294 0 2 8292012
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
480 MCG08 ML ( 600 MCGML )
ApplicantLicense No SMITH AND NEPHEW INC 2004
Trade Name REGRANEX
Proper Name BECAPLERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103691 0 1 12161997
GEL TOPICAL
100 UG ( 100 UGGM )
Trade Name
Proper Name
SANTYL
COLLAGENASE
BLASTN
101995 0
Product
1
Approval Date
641965
PotencyDosage FormRoutePresentation
OINTMENT TOPICAL
30 G amp 90 G TUBE ( 250 UGRAM )
March 2018 Page 37 of 42
CDER Billable Biologic Product List
ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718
Trade Name MYOBLOC
Proper Name RIMABOTULINUM TOXIN B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103846 0 1 1282002
SOLUTION INTRAMUSCULAR
2500 IU05 ML ( 5000 IUML )
SINGLE-DOSE VIAL
103846 0 3 1282002
SOLUTION INTRAMUSCULAR
10000 IU2 ML ( 5000 IUML )
SINGLE-DOSE VIAL
Proper Name RIMABOTULINUMTOXINB
BLASTN
103846 0
Product
2
Approval Date
1282002
PotencyDosage FormRoutePresentation
SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL
5000 IUML ( 5000 IUML )
ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832
Trade Name ZEVALIN
Proper Name IBRITUMOMAB TIUXETAN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125019 0 1 2192002 32 MG2 ML ( 16 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
Trade Name KEPIVANCE
Proper Name PALIFERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125103 0 1 12152004 625 MG ( 625 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name KINERET
Proper Name ANAKINRA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 38 of 42
CDER Billable Biologic Product List
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898
Trade Name ENTYVIO
Proper Name VEDOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125476 0 1 5202014 300 MG ( 300 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No TEVA RESPIRATORY LLC 2047
Trade Name CINQAIR
Proper Name RESLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761033 0 1 3232016 100 MG10 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No THERATECHNOLOGIES INC 2091
Trade Name TROGARZO
Proper Name IBALIZUMAB-UIYK
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761065 0 1 362018 200 MG133 ML ( 150 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 39 of 42
CDER Billable Biologic Product List
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
0375 MG03 ML ( 125 MGML )2222017 125422 038 1
ApplicantLicense No UCB INC 1736
Trade Name CIMZIA
Proper Name CERTOLIZUMAB PEGOL
BLASTN Approval Date PotencyDosage FormRoutePresentation Product
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
200 MG ( 200 MGVIAL ) 4222008 125160 0 1
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )5132009 125160 080 2
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
Trade Name CRYSVITA
Proper Name BUROSUMAB-TWZA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761068 0 1 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
10 MGML ( 10 MGML )
761068 0 2 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
20 MGML ( 20 MGML )
761068 0
Trade Name
Proper Name
BLASTN
March 2018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML ) 4172018 3
MEPSEVII
VESTRONIDASE ALFA-VJBK
Approval Date PotencyDosage FormRoutePresentation Product
Page 40 of 42
CDER Billable Biologic Product List
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
761047 0 1 11152017 10 MG5 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No UNITED THERAPEUTICS CORP 1993
Trade Name UNITUXIN
Proper Name DINUTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125516 0 1 3102015 175 MG5 ML ( 35 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053
Trade Name SILIQ
Proper Name BRODALUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761032 0 1 2152017 210 MG15 ML ( 140 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 41 of 42
CDER Billable Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No WYETH PHARMACEUTICALS INC 0003
Trade Name BESPONSA
Proper Name INOTUZUMAB OZOGAMICIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761040 0 1 8172017 09 MG ( 09 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 42 of 42
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 1 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
9172001 103951 0 26
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
200 MCGML ( 200 MCGML ) 09272012
103951 0 27 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
200 MCG04 ML ( 500 MCGML ) 09272012
103951 0 28 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
300 MCGML ( 300 MCGML ) 09272012
103951 0 29 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
300 MCG06 ML ( 500 MCGML ) 09272012
103951 0 30 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
500 MCGML ( 500 MCGML ) 09272012
ApplicantLicense No ASTELLAS PHARMACEUTICALS US INC 1748
Trade Name AMEVIVE
Proper Name ALEFACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125036 0 1 1302003 75 MGVIAL ( 75 MGVIAL ) 09242008
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
125036 0 2 1302003 15 MGVIAL ( 15 MGVIAL ) 09282012
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No BOEHRINGER INGELHEIM PHARMA KG 1251
Trade Name VERLUMA
Proper Name NOFETUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103769 0 1 10131998 10 MGML ( 10 MGML ) 08132013
INTRAVENOUS
March 2018 Page 2 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No CENTOCOR ORTHO BIOTECH PRODUCTS LP 1824
Trade Name ORTHOCLONE OKT3
Proper Name MUROMONAB-CD3
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103463 0 1 9141992 1 MGML ( 1 MGML ) 01112012
SOLUTION INTRAVENOUS AMPULE
ApplicantLicense No EISAI INCORPORATED 1862
Trade Name ONTAK
Proper Name DENILEUKIN DIFTITOX
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103767 0 1 251999 300 MCG2 ML ( 150 MCGML ) 01302014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No ELI LILLY AND CO 1611
Trade Name XIGRIS
Proper Name DROTRECOGIN ALFA (ACTIVATED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125029 0 1 11212001 5 MGVIAL ( 5 MGVIAL ) 10262011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125029 0 2 11212001 20 MGVIAL ( 20 MGVIAL ) 10102011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GENENTECH INC 1048
Trade Name RAPTIVA
Proper Name EFALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125075 0 1 10272003 125 MGVIAL ( 125 MGVIAL ) 09012009
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
March 2018 Page 3 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103976 0 2 6202003 125 MGVIAL ( 125 MGVIAL ) 08252016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103948 0 3 572001 10 MGVIAL ( 10 MGVIAL ) 07062011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name MYOZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125141 0 1 4282006 50 MGVIAL ( 50 MGVIAL ) 10172014
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name BEXXAR THERAPEUTIC REGIME
Proper Name TOSITUMOMAB AND IODINE I-131 TOSITUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125011 0 1 6272003 01 MGML I-131 TOSITUMOMAB ( 01 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 2 6272003 11 MGML I-131 TOSITUMOMAB ( 11 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 3 6272003 14 MGML TOSITUMOMAB ( 14 MGML 03102014 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 4 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No HEMISPHERX BIOPHARMA INC 1703
Trade Name ALFERON N INJECTION
Proper Name INTERFERON ALFA-N3 (HUMAN LEUKOCYTE DERIVED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103158 0 1 10101989 5 MIUVIAL ( 5 MIUVIAL ) 06272013
SOLUTION INTRALESIONAL MULTI-DOSE VIAL
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name ROFERON A
Proper Name INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103145 0 1 641986 3 MIU05 ML ( 3 MIU05 ML ) 06012009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name ZENAPAX
Proper Name DACLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103749 0 1 12101997 25 MG5 ML ( 25 MG5 ML ) 07072011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No KADMON PHARMACEUTICALS LLC 1867
Trade Name INFERGEN
Proper Name INTERFERON ALFACON-1
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103663 0 1 1061997 9 MCG03 ML ( 30 MCGML ) 07252013
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 5 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103770 0 3 6191998 50 MGVIAL ( 50 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
103770 0 4 6191998 100 MGVIAL ( 100 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name INTRON A
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103132 0 6 641986 10 MIUML ( 10 MIUML ) 09232013
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103132 0 7 641986 225 MIU15 ML ( 225 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 8 641986 375 MIU15 ML ( 375 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 9 641986 75 MIU15 ML ( 75 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103949 0 5 1192001 675 MCGPEN ( 675 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 6 1192001 108 MCGPEN ( 108 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
March 2018 Page 6 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name PEGINTRON
103949 0 7 1192001 1184 MCGVIAL ( 1184 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 8 1192001 162 MCGPEN ( 162 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 9 1192001 1776 MCGVIAL ( 1776 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 10 1192001 2025 MCGPEN ( 2025 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 11 1192001 222 MCGVIAL ( 222 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No PALATIN TECHNOLOGIES INC 1588
Trade Name NEUTROSPEC TECHNETIUM (99M TC)
Proper Name FANOLESOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103928 0 1 722004 025 MGVIAL ( 025 MGVIAL ) 09222008
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No RECORDATI RARE DISEASES INC 1899
Trade Name ELSPAR
Proper Name ASPARAGINASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
101063 0 1 1101978 10000 IU ( 10000 IUVIAL ) 04092014
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
March 2018 Page 7 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No SCHERING CORP 0994
Trade Name PEGINTRONREBETOL COMBO PACK
Proper Name PEGINTERFERON ALFA-2B AND RIBAVIRIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125196 0 1 6132008 ( 4 (120 MCG05ML) REDIPEN amp 140 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 2 6132008 ( 4 (150 MCG05ML) REDIPEN amp 168 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 3 6132008 ( 4 (150 MCG05ML) REDIPEN amp 196 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 4 6132008 ( 4 (50 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 5 6132008 ( 4 (80 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125422 0 2 10172012 05 MG ( 25 MGML ) 08082017
SOLUTION INTRAVETREAL SINGLE-DOSE VIAL
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125164 0 10 11142007 50 MCGML ( 50 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 8 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
125164 0 11 11142007 100 MCGML ( 100 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 12 11142007 200 MCGML ( 200 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 13 11142007 300 MCGML ( 300 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 14 11142007 400 MCGML ( 400 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 15 11142007 400 MCG06 ML ( 400 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 16 11142007 600 MCGML ( 600 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 17 11142007 600 MCG06 ML ( 600 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 18 11142007 800 MCG06 ML ( 800 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 19 11142007 1000 MCGML ( 1000 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 9 of 9
CDER Billable Biologic Product List
ApplicantLicense No AMGEN INC 1080
Proper Name FILGRASTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103353 0 1 2201991 300 MCGML ( 300 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103353 0 2 2201991 300 MCG05 ML ( 600 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103353 0 3 2201991 480 MCG16 ML ( 300 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103353 0 4 2201991 480 MCG08 ML ( 600 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
Trade Name NPLATE
Proper Name ROMIPLOSTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125268 0 1 8222008 250 MCG ( 250 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
125268 0 2 8222008 500 MCG ( 500 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name PROCRIT
Proper Name EPOETIN ALFA - PRESERVATIVE FREE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103234 0 5 611989 40000 UML ( 40000 UML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name PROLIA
Proper Name DENOSUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 7 of 42
CDER Billable Biologic Product List
ApplicantLicense No AMGEN INC 1080
125320 0 1 612010 60 MGML ( 60 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name REPATHA
Proper Name EVOLOCUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125522 0 1 8272015 140 MGML ( 140 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125522 1 2 7112016 420 MG35 ML ( 120 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125522 0 3 8272015 140 MGML ( 140 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name VECTIBIX
Proper Name PANITUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125147 0 1 9272006 100 MG5 ML ( 20 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125147 0 2 9272006 200 MG10 ML ( 20 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125147 0 3 9272006 400 MG20 ML ( 20 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name XGEVA
Proper Name DENOSUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125320 7 2 11182010 120 MG17 ML ( 70 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 8 of 42
CDER Billable Biologic Product List
ApplicantLicense No ASTRAZENECA UK LTD 2043
Trade Name FASENRA
Proper Name BENRALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761070 0 1 11142017
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
30 MGML ( 30 MGML )
Trade Name
Proper Name
IMFINZI
DURVALUMAB
BLASTN
761069 0
Product
1
Approval Date
512017
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
120 MG24 ML ( 50 MGML )
761069 0 2 512017
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
500 MG10 ML ( 50 MGML )
ApplicantLicense No AUXILIUM PHARMACEUTICALS INC 1816
Trade Name XIAFLEX
Proper Name CLOSTRIDIAL COLLAGENASE HISTOLYTICUM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125338 0 1 222010 09 MG ( 09 MGVIAL )
POWDER INTRALESIONAL SINGLE-DOSE VIAL
ApplicantLicense No AYTU BIOSCIENCES INC 2035
Trade Name PROSTASCINT
Proper Name CAPROMAB PENDETIDE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103608 0 1 10281996 05 MGML ( 05 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 9 of 42
CDER Billable Biologic Product List
ApplicantLicense No BAXALTA US INC 2020
Trade Name ONCASPAR
Proper Name PEGASPARGASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103411 0 1 211994 3750 IU5 ML ( 750 IUML )
SOLUTION INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No BAYER HEALTHCARE PHARMACEUTICALS INC 1778
Trade Name BETASERON
Proper Name INTERFERON BETA-1B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103471 0 1 7231993 03 MG ( 03 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No BIOGEN INC 1697
Trade Name AVONEX
Proper Name INTERFERON BETA 1A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103628 0 1 5171996
POWDER INTRAMUSCULAR
30 MCG ( 30 MCGVIAL )
SINGLE-DOSE VIAL
103628 0 2 5171996
SOLUTION INTRAMUSCULAR PREFILLED SYRINGE
30 MCG05 ML ( 30 MCG05 ML )
103628 0 3 5171996
SOLUTION INTRAMUSCULAR AUTOINJECTOR
30 MCG05 ML ( 30 MCG05 ML )
Trade Name
Proper Name
BLASTN
125499 0
PLEGRIDY
PEGINTERFERON BETA-1A
Approval Date PotencyDosage FormRoutePresentation Product
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
63 MCG05 ML ( 126 MCGML ) 8152014 1
March 2018 Page 10 of 42
CDER Billable Biologic Product List
ApplicantLicense No BIOGEN INC 1697
125499 0 2 8152014 125 MCG05 ML ( 250 MCGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125499 0 3 8152014 63 MCG05 ML ( 126 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125499 0 4 8152014 94 MCG05 ML ( 188 MCGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125499 0 5 8152014 94 MCG05 ML ( 188 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125499 0 6 8152014 125 MCG05 ML ( 250 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name TYSABRI
Proper Name NATALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125104 0 1 11232004 300 MG15 ML ( 20 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name ZINBRYTA
Proper Name DACLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761029 0 1 5272016 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
761029 0 2 5272016 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 11 of 42
CDER Billable Biologic Product List
ApplicantLicense No BIOMARIN PHARMACEUTICAL INC 1649
Trade Name ALDURAZYME
Proper Name LARONIDASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125058 0 1 4302003
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
29 MG5 ML ( 058 MGML )
Trade Name
Proper Name
BRINEURA
CERLIPONASE ALFA
BLASTN
761052 0
Product
1
Approval Date
4272017
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENTRICULAR SINGLE-DOSE VIAL
150 MG5 ML ( 30 MGML )
Trade Name
Proper Name
NAGLAZYME
GALSULFASE
BLASTN
125117 0
Product
1
Approval Date
5312005
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
5 MG 5ML ( 1 MGML )
Trade Name
Proper Name
VIMIZIM
ELOSULFASE ALFA
BLASTN
125460 0
Product
1
Approval Date
2142014
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
5 MG5 ML ( 1 MGML )
ApplicantLicense No BOEHRINGER INGELHEIM PHARMACEUTICALS INC 2006
Trade Name PRAXBIND
Proper Name IDARUCIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761025 0 1 10162015 2500 MG50 ML ( 50 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 12 of 42
CDER Billable Biologic Product List
ApplicantLicense No BRISTOL MYERS SQUIBB CO 1713
Trade Name EMPLICITI
Proper Name ELOTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761035 0 1 11302015
POWDER INTRAVENOUS SINGLE-DOSE VIAL
300 MG ( 300 MGVIAL )
761035 0 2 11302015
POWDER INTRAVENOUS SINGLE-DOSE VIAL
400 MG ( 400 MGVIAL )
Trade Name
Proper Name
BLASTN
125288 0
NULOJIX
BELATACEPT
Approval Date Product
6152011 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
250 MG ( 250 MGVIAL )
Trade Name
Proper Name
BLASTN
125554 0
OPDIVO
NIVOLUMAB
Approval Date Product
12222014 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
40 MG4 ML ( 10 MGML )
125554 0 2 12222014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG10 ML ( 10 MGML )
125554 0 3 12222014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
240 MG24 ML ( 10 MGML )
Trade Name
Proper Name
BLASTN
125118 0
ORENCIA
ABATACEPT
Approval Date Product
12232005 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
250 MG ( 250 MGVIAL )
March 2018 Page 13 of 42
CDER Billable Biologic Product List
ApplicantLicense No BRISTOL MYERS SQUIBB CO 1713
125118 122 2 7292011 50 MG04 ML ( 125 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125118 122 3 7292011 875 MG07 ML ( 125 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125118 122 4 7292011 125 MGML ( 125 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125118 122 5 7292011 125 MGML ( 125 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name YERVOY
Proper Name IPILIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125377 0 1 3252011 50 MG10 ML ( 5 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125377 0 2 3252011 200 MG40 ML ( 5 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No BTG INTERNATIONAL INC 1861
Trade Name VORAXAZE
Proper Name GLUCARPIDASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125327 0 1 1172012 1000 U ( 1000 UVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 14 of 42
CDER Billable Biologic Product List
ApplicantLicense No DYAX CORPORATION 1789
Trade Name KALBITOR
Proper Name ECALLANTIDE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125277 0 1 1212009 10 MGML ( 10 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No EKR THERAPEUTICS INC 1814
Trade Name RETAVASE
Proper Name RETEPLASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103786 0 1 561998 10 U ( 10 UVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No ELI LILLY AND CO 1891
Trade Name CYRAMZA
Proper Name RAMUCIRUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125477 0 1 4212014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG10 ML ( 10 MGML )
125477 0 2 4212014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
500 MG50 ML ( 10 MGML )
Trade Name
Proper Name
BLASTN
761038 0
LARTRUVO
OLARATUMAB
Approval Date Product
10192016 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
500 MG50 ML ( 10 MGML )
761038 0 2 10192016
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
190 MG19 ML ( 10 MGML )
March 2018 Page 15 of 42
CDER Billable Biologic Product List
ApplicantLicense No ELI LILLY AND CO 1891
Trade Name PORTRAZZA
Proper Name NECITUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125547 0 1 11242015
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
800 MG50 ML ( 16 MGML )
Trade Name
Proper Name
TALTZ
IXEKIZUMAB
BLASTN
125521 0
Product
1
Approval Date
3222016
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
80 MGML ( 80 MGML )
125521 0 2 3222016
SOLUTION SUBCUTANEOUS AUTOINJECTOR
80 MGML ( 80 MGML )
Trade Name
Proper Name
TRULICITY
DULAGLUTIDE
BLASTN
125469 0
Product
1
Approval Date
9182014
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
075 MG05 ML ( 075 MG05 ML )
125469 0 2 9182014
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
15 MG05 ML ( 15 MG05 ML )
125469 0 3 9182014
SOLUTION SUBCUTANEOUS AUTOINJECTOR
075 MG05 ML ( 075 MG05 ML )
125469 0 4 9182014
SOLUTION SUBCUTANEOUS AUTOINJECTOR
15 MG05 ML ( 15 MG05 ML )
March 2018 Page 16 of 42
CDER Billable Biologic Product List
ApplicantLicense No ELUSYS THERAPEUTICS INC 1907
Trade Name ANTHIM
Proper Name OBILTOXAXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125509 1 1 3182016 600 MG6 ML ( 100 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No EMD SERONO INC 1773
Trade Name BAVENCIO
Proper Name AVELUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761049 0 1 3232017
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
200 MG10 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
103780 0
REBIF
INTERFERON BETA 1A
Approval Date Product
372002 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
88 MCG02 ML ( 44 MCGML )
103780 0 2 372002
SOLUTION SUBCUTANEOUS AUTOINJECTOR
88 MCG02 ML ( 44 MCGML )
103780 0 3 372002
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
22 MCG05 ML ( 44 MCGML )
103780 0 4 372002
SOLUTION SUBCUTANEOUS AUTOINJECTOR
22 MCG05 ML ( 44 MCGML )
103780 0 5 372002
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
44 MCG05 ML ( 88 MCGML )
103780 0 6 372002
SOLUTION SUBCUTANEOUS AUTOINJECTOR
44 MCG05 ML ( 88 MCGML )
March 2018 Page 17 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name ACTEMRA
Proper Name TOCILIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125276 0 1 182010
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
80 MG4 ML ( 20 MGML )
125276 0 2 182010
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
200 MG10 ML ( 20 MGML )
125276 0 3 182010
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
400 MG20 ML ( 20 MGML )
BLASTN
125472 1
Product
1
Approval Date
10212013
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
162 MG09 ML ( 179 MGML )
Trade Name
Proper Name
BLASTN
103172 0
ACTIVASE
ALTEPLASE
Approval Date Product
11131987 2
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
50 MG ( 50 MGVIAL )
103172 0 3 11131987
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
BLASTN
125085 0
AVASTIN
BEVACIZUMAB
Approval Date Product
2262004 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG4 ML ( 25 MGML )
125085 0 2 2262004
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
400 MG16 ML ( 25 MGML )
March 2018 Page 18 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name CATHFLO ACTIVASE
Proper Name ALTEPLASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103172 0 1 11131987
POWDER INTRACATHETER SINGLE-DOSE VIAL
2 MG ( 2 MGVIAL )
Trade Name
Proper Name
BLASTN
125486 0
GAZYVA
OBINUYUZUMAB
Approval Date Product
1112013 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1000 MG40 ML ( 25 MGML )
Trade Name
Proper Name
BLASTN
761083 0
HEMLIBRA
EMICIZUMAB-KXWH
Approval Date Product
11162017 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML )
761083 0 2 11162017
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
60 MG04 ML ( 150 MGML )
761083 0 3 11162017
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
105 MG07 ML ( 150 MGML )
761083 0 4 11162017
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
150 MGML ( 150 MGML )
Trade Name
Proper Name
BLASTN
103792 0
HERCEPTIN
TRASTUZUMAB
Approval Date Product
9251998 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS MULTI-DOSE VIAL
420 MG ( 420 MGVIAL )
March 2018 Page 19 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
103792 5336 2 2102017 150 MG ( 150 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name KADCYLA
Proper Name ADO-TRASIUZUMAB EMTANSINE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125427 0 1 2222013
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
125427 0 2 2222013
POWDER INTRAVENOUS SINGLE-DOSE VIAL
160 MG ( 160 MGVIAL )
Trade Name
Proper Name
LUCENTIS
RANIBIZUMAB
BLASTN
125156 0
Product
1
Approval Date
6302006
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE
05 MG005 ML ( 10 MGML )
Proper Name RANIDIZUMAB
BLASTN
125156 076
Product
2
Approval Date
8102012
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE
03 MG005 ML ( 6 MGML )
Trade Name
Proper Name
OCREVUS
OCRELIZUMAB
BLASTN
761053 0
Product
1
Approval Date
3282017
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
300 MG10 ML ( 30 MGML )
Trade Name
Proper Name
PERJETA
PERTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 20 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
125409 0 1 682012 420 MG14 ML ( 30 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name PULMOZYME
Proper Name DORNASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103532 0 1 12301993 25 MG25 ML ( 1 MGML )
SOLUTION INHALATION AMPULE
Trade Name RITUXAN
Proper Name RITUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103705 0 1 11261997 100 MG10 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
103705 0 2 11261997 500 MG50 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name RITUXAN HYCELA
Proper Name RITUXIMAB AND HYALURONIDASE HUMAN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761064 0 1 6222017 1400 MG AND 23400 U117 ML ( 11966 MG AND 2000 UML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
761064 0 2 6222017 1600 MG AND 26800 U134 ML ( 11966 MG AND 2000 UML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name TECENTRIQ
Proper Name ATEZOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761034 0 1 582016 1200 MG20 ML ( 60 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name TNKASE
March 2018 Page 21 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Proper Name TENECTEPLASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103909 0 1 622000 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103976 0 1 6202003 150 MG ( 150 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103948 0 1 572001
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML )
Trade Name
Proper Name
FABRAZYME
AGALSIDASE BETA
BLASTN
103979 0
Product
1
Approval Date
4242003
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
5 MG ( 5 MGVIAL )
103979 0 2 4242003
POWDER INTRAVENOUS SINGLE-DOSE VIAL
35 MG ( 35 MGVIAL )
Trade Name
Proper Name
LEMTRADA
ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 22 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENZYME CORP 1596
103948 5139 2 11142014 12 MG12 ML ( 10MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name LUMIZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125291 0 1 5242010 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name NUCALA
Proper Name MEPOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125526 0 1 11142015
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
TANZEUM
ALBIGLUTIDE
BLASTN
125431 0
Product
1
Approval Date
4152014
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS AUTOINJECTOR
30 MG ( 30 MGAUTOINJECTOR )
125431 0 2 4152014
POWDER SUBCUTANEOUS AUTOINJECTOR
50 MG ( 50 MGAUTOINJECTOR )
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name PEGASYS
Proper Name PEGINTERFERON ALFA 2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103964 5204 4 9292011 180 MCG05 ML ( 360 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 23 of 42
CDER Billable Biologic Product List
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Proper Name PEG-INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103964 0 1 10162002 180 MCGML ( 180 MCGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
103964 0 2 10162002 180 MCG05 ML ( 360 MCGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
103964 5204 3 9292011 135 MCG05 ML ( 270 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
ApplicantLicense No HORIZON PHARMA IRELAND LTD 2022
Trade Name ACTIMMUNE
Proper Name INTERFERON GAMMA-1B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103836 0 1 2251999 100 MCG05 ML ( 200 MCGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No HORIZON PHARMA RHEUMATOLOGY LLC 1998
Trade Name KRYSTEXXA
Proper Name PEGLOTICASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125293 0 1 9142010 8MGML ( 8MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 24 of 42
CDER Billable Biologic Product List
ApplicantLicense No HUMAN GENOME SCIENCES INC 1820
Trade Name BENLYSTA
Proper Name BELIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125370 0 1 392011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
120 MG ( 120 MGVIAL )
125370 0 2 392011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
400 MG ( 400 MGVIAL )
125370 0 3 392011
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )
125370 0 4 392011
SOLUTION SUBCUTANEOUS AUTOINJECTOR
200 MGML ( 200 MGML )
BLASTN
761043 0
Product
1
Approval Date
7202017
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )
Trade Name
Proper Name
RAXIBACUMAB
RAXIBACUMAB
BLASTN
125349 0
Product
1
Approval Date
12142012
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1700 MG34 ML ( 50 MGML )
ApplicantLicense No IMCLONE LLC 1695
Trade Name ERBITUX
Proper Name CETUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125084 0 1 2122004 100 MG50 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 25 of 42
CDER Billable Biologic Product List
ApplicantLicense No IMCLONE LLC 1695
125084 0 2 2122004 200 MG100 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No IMMUNEX CORP 1132
Trade Name ENBREL
Proper Name ETANERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103795 0 1 1121998
POWDER SUBCUTANEOUS MULTI-DOSE VIAL
25 MG ( 25 MGVIAL )
103795 5184 2 9272004
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
50 MGML ( 50 MGML )
103795 0 3 9272004
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MGML ( 50 MGML )
103795 5184 4 9272004
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
25 MG05 ML ( 50 MGML )
103795 5556 5 9142017
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MGML ( 50 MGML )
ApplicantLicense No IPSEN BIOPHARM LIMITED 1787
Trade Name DYSPORT
Proper Name ABOBOTULINUMTOXINA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125274 0 1 4292009
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
300 UNITS ( 300 UNITSVIAL )
125274 0 2 4292009
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
500 UNITS ( 500 UNITSVIAL )
March 2018 Page 26 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
Trade Name DARZALEX
Proper Name DARATUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761036 0 1 11162015
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG5 ML ( 20 MGML )
761036 0 2 11162015
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
400 MG20 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
103772 0
REMICADE
INFLIXIMAB
Approval Date Product
8241998 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
BLASTN
103575 0
REOPRO
ABCIXIMAB
Approval Date Product
12221994 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
10 MG5 ML ( 2 MGML )
Trade Name
Proper Name
BLASTN
125289 0
SIMPONI
GOLIMUMAB
Approval Date Product
4242009 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
50 MG05 ML ( 100 MGML )
125289 0 2 4242009
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MG05 ML ( 100 MGML )
125289 0 3 4242009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
100 MGML ( 100 MGML )
March 2018 Page 27 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
125289 0 4 4242009 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name SIMPONI ARIA
Proper Name GOLIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125433 0 1 7182013 50 MG4 ML ( 125 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name STELARA
Proper Name USTEKINUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125261 0 1 9252009 90 MGML ( 90 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125261 0 2 9252009 45 MG05 ML ( 90 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL amp PREFILLED SYRINGE
125261 0 3 9252009 130 MG26 ML ( 5 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761044 0 1 9232016 130 MG26 ML ( 5 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SYLVANT
Proper Name SILTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125496 0 1 4232014 100 MG ( 100 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125496 0 2 4232014 400 MG ( 400 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 28 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
Trade Name TREMFYA
Proper Name GUSELKUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761061 0 1 7132017 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No JAZZ PHARMACEUTICALS INC 1901
Trade Name ERWINAZE
Proper Name ASPARAGINASE ERWINIA CHRYSANTHEMI
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
105359 0 1 11182011 10000 IU ( 10000 IUVIAL )
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103770 0 1 6191998
SOLUTION INTRAMUSCULAR
50 MG05 ML ( 100 MGML )
SINGLE-DOSE VIAL
103770 0 2 6191998
SOLUTION INTRAMUSCULAR
100 MGML ( 100 MGML )
SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name ILUMYA
Proper Name TILDRAKIZUMAB-ASMN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761067 0 1 3202018 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name INTRON A
March 2018 Page 29 of 42
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103132 0 1 641986 10 MIU ( 10 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL INTRAVENOUS SINGLE-DOSE VIAL
103132 0 2 641986 18 MIU ( 18 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL
103132 0 3 641986 50 MIU ( 50 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL
103132 0 4 641986 228 MIU38 ML ( 6 MIUML )
SOLUTION INTRAMUSCULAR SUBCUTANEOUS MULTI-DOSE VIAL
103132 0 5 641986 32 MIU32 ML ( 10 MIUML )
SOLUTION INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL MULTI-DOSE VIAL
Trade Name KEYTRUDA
Proper Name PEMBROLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125514 0 1 942014 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125514 1 2 1152015 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 0 1 1192001 74 MCG ( 74 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SYLATRON
Proper Name PEGINTERFERON ALFA-2B
March 2018 Page 30 of 42
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 5153 2 3292011 296 MCG ( 296 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 3 3292011 444 MCG ( 444 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 4 3292011 888 MCG ( 888 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name ZINPLAVA
Proper Name BEZLOTOXUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761046 0 1 10212016 1000 MG40 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No MERZ PHARMACEUTICALS GMBH 1830
Trade Name XEOMIN
Proper Name INCOBOTULINUMTOXINA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125360 0 1 7302010
POWDER INTRAMUSCULAR
50 U ( 50 UVIAL )
SINGLE-DOSE VIAL
125360 0 2 7302010
POWDER INTRAMUSCULAR
100 U ( 100 UVIAL )
SINGLE-DOSE VIAL
125360 3 3 11202015
POWDER INTRAMUSCULAR
200 U ( 200 UVIAL )
SINGLE-DOSE VIAL
March 2018 Page 31 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
Trade Name ARZERRA
Proper Name OFATUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125326 0 1 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG5 ML ( 20 MGML )
125326 0 2 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1000 MG50 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
125504 0
COSENTYX
SECUKINUMAB
Approval Date Product
1212015 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
150 MG ( 150 MGVIAL )
125504 0 2 1212015
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MGML ( 150 MGML )
125504 0 3 1212015
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MGML ( 150 MGML )
Trade Name
Proper Name
BLASTN
125290 0
EXTAVIA
INTERFERON BETA-1B
Approval Date Product
8142009 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
03 MG ( 03 MGVIAL )
Trade Name
Proper Name
BLASTN
125319 0
ILARIS
CANAKINUMAB
Approval Date Product
6172009 1
PotencyDosage FormRoutePresentation
180 MGVIAL ( 180 MGVIAL )
March 2018 Page 32 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
125319 88 2 12222016 150 MG ( 150 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
125319 0 3 12222016 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SIMULECT
Proper Name BASILIXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103764 0 1 5121998 10 MG ( 10 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
103764 0 2 5121998 20 MG ( 20 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No NPS PHARMACEUTICALS INC 1908
Trade Name NATPARA
Proper Name PARATHYROID HORMONE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 33 of 42
CDER Billable Biologic Product List
ApplicantLicense No PROMETHEUS LABORATORIES INC 1848
Trade Name PROLEUKIN
Proper Name ALDESLEUKIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103293 0 1 551992 22 MIU ( 22 MIUVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760
Trade Name ARCALYST
Proper Name RILONACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125249 0 1 2272008
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
220MG ( 220MGVIAL )
Trade Name
Proper Name
DUPIXENT
DUPILUMAB
BLASTN
761055 0
Product
1
Approval Date
3282017
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
300 MG2 ML ( 150 MGML )
Trade Name
Proper Name
EYLEA
AFLIBERCEPT
BLASTN
125387 0
Product
1
Approval Date
11182011
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
2 MG005 ML ( 40 MGML )
March 2018 Page 34 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Trade Name ELITEK
Proper Name RASBURICASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103946 0 1 7122002
POWDER INTRAVENOUS SINGLE-DOSE VIAL
15 MG ( 15 MGVIAL )
103946 5020 2 162006
POWDER INTRAVENOUS SINGLE-DOSE VIAL
75 MG ( 75 MGVIAL )
Trade Name
Proper Name
BLASTN
761037 0
KEVZARA
SARILUMAB
Approval Date Product
5222017 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MG114 ML ( 13158 MGML )
761037 0 2 5222017
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MG114 ML ( 17544 MGML )
761037 1 3 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MG114 ML ( 13158 MGML )
761037 1 4 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
200 MG114 ML ( 17544 MGML )
Trade Name
Proper Name
BLASTN
103362 0
LEUKINE
SARGRAMOSTIM
Approval Date Product
351991 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
250 MCG ( 250 MCGVIAL )
103362 0 2 351991
SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL
500 MCGML ( 500 MCGML )
Trade Name PRALUENT
March 2018 Page 35 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Proper Name ALIROCUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125559 0 1 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 2 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 3 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125559 0 4 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name ZALTRAP
Proper Name ZIV-AFLIBERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125418 0 1 832012 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125418 0 2 832012 200 MG8 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SEATTLE GENETICS INC 1853
Trade Name ADCETRIS
Proper Name BRENTUXIMAB VEDOTIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125388 1 1 8192011 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 36 of 42
CDER Billable Biologic Product List
ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593
Trade Name ELAPRASE
Proper Name IDURSULFASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125151 0 1 7242006 6 MG3 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SICOR BIOTECH UAB 1803
Trade Name GRANIX
Proper Name TBO-FILGRASTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125294 0 1 8292012
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
300 MCG0 5 ML ( 600 MCGML )
125294 0 2 8292012
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
480 MCG08 ML ( 600 MCGML )
ApplicantLicense No SMITH AND NEPHEW INC 2004
Trade Name REGRANEX
Proper Name BECAPLERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103691 0 1 12161997
GEL TOPICAL
100 UG ( 100 UGGM )
Trade Name
Proper Name
SANTYL
COLLAGENASE
BLASTN
101995 0
Product
1
Approval Date
641965
PotencyDosage FormRoutePresentation
OINTMENT TOPICAL
30 G amp 90 G TUBE ( 250 UGRAM )
March 2018 Page 37 of 42
CDER Billable Biologic Product List
ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718
Trade Name MYOBLOC
Proper Name RIMABOTULINUM TOXIN B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103846 0 1 1282002
SOLUTION INTRAMUSCULAR
2500 IU05 ML ( 5000 IUML )
SINGLE-DOSE VIAL
103846 0 3 1282002
SOLUTION INTRAMUSCULAR
10000 IU2 ML ( 5000 IUML )
SINGLE-DOSE VIAL
Proper Name RIMABOTULINUMTOXINB
BLASTN
103846 0
Product
2
Approval Date
1282002
PotencyDosage FormRoutePresentation
SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL
5000 IUML ( 5000 IUML )
ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832
Trade Name ZEVALIN
Proper Name IBRITUMOMAB TIUXETAN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125019 0 1 2192002 32 MG2 ML ( 16 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
Trade Name KEPIVANCE
Proper Name PALIFERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125103 0 1 12152004 625 MG ( 625 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name KINERET
Proper Name ANAKINRA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 38 of 42
CDER Billable Biologic Product List
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898
Trade Name ENTYVIO
Proper Name VEDOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125476 0 1 5202014 300 MG ( 300 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No TEVA RESPIRATORY LLC 2047
Trade Name CINQAIR
Proper Name RESLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761033 0 1 3232016 100 MG10 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No THERATECHNOLOGIES INC 2091
Trade Name TROGARZO
Proper Name IBALIZUMAB-UIYK
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761065 0 1 362018 200 MG133 ML ( 150 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 39 of 42
CDER Billable Biologic Product List
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
0375 MG03 ML ( 125 MGML )2222017 125422 038 1
ApplicantLicense No UCB INC 1736
Trade Name CIMZIA
Proper Name CERTOLIZUMAB PEGOL
BLASTN Approval Date PotencyDosage FormRoutePresentation Product
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
200 MG ( 200 MGVIAL ) 4222008 125160 0 1
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )5132009 125160 080 2
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
Trade Name CRYSVITA
Proper Name BUROSUMAB-TWZA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761068 0 1 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
10 MGML ( 10 MGML )
761068 0 2 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
20 MGML ( 20 MGML )
761068 0
Trade Name
Proper Name
BLASTN
March 2018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML ) 4172018 3
MEPSEVII
VESTRONIDASE ALFA-VJBK
Approval Date PotencyDosage FormRoutePresentation Product
Page 40 of 42
CDER Billable Biologic Product List
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
761047 0 1 11152017 10 MG5 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No UNITED THERAPEUTICS CORP 1993
Trade Name UNITUXIN
Proper Name DINUTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125516 0 1 3102015 175 MG5 ML ( 35 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053
Trade Name SILIQ
Proper Name BRODALUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761032 0 1 2152017 210 MG15 ML ( 140 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 41 of 42
CDER Billable Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No WYETH PHARMACEUTICALS INC 0003
Trade Name BESPONSA
Proper Name INOTUZUMAB OZOGAMICIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761040 0 1 8172017 09 MG ( 09 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 42 of 42
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 1 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
9172001 103951 0 26
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
200 MCGML ( 200 MCGML ) 09272012
103951 0 27 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
200 MCG04 ML ( 500 MCGML ) 09272012
103951 0 28 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
300 MCGML ( 300 MCGML ) 09272012
103951 0 29 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
300 MCG06 ML ( 500 MCGML ) 09272012
103951 0 30 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
500 MCGML ( 500 MCGML ) 09272012
ApplicantLicense No ASTELLAS PHARMACEUTICALS US INC 1748
Trade Name AMEVIVE
Proper Name ALEFACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125036 0 1 1302003 75 MGVIAL ( 75 MGVIAL ) 09242008
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
125036 0 2 1302003 15 MGVIAL ( 15 MGVIAL ) 09282012
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No BOEHRINGER INGELHEIM PHARMA KG 1251
Trade Name VERLUMA
Proper Name NOFETUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103769 0 1 10131998 10 MGML ( 10 MGML ) 08132013
INTRAVENOUS
March 2018 Page 2 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No CENTOCOR ORTHO BIOTECH PRODUCTS LP 1824
Trade Name ORTHOCLONE OKT3
Proper Name MUROMONAB-CD3
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103463 0 1 9141992 1 MGML ( 1 MGML ) 01112012
SOLUTION INTRAVENOUS AMPULE
ApplicantLicense No EISAI INCORPORATED 1862
Trade Name ONTAK
Proper Name DENILEUKIN DIFTITOX
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103767 0 1 251999 300 MCG2 ML ( 150 MCGML ) 01302014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No ELI LILLY AND CO 1611
Trade Name XIGRIS
Proper Name DROTRECOGIN ALFA (ACTIVATED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125029 0 1 11212001 5 MGVIAL ( 5 MGVIAL ) 10262011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125029 0 2 11212001 20 MGVIAL ( 20 MGVIAL ) 10102011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GENENTECH INC 1048
Trade Name RAPTIVA
Proper Name EFALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125075 0 1 10272003 125 MGVIAL ( 125 MGVIAL ) 09012009
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
March 2018 Page 3 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103976 0 2 6202003 125 MGVIAL ( 125 MGVIAL ) 08252016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103948 0 3 572001 10 MGVIAL ( 10 MGVIAL ) 07062011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name MYOZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125141 0 1 4282006 50 MGVIAL ( 50 MGVIAL ) 10172014
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name BEXXAR THERAPEUTIC REGIME
Proper Name TOSITUMOMAB AND IODINE I-131 TOSITUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125011 0 1 6272003 01 MGML I-131 TOSITUMOMAB ( 01 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 2 6272003 11 MGML I-131 TOSITUMOMAB ( 11 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 3 6272003 14 MGML TOSITUMOMAB ( 14 MGML 03102014 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 4 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No HEMISPHERX BIOPHARMA INC 1703
Trade Name ALFERON N INJECTION
Proper Name INTERFERON ALFA-N3 (HUMAN LEUKOCYTE DERIVED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103158 0 1 10101989 5 MIUVIAL ( 5 MIUVIAL ) 06272013
SOLUTION INTRALESIONAL MULTI-DOSE VIAL
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name ROFERON A
Proper Name INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103145 0 1 641986 3 MIU05 ML ( 3 MIU05 ML ) 06012009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name ZENAPAX
Proper Name DACLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103749 0 1 12101997 25 MG5 ML ( 25 MG5 ML ) 07072011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No KADMON PHARMACEUTICALS LLC 1867
Trade Name INFERGEN
Proper Name INTERFERON ALFACON-1
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103663 0 1 1061997 9 MCG03 ML ( 30 MCGML ) 07252013
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 5 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103770 0 3 6191998 50 MGVIAL ( 50 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
103770 0 4 6191998 100 MGVIAL ( 100 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name INTRON A
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103132 0 6 641986 10 MIUML ( 10 MIUML ) 09232013
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103132 0 7 641986 225 MIU15 ML ( 225 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 8 641986 375 MIU15 ML ( 375 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 9 641986 75 MIU15 ML ( 75 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103949 0 5 1192001 675 MCGPEN ( 675 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 6 1192001 108 MCGPEN ( 108 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
March 2018 Page 6 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name PEGINTRON
103949 0 7 1192001 1184 MCGVIAL ( 1184 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 8 1192001 162 MCGPEN ( 162 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 9 1192001 1776 MCGVIAL ( 1776 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 10 1192001 2025 MCGPEN ( 2025 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 11 1192001 222 MCGVIAL ( 222 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No PALATIN TECHNOLOGIES INC 1588
Trade Name NEUTROSPEC TECHNETIUM (99M TC)
Proper Name FANOLESOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103928 0 1 722004 025 MGVIAL ( 025 MGVIAL ) 09222008
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No RECORDATI RARE DISEASES INC 1899
Trade Name ELSPAR
Proper Name ASPARAGINASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
101063 0 1 1101978 10000 IU ( 10000 IUVIAL ) 04092014
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
March 2018 Page 7 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No SCHERING CORP 0994
Trade Name PEGINTRONREBETOL COMBO PACK
Proper Name PEGINTERFERON ALFA-2B AND RIBAVIRIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125196 0 1 6132008 ( 4 (120 MCG05ML) REDIPEN amp 140 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 2 6132008 ( 4 (150 MCG05ML) REDIPEN amp 168 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 3 6132008 ( 4 (150 MCG05ML) REDIPEN amp 196 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 4 6132008 ( 4 (50 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 5 6132008 ( 4 (80 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125422 0 2 10172012 05 MG ( 25 MGML ) 08082017
SOLUTION INTRAVETREAL SINGLE-DOSE VIAL
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125164 0 10 11142007 50 MCGML ( 50 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 8 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
125164 0 11 11142007 100 MCGML ( 100 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 12 11142007 200 MCGML ( 200 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 13 11142007 300 MCGML ( 300 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 14 11142007 400 MCGML ( 400 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 15 11142007 400 MCG06 ML ( 400 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 16 11142007 600 MCGML ( 600 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 17 11142007 600 MCG06 ML ( 600 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 18 11142007 800 MCG06 ML ( 800 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 19 11142007 1000 MCGML ( 1000 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 9 of 9
CDER Billable Biologic Product List
ApplicantLicense No AMGEN INC 1080
125320 0 1 612010 60 MGML ( 60 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name REPATHA
Proper Name EVOLOCUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125522 0 1 8272015 140 MGML ( 140 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125522 1 2 7112016 420 MG35 ML ( 120 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125522 0 3 8272015 140 MGML ( 140 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name VECTIBIX
Proper Name PANITUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125147 0 1 9272006 100 MG5 ML ( 20 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125147 0 2 9272006 200 MG10 ML ( 20 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125147 0 3 9272006 400 MG20 ML ( 20 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name XGEVA
Proper Name DENOSUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125320 7 2 11182010 120 MG17 ML ( 70 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 8 of 42
CDER Billable Biologic Product List
ApplicantLicense No ASTRAZENECA UK LTD 2043
Trade Name FASENRA
Proper Name BENRALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761070 0 1 11142017
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
30 MGML ( 30 MGML )
Trade Name
Proper Name
IMFINZI
DURVALUMAB
BLASTN
761069 0
Product
1
Approval Date
512017
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
120 MG24 ML ( 50 MGML )
761069 0 2 512017
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
500 MG10 ML ( 50 MGML )
ApplicantLicense No AUXILIUM PHARMACEUTICALS INC 1816
Trade Name XIAFLEX
Proper Name CLOSTRIDIAL COLLAGENASE HISTOLYTICUM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125338 0 1 222010 09 MG ( 09 MGVIAL )
POWDER INTRALESIONAL SINGLE-DOSE VIAL
ApplicantLicense No AYTU BIOSCIENCES INC 2035
Trade Name PROSTASCINT
Proper Name CAPROMAB PENDETIDE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103608 0 1 10281996 05 MGML ( 05 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 9 of 42
CDER Billable Biologic Product List
ApplicantLicense No BAXALTA US INC 2020
Trade Name ONCASPAR
Proper Name PEGASPARGASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103411 0 1 211994 3750 IU5 ML ( 750 IUML )
SOLUTION INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No BAYER HEALTHCARE PHARMACEUTICALS INC 1778
Trade Name BETASERON
Proper Name INTERFERON BETA-1B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103471 0 1 7231993 03 MG ( 03 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No BIOGEN INC 1697
Trade Name AVONEX
Proper Name INTERFERON BETA 1A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103628 0 1 5171996
POWDER INTRAMUSCULAR
30 MCG ( 30 MCGVIAL )
SINGLE-DOSE VIAL
103628 0 2 5171996
SOLUTION INTRAMUSCULAR PREFILLED SYRINGE
30 MCG05 ML ( 30 MCG05 ML )
103628 0 3 5171996
SOLUTION INTRAMUSCULAR AUTOINJECTOR
30 MCG05 ML ( 30 MCG05 ML )
Trade Name
Proper Name
BLASTN
125499 0
PLEGRIDY
PEGINTERFERON BETA-1A
Approval Date PotencyDosage FormRoutePresentation Product
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
63 MCG05 ML ( 126 MCGML ) 8152014 1
March 2018 Page 10 of 42
CDER Billable Biologic Product List
ApplicantLicense No BIOGEN INC 1697
125499 0 2 8152014 125 MCG05 ML ( 250 MCGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125499 0 3 8152014 63 MCG05 ML ( 126 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125499 0 4 8152014 94 MCG05 ML ( 188 MCGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125499 0 5 8152014 94 MCG05 ML ( 188 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125499 0 6 8152014 125 MCG05 ML ( 250 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name TYSABRI
Proper Name NATALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125104 0 1 11232004 300 MG15 ML ( 20 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name ZINBRYTA
Proper Name DACLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761029 0 1 5272016 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
761029 0 2 5272016 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 11 of 42
CDER Billable Biologic Product List
ApplicantLicense No BIOMARIN PHARMACEUTICAL INC 1649
Trade Name ALDURAZYME
Proper Name LARONIDASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125058 0 1 4302003
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
29 MG5 ML ( 058 MGML )
Trade Name
Proper Name
BRINEURA
CERLIPONASE ALFA
BLASTN
761052 0
Product
1
Approval Date
4272017
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENTRICULAR SINGLE-DOSE VIAL
150 MG5 ML ( 30 MGML )
Trade Name
Proper Name
NAGLAZYME
GALSULFASE
BLASTN
125117 0
Product
1
Approval Date
5312005
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
5 MG 5ML ( 1 MGML )
Trade Name
Proper Name
VIMIZIM
ELOSULFASE ALFA
BLASTN
125460 0
Product
1
Approval Date
2142014
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
5 MG5 ML ( 1 MGML )
ApplicantLicense No BOEHRINGER INGELHEIM PHARMACEUTICALS INC 2006
Trade Name PRAXBIND
Proper Name IDARUCIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761025 0 1 10162015 2500 MG50 ML ( 50 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 12 of 42
CDER Billable Biologic Product List
ApplicantLicense No BRISTOL MYERS SQUIBB CO 1713
Trade Name EMPLICITI
Proper Name ELOTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761035 0 1 11302015
POWDER INTRAVENOUS SINGLE-DOSE VIAL
300 MG ( 300 MGVIAL )
761035 0 2 11302015
POWDER INTRAVENOUS SINGLE-DOSE VIAL
400 MG ( 400 MGVIAL )
Trade Name
Proper Name
BLASTN
125288 0
NULOJIX
BELATACEPT
Approval Date Product
6152011 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
250 MG ( 250 MGVIAL )
Trade Name
Proper Name
BLASTN
125554 0
OPDIVO
NIVOLUMAB
Approval Date Product
12222014 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
40 MG4 ML ( 10 MGML )
125554 0 2 12222014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG10 ML ( 10 MGML )
125554 0 3 12222014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
240 MG24 ML ( 10 MGML )
Trade Name
Proper Name
BLASTN
125118 0
ORENCIA
ABATACEPT
Approval Date Product
12232005 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
250 MG ( 250 MGVIAL )
March 2018 Page 13 of 42
CDER Billable Biologic Product List
ApplicantLicense No BRISTOL MYERS SQUIBB CO 1713
125118 122 2 7292011 50 MG04 ML ( 125 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125118 122 3 7292011 875 MG07 ML ( 125 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125118 122 4 7292011 125 MGML ( 125 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125118 122 5 7292011 125 MGML ( 125 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name YERVOY
Proper Name IPILIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125377 0 1 3252011 50 MG10 ML ( 5 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125377 0 2 3252011 200 MG40 ML ( 5 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No BTG INTERNATIONAL INC 1861
Trade Name VORAXAZE
Proper Name GLUCARPIDASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125327 0 1 1172012 1000 U ( 1000 UVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 14 of 42
CDER Billable Biologic Product List
ApplicantLicense No DYAX CORPORATION 1789
Trade Name KALBITOR
Proper Name ECALLANTIDE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125277 0 1 1212009 10 MGML ( 10 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No EKR THERAPEUTICS INC 1814
Trade Name RETAVASE
Proper Name RETEPLASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103786 0 1 561998 10 U ( 10 UVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No ELI LILLY AND CO 1891
Trade Name CYRAMZA
Proper Name RAMUCIRUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125477 0 1 4212014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG10 ML ( 10 MGML )
125477 0 2 4212014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
500 MG50 ML ( 10 MGML )
Trade Name
Proper Name
BLASTN
761038 0
LARTRUVO
OLARATUMAB
Approval Date Product
10192016 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
500 MG50 ML ( 10 MGML )
761038 0 2 10192016
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
190 MG19 ML ( 10 MGML )
March 2018 Page 15 of 42
CDER Billable Biologic Product List
ApplicantLicense No ELI LILLY AND CO 1891
Trade Name PORTRAZZA
Proper Name NECITUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125547 0 1 11242015
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
800 MG50 ML ( 16 MGML )
Trade Name
Proper Name
TALTZ
IXEKIZUMAB
BLASTN
125521 0
Product
1
Approval Date
3222016
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
80 MGML ( 80 MGML )
125521 0 2 3222016
SOLUTION SUBCUTANEOUS AUTOINJECTOR
80 MGML ( 80 MGML )
Trade Name
Proper Name
TRULICITY
DULAGLUTIDE
BLASTN
125469 0
Product
1
Approval Date
9182014
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
075 MG05 ML ( 075 MG05 ML )
125469 0 2 9182014
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
15 MG05 ML ( 15 MG05 ML )
125469 0 3 9182014
SOLUTION SUBCUTANEOUS AUTOINJECTOR
075 MG05 ML ( 075 MG05 ML )
125469 0 4 9182014
SOLUTION SUBCUTANEOUS AUTOINJECTOR
15 MG05 ML ( 15 MG05 ML )
March 2018 Page 16 of 42
CDER Billable Biologic Product List
ApplicantLicense No ELUSYS THERAPEUTICS INC 1907
Trade Name ANTHIM
Proper Name OBILTOXAXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125509 1 1 3182016 600 MG6 ML ( 100 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No EMD SERONO INC 1773
Trade Name BAVENCIO
Proper Name AVELUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761049 0 1 3232017
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
200 MG10 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
103780 0
REBIF
INTERFERON BETA 1A
Approval Date Product
372002 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
88 MCG02 ML ( 44 MCGML )
103780 0 2 372002
SOLUTION SUBCUTANEOUS AUTOINJECTOR
88 MCG02 ML ( 44 MCGML )
103780 0 3 372002
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
22 MCG05 ML ( 44 MCGML )
103780 0 4 372002
SOLUTION SUBCUTANEOUS AUTOINJECTOR
22 MCG05 ML ( 44 MCGML )
103780 0 5 372002
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
44 MCG05 ML ( 88 MCGML )
103780 0 6 372002
SOLUTION SUBCUTANEOUS AUTOINJECTOR
44 MCG05 ML ( 88 MCGML )
March 2018 Page 17 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name ACTEMRA
Proper Name TOCILIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125276 0 1 182010
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
80 MG4 ML ( 20 MGML )
125276 0 2 182010
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
200 MG10 ML ( 20 MGML )
125276 0 3 182010
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
400 MG20 ML ( 20 MGML )
BLASTN
125472 1
Product
1
Approval Date
10212013
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
162 MG09 ML ( 179 MGML )
Trade Name
Proper Name
BLASTN
103172 0
ACTIVASE
ALTEPLASE
Approval Date Product
11131987 2
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
50 MG ( 50 MGVIAL )
103172 0 3 11131987
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
BLASTN
125085 0
AVASTIN
BEVACIZUMAB
Approval Date Product
2262004 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG4 ML ( 25 MGML )
125085 0 2 2262004
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
400 MG16 ML ( 25 MGML )
March 2018 Page 18 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name CATHFLO ACTIVASE
Proper Name ALTEPLASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103172 0 1 11131987
POWDER INTRACATHETER SINGLE-DOSE VIAL
2 MG ( 2 MGVIAL )
Trade Name
Proper Name
BLASTN
125486 0
GAZYVA
OBINUYUZUMAB
Approval Date Product
1112013 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1000 MG40 ML ( 25 MGML )
Trade Name
Proper Name
BLASTN
761083 0
HEMLIBRA
EMICIZUMAB-KXWH
Approval Date Product
11162017 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML )
761083 0 2 11162017
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
60 MG04 ML ( 150 MGML )
761083 0 3 11162017
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
105 MG07 ML ( 150 MGML )
761083 0 4 11162017
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
150 MGML ( 150 MGML )
Trade Name
Proper Name
BLASTN
103792 0
HERCEPTIN
TRASTUZUMAB
Approval Date Product
9251998 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS MULTI-DOSE VIAL
420 MG ( 420 MGVIAL )
March 2018 Page 19 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
103792 5336 2 2102017 150 MG ( 150 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name KADCYLA
Proper Name ADO-TRASIUZUMAB EMTANSINE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125427 0 1 2222013
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
125427 0 2 2222013
POWDER INTRAVENOUS SINGLE-DOSE VIAL
160 MG ( 160 MGVIAL )
Trade Name
Proper Name
LUCENTIS
RANIBIZUMAB
BLASTN
125156 0
Product
1
Approval Date
6302006
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE
05 MG005 ML ( 10 MGML )
Proper Name RANIDIZUMAB
BLASTN
125156 076
Product
2
Approval Date
8102012
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE
03 MG005 ML ( 6 MGML )
Trade Name
Proper Name
OCREVUS
OCRELIZUMAB
BLASTN
761053 0
Product
1
Approval Date
3282017
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
300 MG10 ML ( 30 MGML )
Trade Name
Proper Name
PERJETA
PERTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 20 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
125409 0 1 682012 420 MG14 ML ( 30 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name PULMOZYME
Proper Name DORNASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103532 0 1 12301993 25 MG25 ML ( 1 MGML )
SOLUTION INHALATION AMPULE
Trade Name RITUXAN
Proper Name RITUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103705 0 1 11261997 100 MG10 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
103705 0 2 11261997 500 MG50 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name RITUXAN HYCELA
Proper Name RITUXIMAB AND HYALURONIDASE HUMAN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761064 0 1 6222017 1400 MG AND 23400 U117 ML ( 11966 MG AND 2000 UML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
761064 0 2 6222017 1600 MG AND 26800 U134 ML ( 11966 MG AND 2000 UML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name TECENTRIQ
Proper Name ATEZOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761034 0 1 582016 1200 MG20 ML ( 60 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name TNKASE
March 2018 Page 21 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Proper Name TENECTEPLASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103909 0 1 622000 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103976 0 1 6202003 150 MG ( 150 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103948 0 1 572001
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML )
Trade Name
Proper Name
FABRAZYME
AGALSIDASE BETA
BLASTN
103979 0
Product
1
Approval Date
4242003
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
5 MG ( 5 MGVIAL )
103979 0 2 4242003
POWDER INTRAVENOUS SINGLE-DOSE VIAL
35 MG ( 35 MGVIAL )
Trade Name
Proper Name
LEMTRADA
ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 22 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENZYME CORP 1596
103948 5139 2 11142014 12 MG12 ML ( 10MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name LUMIZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125291 0 1 5242010 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name NUCALA
Proper Name MEPOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125526 0 1 11142015
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
TANZEUM
ALBIGLUTIDE
BLASTN
125431 0
Product
1
Approval Date
4152014
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS AUTOINJECTOR
30 MG ( 30 MGAUTOINJECTOR )
125431 0 2 4152014
POWDER SUBCUTANEOUS AUTOINJECTOR
50 MG ( 50 MGAUTOINJECTOR )
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name PEGASYS
Proper Name PEGINTERFERON ALFA 2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103964 5204 4 9292011 180 MCG05 ML ( 360 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 23 of 42
CDER Billable Biologic Product List
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Proper Name PEG-INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103964 0 1 10162002 180 MCGML ( 180 MCGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
103964 0 2 10162002 180 MCG05 ML ( 360 MCGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
103964 5204 3 9292011 135 MCG05 ML ( 270 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
ApplicantLicense No HORIZON PHARMA IRELAND LTD 2022
Trade Name ACTIMMUNE
Proper Name INTERFERON GAMMA-1B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103836 0 1 2251999 100 MCG05 ML ( 200 MCGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No HORIZON PHARMA RHEUMATOLOGY LLC 1998
Trade Name KRYSTEXXA
Proper Name PEGLOTICASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125293 0 1 9142010 8MGML ( 8MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 24 of 42
CDER Billable Biologic Product List
ApplicantLicense No HUMAN GENOME SCIENCES INC 1820
Trade Name BENLYSTA
Proper Name BELIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125370 0 1 392011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
120 MG ( 120 MGVIAL )
125370 0 2 392011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
400 MG ( 400 MGVIAL )
125370 0 3 392011
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )
125370 0 4 392011
SOLUTION SUBCUTANEOUS AUTOINJECTOR
200 MGML ( 200 MGML )
BLASTN
761043 0
Product
1
Approval Date
7202017
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )
Trade Name
Proper Name
RAXIBACUMAB
RAXIBACUMAB
BLASTN
125349 0
Product
1
Approval Date
12142012
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1700 MG34 ML ( 50 MGML )
ApplicantLicense No IMCLONE LLC 1695
Trade Name ERBITUX
Proper Name CETUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125084 0 1 2122004 100 MG50 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 25 of 42
CDER Billable Biologic Product List
ApplicantLicense No IMCLONE LLC 1695
125084 0 2 2122004 200 MG100 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No IMMUNEX CORP 1132
Trade Name ENBREL
Proper Name ETANERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103795 0 1 1121998
POWDER SUBCUTANEOUS MULTI-DOSE VIAL
25 MG ( 25 MGVIAL )
103795 5184 2 9272004
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
50 MGML ( 50 MGML )
103795 0 3 9272004
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MGML ( 50 MGML )
103795 5184 4 9272004
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
25 MG05 ML ( 50 MGML )
103795 5556 5 9142017
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MGML ( 50 MGML )
ApplicantLicense No IPSEN BIOPHARM LIMITED 1787
Trade Name DYSPORT
Proper Name ABOBOTULINUMTOXINA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125274 0 1 4292009
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
300 UNITS ( 300 UNITSVIAL )
125274 0 2 4292009
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
500 UNITS ( 500 UNITSVIAL )
March 2018 Page 26 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
Trade Name DARZALEX
Proper Name DARATUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761036 0 1 11162015
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG5 ML ( 20 MGML )
761036 0 2 11162015
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
400 MG20 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
103772 0
REMICADE
INFLIXIMAB
Approval Date Product
8241998 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
BLASTN
103575 0
REOPRO
ABCIXIMAB
Approval Date Product
12221994 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
10 MG5 ML ( 2 MGML )
Trade Name
Proper Name
BLASTN
125289 0
SIMPONI
GOLIMUMAB
Approval Date Product
4242009 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
50 MG05 ML ( 100 MGML )
125289 0 2 4242009
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MG05 ML ( 100 MGML )
125289 0 3 4242009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
100 MGML ( 100 MGML )
March 2018 Page 27 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
125289 0 4 4242009 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name SIMPONI ARIA
Proper Name GOLIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125433 0 1 7182013 50 MG4 ML ( 125 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name STELARA
Proper Name USTEKINUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125261 0 1 9252009 90 MGML ( 90 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125261 0 2 9252009 45 MG05 ML ( 90 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL amp PREFILLED SYRINGE
125261 0 3 9252009 130 MG26 ML ( 5 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761044 0 1 9232016 130 MG26 ML ( 5 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SYLVANT
Proper Name SILTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125496 0 1 4232014 100 MG ( 100 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125496 0 2 4232014 400 MG ( 400 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 28 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
Trade Name TREMFYA
Proper Name GUSELKUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761061 0 1 7132017 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No JAZZ PHARMACEUTICALS INC 1901
Trade Name ERWINAZE
Proper Name ASPARAGINASE ERWINIA CHRYSANTHEMI
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
105359 0 1 11182011 10000 IU ( 10000 IUVIAL )
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103770 0 1 6191998
SOLUTION INTRAMUSCULAR
50 MG05 ML ( 100 MGML )
SINGLE-DOSE VIAL
103770 0 2 6191998
SOLUTION INTRAMUSCULAR
100 MGML ( 100 MGML )
SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name ILUMYA
Proper Name TILDRAKIZUMAB-ASMN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761067 0 1 3202018 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name INTRON A
March 2018 Page 29 of 42
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103132 0 1 641986 10 MIU ( 10 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL INTRAVENOUS SINGLE-DOSE VIAL
103132 0 2 641986 18 MIU ( 18 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL
103132 0 3 641986 50 MIU ( 50 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL
103132 0 4 641986 228 MIU38 ML ( 6 MIUML )
SOLUTION INTRAMUSCULAR SUBCUTANEOUS MULTI-DOSE VIAL
103132 0 5 641986 32 MIU32 ML ( 10 MIUML )
SOLUTION INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL MULTI-DOSE VIAL
Trade Name KEYTRUDA
Proper Name PEMBROLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125514 0 1 942014 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125514 1 2 1152015 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 0 1 1192001 74 MCG ( 74 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SYLATRON
Proper Name PEGINTERFERON ALFA-2B
March 2018 Page 30 of 42
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 5153 2 3292011 296 MCG ( 296 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 3 3292011 444 MCG ( 444 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 4 3292011 888 MCG ( 888 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name ZINPLAVA
Proper Name BEZLOTOXUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761046 0 1 10212016 1000 MG40 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No MERZ PHARMACEUTICALS GMBH 1830
Trade Name XEOMIN
Proper Name INCOBOTULINUMTOXINA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125360 0 1 7302010
POWDER INTRAMUSCULAR
50 U ( 50 UVIAL )
SINGLE-DOSE VIAL
125360 0 2 7302010
POWDER INTRAMUSCULAR
100 U ( 100 UVIAL )
SINGLE-DOSE VIAL
125360 3 3 11202015
POWDER INTRAMUSCULAR
200 U ( 200 UVIAL )
SINGLE-DOSE VIAL
March 2018 Page 31 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
Trade Name ARZERRA
Proper Name OFATUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125326 0 1 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG5 ML ( 20 MGML )
125326 0 2 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1000 MG50 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
125504 0
COSENTYX
SECUKINUMAB
Approval Date Product
1212015 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
150 MG ( 150 MGVIAL )
125504 0 2 1212015
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MGML ( 150 MGML )
125504 0 3 1212015
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MGML ( 150 MGML )
Trade Name
Proper Name
BLASTN
125290 0
EXTAVIA
INTERFERON BETA-1B
Approval Date Product
8142009 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
03 MG ( 03 MGVIAL )
Trade Name
Proper Name
BLASTN
125319 0
ILARIS
CANAKINUMAB
Approval Date Product
6172009 1
PotencyDosage FormRoutePresentation
180 MGVIAL ( 180 MGVIAL )
March 2018 Page 32 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
125319 88 2 12222016 150 MG ( 150 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
125319 0 3 12222016 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SIMULECT
Proper Name BASILIXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103764 0 1 5121998 10 MG ( 10 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
103764 0 2 5121998 20 MG ( 20 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No NPS PHARMACEUTICALS INC 1908
Trade Name NATPARA
Proper Name PARATHYROID HORMONE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 33 of 42
CDER Billable Biologic Product List
ApplicantLicense No PROMETHEUS LABORATORIES INC 1848
Trade Name PROLEUKIN
Proper Name ALDESLEUKIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103293 0 1 551992 22 MIU ( 22 MIUVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760
Trade Name ARCALYST
Proper Name RILONACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125249 0 1 2272008
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
220MG ( 220MGVIAL )
Trade Name
Proper Name
DUPIXENT
DUPILUMAB
BLASTN
761055 0
Product
1
Approval Date
3282017
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
300 MG2 ML ( 150 MGML )
Trade Name
Proper Name
EYLEA
AFLIBERCEPT
BLASTN
125387 0
Product
1
Approval Date
11182011
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
2 MG005 ML ( 40 MGML )
March 2018 Page 34 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Trade Name ELITEK
Proper Name RASBURICASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103946 0 1 7122002
POWDER INTRAVENOUS SINGLE-DOSE VIAL
15 MG ( 15 MGVIAL )
103946 5020 2 162006
POWDER INTRAVENOUS SINGLE-DOSE VIAL
75 MG ( 75 MGVIAL )
Trade Name
Proper Name
BLASTN
761037 0
KEVZARA
SARILUMAB
Approval Date Product
5222017 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MG114 ML ( 13158 MGML )
761037 0 2 5222017
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MG114 ML ( 17544 MGML )
761037 1 3 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MG114 ML ( 13158 MGML )
761037 1 4 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
200 MG114 ML ( 17544 MGML )
Trade Name
Proper Name
BLASTN
103362 0
LEUKINE
SARGRAMOSTIM
Approval Date Product
351991 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
250 MCG ( 250 MCGVIAL )
103362 0 2 351991
SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL
500 MCGML ( 500 MCGML )
Trade Name PRALUENT
March 2018 Page 35 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Proper Name ALIROCUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125559 0 1 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 2 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 3 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125559 0 4 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name ZALTRAP
Proper Name ZIV-AFLIBERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125418 0 1 832012 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125418 0 2 832012 200 MG8 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SEATTLE GENETICS INC 1853
Trade Name ADCETRIS
Proper Name BRENTUXIMAB VEDOTIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125388 1 1 8192011 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 36 of 42
CDER Billable Biologic Product List
ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593
Trade Name ELAPRASE
Proper Name IDURSULFASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125151 0 1 7242006 6 MG3 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SICOR BIOTECH UAB 1803
Trade Name GRANIX
Proper Name TBO-FILGRASTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125294 0 1 8292012
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
300 MCG0 5 ML ( 600 MCGML )
125294 0 2 8292012
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
480 MCG08 ML ( 600 MCGML )
ApplicantLicense No SMITH AND NEPHEW INC 2004
Trade Name REGRANEX
Proper Name BECAPLERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103691 0 1 12161997
GEL TOPICAL
100 UG ( 100 UGGM )
Trade Name
Proper Name
SANTYL
COLLAGENASE
BLASTN
101995 0
Product
1
Approval Date
641965
PotencyDosage FormRoutePresentation
OINTMENT TOPICAL
30 G amp 90 G TUBE ( 250 UGRAM )
March 2018 Page 37 of 42
CDER Billable Biologic Product List
ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718
Trade Name MYOBLOC
Proper Name RIMABOTULINUM TOXIN B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103846 0 1 1282002
SOLUTION INTRAMUSCULAR
2500 IU05 ML ( 5000 IUML )
SINGLE-DOSE VIAL
103846 0 3 1282002
SOLUTION INTRAMUSCULAR
10000 IU2 ML ( 5000 IUML )
SINGLE-DOSE VIAL
Proper Name RIMABOTULINUMTOXINB
BLASTN
103846 0
Product
2
Approval Date
1282002
PotencyDosage FormRoutePresentation
SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL
5000 IUML ( 5000 IUML )
ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832
Trade Name ZEVALIN
Proper Name IBRITUMOMAB TIUXETAN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125019 0 1 2192002 32 MG2 ML ( 16 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
Trade Name KEPIVANCE
Proper Name PALIFERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125103 0 1 12152004 625 MG ( 625 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name KINERET
Proper Name ANAKINRA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 38 of 42
CDER Billable Biologic Product List
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898
Trade Name ENTYVIO
Proper Name VEDOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125476 0 1 5202014 300 MG ( 300 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No TEVA RESPIRATORY LLC 2047
Trade Name CINQAIR
Proper Name RESLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761033 0 1 3232016 100 MG10 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No THERATECHNOLOGIES INC 2091
Trade Name TROGARZO
Proper Name IBALIZUMAB-UIYK
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761065 0 1 362018 200 MG133 ML ( 150 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 39 of 42
CDER Billable Biologic Product List
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
0375 MG03 ML ( 125 MGML )2222017 125422 038 1
ApplicantLicense No UCB INC 1736
Trade Name CIMZIA
Proper Name CERTOLIZUMAB PEGOL
BLASTN Approval Date PotencyDosage FormRoutePresentation Product
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
200 MG ( 200 MGVIAL ) 4222008 125160 0 1
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )5132009 125160 080 2
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
Trade Name CRYSVITA
Proper Name BUROSUMAB-TWZA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761068 0 1 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
10 MGML ( 10 MGML )
761068 0 2 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
20 MGML ( 20 MGML )
761068 0
Trade Name
Proper Name
BLASTN
March 2018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML ) 4172018 3
MEPSEVII
VESTRONIDASE ALFA-VJBK
Approval Date PotencyDosage FormRoutePresentation Product
Page 40 of 42
CDER Billable Biologic Product List
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
761047 0 1 11152017 10 MG5 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No UNITED THERAPEUTICS CORP 1993
Trade Name UNITUXIN
Proper Name DINUTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125516 0 1 3102015 175 MG5 ML ( 35 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053
Trade Name SILIQ
Proper Name BRODALUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761032 0 1 2152017 210 MG15 ML ( 140 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 41 of 42
CDER Billable Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No WYETH PHARMACEUTICALS INC 0003
Trade Name BESPONSA
Proper Name INOTUZUMAB OZOGAMICIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761040 0 1 8172017 09 MG ( 09 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 42 of 42
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 1 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
9172001 103951 0 26
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
200 MCGML ( 200 MCGML ) 09272012
103951 0 27 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
200 MCG04 ML ( 500 MCGML ) 09272012
103951 0 28 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
300 MCGML ( 300 MCGML ) 09272012
103951 0 29 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
300 MCG06 ML ( 500 MCGML ) 09272012
103951 0 30 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
500 MCGML ( 500 MCGML ) 09272012
ApplicantLicense No ASTELLAS PHARMACEUTICALS US INC 1748
Trade Name AMEVIVE
Proper Name ALEFACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125036 0 1 1302003 75 MGVIAL ( 75 MGVIAL ) 09242008
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
125036 0 2 1302003 15 MGVIAL ( 15 MGVIAL ) 09282012
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No BOEHRINGER INGELHEIM PHARMA KG 1251
Trade Name VERLUMA
Proper Name NOFETUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103769 0 1 10131998 10 MGML ( 10 MGML ) 08132013
INTRAVENOUS
March 2018 Page 2 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No CENTOCOR ORTHO BIOTECH PRODUCTS LP 1824
Trade Name ORTHOCLONE OKT3
Proper Name MUROMONAB-CD3
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103463 0 1 9141992 1 MGML ( 1 MGML ) 01112012
SOLUTION INTRAVENOUS AMPULE
ApplicantLicense No EISAI INCORPORATED 1862
Trade Name ONTAK
Proper Name DENILEUKIN DIFTITOX
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103767 0 1 251999 300 MCG2 ML ( 150 MCGML ) 01302014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No ELI LILLY AND CO 1611
Trade Name XIGRIS
Proper Name DROTRECOGIN ALFA (ACTIVATED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125029 0 1 11212001 5 MGVIAL ( 5 MGVIAL ) 10262011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125029 0 2 11212001 20 MGVIAL ( 20 MGVIAL ) 10102011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GENENTECH INC 1048
Trade Name RAPTIVA
Proper Name EFALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125075 0 1 10272003 125 MGVIAL ( 125 MGVIAL ) 09012009
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
March 2018 Page 3 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103976 0 2 6202003 125 MGVIAL ( 125 MGVIAL ) 08252016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103948 0 3 572001 10 MGVIAL ( 10 MGVIAL ) 07062011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name MYOZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125141 0 1 4282006 50 MGVIAL ( 50 MGVIAL ) 10172014
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name BEXXAR THERAPEUTIC REGIME
Proper Name TOSITUMOMAB AND IODINE I-131 TOSITUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125011 0 1 6272003 01 MGML I-131 TOSITUMOMAB ( 01 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 2 6272003 11 MGML I-131 TOSITUMOMAB ( 11 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 3 6272003 14 MGML TOSITUMOMAB ( 14 MGML 03102014 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 4 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No HEMISPHERX BIOPHARMA INC 1703
Trade Name ALFERON N INJECTION
Proper Name INTERFERON ALFA-N3 (HUMAN LEUKOCYTE DERIVED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103158 0 1 10101989 5 MIUVIAL ( 5 MIUVIAL ) 06272013
SOLUTION INTRALESIONAL MULTI-DOSE VIAL
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name ROFERON A
Proper Name INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103145 0 1 641986 3 MIU05 ML ( 3 MIU05 ML ) 06012009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name ZENAPAX
Proper Name DACLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103749 0 1 12101997 25 MG5 ML ( 25 MG5 ML ) 07072011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No KADMON PHARMACEUTICALS LLC 1867
Trade Name INFERGEN
Proper Name INTERFERON ALFACON-1
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103663 0 1 1061997 9 MCG03 ML ( 30 MCGML ) 07252013
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 5 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103770 0 3 6191998 50 MGVIAL ( 50 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
103770 0 4 6191998 100 MGVIAL ( 100 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name INTRON A
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103132 0 6 641986 10 MIUML ( 10 MIUML ) 09232013
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103132 0 7 641986 225 MIU15 ML ( 225 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 8 641986 375 MIU15 ML ( 375 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 9 641986 75 MIU15 ML ( 75 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103949 0 5 1192001 675 MCGPEN ( 675 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 6 1192001 108 MCGPEN ( 108 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
March 2018 Page 6 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name PEGINTRON
103949 0 7 1192001 1184 MCGVIAL ( 1184 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 8 1192001 162 MCGPEN ( 162 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 9 1192001 1776 MCGVIAL ( 1776 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 10 1192001 2025 MCGPEN ( 2025 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 11 1192001 222 MCGVIAL ( 222 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No PALATIN TECHNOLOGIES INC 1588
Trade Name NEUTROSPEC TECHNETIUM (99M TC)
Proper Name FANOLESOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103928 0 1 722004 025 MGVIAL ( 025 MGVIAL ) 09222008
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No RECORDATI RARE DISEASES INC 1899
Trade Name ELSPAR
Proper Name ASPARAGINASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
101063 0 1 1101978 10000 IU ( 10000 IUVIAL ) 04092014
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
March 2018 Page 7 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No SCHERING CORP 0994
Trade Name PEGINTRONREBETOL COMBO PACK
Proper Name PEGINTERFERON ALFA-2B AND RIBAVIRIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125196 0 1 6132008 ( 4 (120 MCG05ML) REDIPEN amp 140 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 2 6132008 ( 4 (150 MCG05ML) REDIPEN amp 168 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 3 6132008 ( 4 (150 MCG05ML) REDIPEN amp 196 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 4 6132008 ( 4 (50 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 5 6132008 ( 4 (80 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125422 0 2 10172012 05 MG ( 25 MGML ) 08082017
SOLUTION INTRAVETREAL SINGLE-DOSE VIAL
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125164 0 10 11142007 50 MCGML ( 50 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 8 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
125164 0 11 11142007 100 MCGML ( 100 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 12 11142007 200 MCGML ( 200 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 13 11142007 300 MCGML ( 300 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 14 11142007 400 MCGML ( 400 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 15 11142007 400 MCG06 ML ( 400 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 16 11142007 600 MCGML ( 600 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 17 11142007 600 MCG06 ML ( 600 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 18 11142007 800 MCG06 ML ( 800 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 19 11142007 1000 MCGML ( 1000 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 9 of 9
CDER Billable Biologic Product List
ApplicantLicense No ASTRAZENECA UK LTD 2043
Trade Name FASENRA
Proper Name BENRALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761070 0 1 11142017
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
30 MGML ( 30 MGML )
Trade Name
Proper Name
IMFINZI
DURVALUMAB
BLASTN
761069 0
Product
1
Approval Date
512017
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
120 MG24 ML ( 50 MGML )
761069 0 2 512017
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
500 MG10 ML ( 50 MGML )
ApplicantLicense No AUXILIUM PHARMACEUTICALS INC 1816
Trade Name XIAFLEX
Proper Name CLOSTRIDIAL COLLAGENASE HISTOLYTICUM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125338 0 1 222010 09 MG ( 09 MGVIAL )
POWDER INTRALESIONAL SINGLE-DOSE VIAL
ApplicantLicense No AYTU BIOSCIENCES INC 2035
Trade Name PROSTASCINT
Proper Name CAPROMAB PENDETIDE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103608 0 1 10281996 05 MGML ( 05 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 9 of 42
CDER Billable Biologic Product List
ApplicantLicense No BAXALTA US INC 2020
Trade Name ONCASPAR
Proper Name PEGASPARGASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103411 0 1 211994 3750 IU5 ML ( 750 IUML )
SOLUTION INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No BAYER HEALTHCARE PHARMACEUTICALS INC 1778
Trade Name BETASERON
Proper Name INTERFERON BETA-1B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103471 0 1 7231993 03 MG ( 03 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No BIOGEN INC 1697
Trade Name AVONEX
Proper Name INTERFERON BETA 1A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103628 0 1 5171996
POWDER INTRAMUSCULAR
30 MCG ( 30 MCGVIAL )
SINGLE-DOSE VIAL
103628 0 2 5171996
SOLUTION INTRAMUSCULAR PREFILLED SYRINGE
30 MCG05 ML ( 30 MCG05 ML )
103628 0 3 5171996
SOLUTION INTRAMUSCULAR AUTOINJECTOR
30 MCG05 ML ( 30 MCG05 ML )
Trade Name
Proper Name
BLASTN
125499 0
PLEGRIDY
PEGINTERFERON BETA-1A
Approval Date PotencyDosage FormRoutePresentation Product
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
63 MCG05 ML ( 126 MCGML ) 8152014 1
March 2018 Page 10 of 42
CDER Billable Biologic Product List
ApplicantLicense No BIOGEN INC 1697
125499 0 2 8152014 125 MCG05 ML ( 250 MCGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125499 0 3 8152014 63 MCG05 ML ( 126 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125499 0 4 8152014 94 MCG05 ML ( 188 MCGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125499 0 5 8152014 94 MCG05 ML ( 188 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125499 0 6 8152014 125 MCG05 ML ( 250 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name TYSABRI
Proper Name NATALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125104 0 1 11232004 300 MG15 ML ( 20 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name ZINBRYTA
Proper Name DACLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761029 0 1 5272016 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
761029 0 2 5272016 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 11 of 42
CDER Billable Biologic Product List
ApplicantLicense No BIOMARIN PHARMACEUTICAL INC 1649
Trade Name ALDURAZYME
Proper Name LARONIDASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125058 0 1 4302003
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
29 MG5 ML ( 058 MGML )
Trade Name
Proper Name
BRINEURA
CERLIPONASE ALFA
BLASTN
761052 0
Product
1
Approval Date
4272017
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENTRICULAR SINGLE-DOSE VIAL
150 MG5 ML ( 30 MGML )
Trade Name
Proper Name
NAGLAZYME
GALSULFASE
BLASTN
125117 0
Product
1
Approval Date
5312005
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
5 MG 5ML ( 1 MGML )
Trade Name
Proper Name
VIMIZIM
ELOSULFASE ALFA
BLASTN
125460 0
Product
1
Approval Date
2142014
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
5 MG5 ML ( 1 MGML )
ApplicantLicense No BOEHRINGER INGELHEIM PHARMACEUTICALS INC 2006
Trade Name PRAXBIND
Proper Name IDARUCIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761025 0 1 10162015 2500 MG50 ML ( 50 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 12 of 42
CDER Billable Biologic Product List
ApplicantLicense No BRISTOL MYERS SQUIBB CO 1713
Trade Name EMPLICITI
Proper Name ELOTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761035 0 1 11302015
POWDER INTRAVENOUS SINGLE-DOSE VIAL
300 MG ( 300 MGVIAL )
761035 0 2 11302015
POWDER INTRAVENOUS SINGLE-DOSE VIAL
400 MG ( 400 MGVIAL )
Trade Name
Proper Name
BLASTN
125288 0
NULOJIX
BELATACEPT
Approval Date Product
6152011 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
250 MG ( 250 MGVIAL )
Trade Name
Proper Name
BLASTN
125554 0
OPDIVO
NIVOLUMAB
Approval Date Product
12222014 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
40 MG4 ML ( 10 MGML )
125554 0 2 12222014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG10 ML ( 10 MGML )
125554 0 3 12222014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
240 MG24 ML ( 10 MGML )
Trade Name
Proper Name
BLASTN
125118 0
ORENCIA
ABATACEPT
Approval Date Product
12232005 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
250 MG ( 250 MGVIAL )
March 2018 Page 13 of 42
CDER Billable Biologic Product List
ApplicantLicense No BRISTOL MYERS SQUIBB CO 1713
125118 122 2 7292011 50 MG04 ML ( 125 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125118 122 3 7292011 875 MG07 ML ( 125 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125118 122 4 7292011 125 MGML ( 125 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125118 122 5 7292011 125 MGML ( 125 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name YERVOY
Proper Name IPILIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125377 0 1 3252011 50 MG10 ML ( 5 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125377 0 2 3252011 200 MG40 ML ( 5 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No BTG INTERNATIONAL INC 1861
Trade Name VORAXAZE
Proper Name GLUCARPIDASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125327 0 1 1172012 1000 U ( 1000 UVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 14 of 42
CDER Billable Biologic Product List
ApplicantLicense No DYAX CORPORATION 1789
Trade Name KALBITOR
Proper Name ECALLANTIDE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125277 0 1 1212009 10 MGML ( 10 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No EKR THERAPEUTICS INC 1814
Trade Name RETAVASE
Proper Name RETEPLASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103786 0 1 561998 10 U ( 10 UVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No ELI LILLY AND CO 1891
Trade Name CYRAMZA
Proper Name RAMUCIRUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125477 0 1 4212014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG10 ML ( 10 MGML )
125477 0 2 4212014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
500 MG50 ML ( 10 MGML )
Trade Name
Proper Name
BLASTN
761038 0
LARTRUVO
OLARATUMAB
Approval Date Product
10192016 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
500 MG50 ML ( 10 MGML )
761038 0 2 10192016
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
190 MG19 ML ( 10 MGML )
March 2018 Page 15 of 42
CDER Billable Biologic Product List
ApplicantLicense No ELI LILLY AND CO 1891
Trade Name PORTRAZZA
Proper Name NECITUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125547 0 1 11242015
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
800 MG50 ML ( 16 MGML )
Trade Name
Proper Name
TALTZ
IXEKIZUMAB
BLASTN
125521 0
Product
1
Approval Date
3222016
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
80 MGML ( 80 MGML )
125521 0 2 3222016
SOLUTION SUBCUTANEOUS AUTOINJECTOR
80 MGML ( 80 MGML )
Trade Name
Proper Name
TRULICITY
DULAGLUTIDE
BLASTN
125469 0
Product
1
Approval Date
9182014
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
075 MG05 ML ( 075 MG05 ML )
125469 0 2 9182014
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
15 MG05 ML ( 15 MG05 ML )
125469 0 3 9182014
SOLUTION SUBCUTANEOUS AUTOINJECTOR
075 MG05 ML ( 075 MG05 ML )
125469 0 4 9182014
SOLUTION SUBCUTANEOUS AUTOINJECTOR
15 MG05 ML ( 15 MG05 ML )
March 2018 Page 16 of 42
CDER Billable Biologic Product List
ApplicantLicense No ELUSYS THERAPEUTICS INC 1907
Trade Name ANTHIM
Proper Name OBILTOXAXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125509 1 1 3182016 600 MG6 ML ( 100 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No EMD SERONO INC 1773
Trade Name BAVENCIO
Proper Name AVELUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761049 0 1 3232017
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
200 MG10 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
103780 0
REBIF
INTERFERON BETA 1A
Approval Date Product
372002 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
88 MCG02 ML ( 44 MCGML )
103780 0 2 372002
SOLUTION SUBCUTANEOUS AUTOINJECTOR
88 MCG02 ML ( 44 MCGML )
103780 0 3 372002
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
22 MCG05 ML ( 44 MCGML )
103780 0 4 372002
SOLUTION SUBCUTANEOUS AUTOINJECTOR
22 MCG05 ML ( 44 MCGML )
103780 0 5 372002
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
44 MCG05 ML ( 88 MCGML )
103780 0 6 372002
SOLUTION SUBCUTANEOUS AUTOINJECTOR
44 MCG05 ML ( 88 MCGML )
March 2018 Page 17 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name ACTEMRA
Proper Name TOCILIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125276 0 1 182010
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
80 MG4 ML ( 20 MGML )
125276 0 2 182010
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
200 MG10 ML ( 20 MGML )
125276 0 3 182010
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
400 MG20 ML ( 20 MGML )
BLASTN
125472 1
Product
1
Approval Date
10212013
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
162 MG09 ML ( 179 MGML )
Trade Name
Proper Name
BLASTN
103172 0
ACTIVASE
ALTEPLASE
Approval Date Product
11131987 2
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
50 MG ( 50 MGVIAL )
103172 0 3 11131987
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
BLASTN
125085 0
AVASTIN
BEVACIZUMAB
Approval Date Product
2262004 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG4 ML ( 25 MGML )
125085 0 2 2262004
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
400 MG16 ML ( 25 MGML )
March 2018 Page 18 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name CATHFLO ACTIVASE
Proper Name ALTEPLASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103172 0 1 11131987
POWDER INTRACATHETER SINGLE-DOSE VIAL
2 MG ( 2 MGVIAL )
Trade Name
Proper Name
BLASTN
125486 0
GAZYVA
OBINUYUZUMAB
Approval Date Product
1112013 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1000 MG40 ML ( 25 MGML )
Trade Name
Proper Name
BLASTN
761083 0
HEMLIBRA
EMICIZUMAB-KXWH
Approval Date Product
11162017 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML )
761083 0 2 11162017
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
60 MG04 ML ( 150 MGML )
761083 0 3 11162017
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
105 MG07 ML ( 150 MGML )
761083 0 4 11162017
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
150 MGML ( 150 MGML )
Trade Name
Proper Name
BLASTN
103792 0
HERCEPTIN
TRASTUZUMAB
Approval Date Product
9251998 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS MULTI-DOSE VIAL
420 MG ( 420 MGVIAL )
March 2018 Page 19 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
103792 5336 2 2102017 150 MG ( 150 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name KADCYLA
Proper Name ADO-TRASIUZUMAB EMTANSINE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125427 0 1 2222013
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
125427 0 2 2222013
POWDER INTRAVENOUS SINGLE-DOSE VIAL
160 MG ( 160 MGVIAL )
Trade Name
Proper Name
LUCENTIS
RANIBIZUMAB
BLASTN
125156 0
Product
1
Approval Date
6302006
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE
05 MG005 ML ( 10 MGML )
Proper Name RANIDIZUMAB
BLASTN
125156 076
Product
2
Approval Date
8102012
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE
03 MG005 ML ( 6 MGML )
Trade Name
Proper Name
OCREVUS
OCRELIZUMAB
BLASTN
761053 0
Product
1
Approval Date
3282017
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
300 MG10 ML ( 30 MGML )
Trade Name
Proper Name
PERJETA
PERTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 20 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
125409 0 1 682012 420 MG14 ML ( 30 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name PULMOZYME
Proper Name DORNASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103532 0 1 12301993 25 MG25 ML ( 1 MGML )
SOLUTION INHALATION AMPULE
Trade Name RITUXAN
Proper Name RITUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103705 0 1 11261997 100 MG10 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
103705 0 2 11261997 500 MG50 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name RITUXAN HYCELA
Proper Name RITUXIMAB AND HYALURONIDASE HUMAN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761064 0 1 6222017 1400 MG AND 23400 U117 ML ( 11966 MG AND 2000 UML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
761064 0 2 6222017 1600 MG AND 26800 U134 ML ( 11966 MG AND 2000 UML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name TECENTRIQ
Proper Name ATEZOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761034 0 1 582016 1200 MG20 ML ( 60 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name TNKASE
March 2018 Page 21 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Proper Name TENECTEPLASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103909 0 1 622000 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103976 0 1 6202003 150 MG ( 150 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103948 0 1 572001
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML )
Trade Name
Proper Name
FABRAZYME
AGALSIDASE BETA
BLASTN
103979 0
Product
1
Approval Date
4242003
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
5 MG ( 5 MGVIAL )
103979 0 2 4242003
POWDER INTRAVENOUS SINGLE-DOSE VIAL
35 MG ( 35 MGVIAL )
Trade Name
Proper Name
LEMTRADA
ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 22 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENZYME CORP 1596
103948 5139 2 11142014 12 MG12 ML ( 10MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name LUMIZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125291 0 1 5242010 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name NUCALA
Proper Name MEPOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125526 0 1 11142015
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
TANZEUM
ALBIGLUTIDE
BLASTN
125431 0
Product
1
Approval Date
4152014
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS AUTOINJECTOR
30 MG ( 30 MGAUTOINJECTOR )
125431 0 2 4152014
POWDER SUBCUTANEOUS AUTOINJECTOR
50 MG ( 50 MGAUTOINJECTOR )
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name PEGASYS
Proper Name PEGINTERFERON ALFA 2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103964 5204 4 9292011 180 MCG05 ML ( 360 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 23 of 42
CDER Billable Biologic Product List
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Proper Name PEG-INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103964 0 1 10162002 180 MCGML ( 180 MCGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
103964 0 2 10162002 180 MCG05 ML ( 360 MCGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
103964 5204 3 9292011 135 MCG05 ML ( 270 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
ApplicantLicense No HORIZON PHARMA IRELAND LTD 2022
Trade Name ACTIMMUNE
Proper Name INTERFERON GAMMA-1B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103836 0 1 2251999 100 MCG05 ML ( 200 MCGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No HORIZON PHARMA RHEUMATOLOGY LLC 1998
Trade Name KRYSTEXXA
Proper Name PEGLOTICASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125293 0 1 9142010 8MGML ( 8MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 24 of 42
CDER Billable Biologic Product List
ApplicantLicense No HUMAN GENOME SCIENCES INC 1820
Trade Name BENLYSTA
Proper Name BELIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125370 0 1 392011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
120 MG ( 120 MGVIAL )
125370 0 2 392011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
400 MG ( 400 MGVIAL )
125370 0 3 392011
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )
125370 0 4 392011
SOLUTION SUBCUTANEOUS AUTOINJECTOR
200 MGML ( 200 MGML )
BLASTN
761043 0
Product
1
Approval Date
7202017
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )
Trade Name
Proper Name
RAXIBACUMAB
RAXIBACUMAB
BLASTN
125349 0
Product
1
Approval Date
12142012
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1700 MG34 ML ( 50 MGML )
ApplicantLicense No IMCLONE LLC 1695
Trade Name ERBITUX
Proper Name CETUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125084 0 1 2122004 100 MG50 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 25 of 42
CDER Billable Biologic Product List
ApplicantLicense No IMCLONE LLC 1695
125084 0 2 2122004 200 MG100 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No IMMUNEX CORP 1132
Trade Name ENBREL
Proper Name ETANERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103795 0 1 1121998
POWDER SUBCUTANEOUS MULTI-DOSE VIAL
25 MG ( 25 MGVIAL )
103795 5184 2 9272004
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
50 MGML ( 50 MGML )
103795 0 3 9272004
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MGML ( 50 MGML )
103795 5184 4 9272004
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
25 MG05 ML ( 50 MGML )
103795 5556 5 9142017
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MGML ( 50 MGML )
ApplicantLicense No IPSEN BIOPHARM LIMITED 1787
Trade Name DYSPORT
Proper Name ABOBOTULINUMTOXINA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125274 0 1 4292009
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
300 UNITS ( 300 UNITSVIAL )
125274 0 2 4292009
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
500 UNITS ( 500 UNITSVIAL )
March 2018 Page 26 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
Trade Name DARZALEX
Proper Name DARATUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761036 0 1 11162015
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG5 ML ( 20 MGML )
761036 0 2 11162015
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
400 MG20 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
103772 0
REMICADE
INFLIXIMAB
Approval Date Product
8241998 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
BLASTN
103575 0
REOPRO
ABCIXIMAB
Approval Date Product
12221994 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
10 MG5 ML ( 2 MGML )
Trade Name
Proper Name
BLASTN
125289 0
SIMPONI
GOLIMUMAB
Approval Date Product
4242009 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
50 MG05 ML ( 100 MGML )
125289 0 2 4242009
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MG05 ML ( 100 MGML )
125289 0 3 4242009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
100 MGML ( 100 MGML )
March 2018 Page 27 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
125289 0 4 4242009 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name SIMPONI ARIA
Proper Name GOLIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125433 0 1 7182013 50 MG4 ML ( 125 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name STELARA
Proper Name USTEKINUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125261 0 1 9252009 90 MGML ( 90 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125261 0 2 9252009 45 MG05 ML ( 90 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL amp PREFILLED SYRINGE
125261 0 3 9252009 130 MG26 ML ( 5 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761044 0 1 9232016 130 MG26 ML ( 5 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SYLVANT
Proper Name SILTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125496 0 1 4232014 100 MG ( 100 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125496 0 2 4232014 400 MG ( 400 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 28 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
Trade Name TREMFYA
Proper Name GUSELKUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761061 0 1 7132017 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No JAZZ PHARMACEUTICALS INC 1901
Trade Name ERWINAZE
Proper Name ASPARAGINASE ERWINIA CHRYSANTHEMI
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
105359 0 1 11182011 10000 IU ( 10000 IUVIAL )
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103770 0 1 6191998
SOLUTION INTRAMUSCULAR
50 MG05 ML ( 100 MGML )
SINGLE-DOSE VIAL
103770 0 2 6191998
SOLUTION INTRAMUSCULAR
100 MGML ( 100 MGML )
SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name ILUMYA
Proper Name TILDRAKIZUMAB-ASMN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761067 0 1 3202018 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name INTRON A
March 2018 Page 29 of 42
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103132 0 1 641986 10 MIU ( 10 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL INTRAVENOUS SINGLE-DOSE VIAL
103132 0 2 641986 18 MIU ( 18 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL
103132 0 3 641986 50 MIU ( 50 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL
103132 0 4 641986 228 MIU38 ML ( 6 MIUML )
SOLUTION INTRAMUSCULAR SUBCUTANEOUS MULTI-DOSE VIAL
103132 0 5 641986 32 MIU32 ML ( 10 MIUML )
SOLUTION INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL MULTI-DOSE VIAL
Trade Name KEYTRUDA
Proper Name PEMBROLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125514 0 1 942014 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125514 1 2 1152015 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 0 1 1192001 74 MCG ( 74 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SYLATRON
Proper Name PEGINTERFERON ALFA-2B
March 2018 Page 30 of 42
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 5153 2 3292011 296 MCG ( 296 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 3 3292011 444 MCG ( 444 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 4 3292011 888 MCG ( 888 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name ZINPLAVA
Proper Name BEZLOTOXUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761046 0 1 10212016 1000 MG40 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No MERZ PHARMACEUTICALS GMBH 1830
Trade Name XEOMIN
Proper Name INCOBOTULINUMTOXINA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125360 0 1 7302010
POWDER INTRAMUSCULAR
50 U ( 50 UVIAL )
SINGLE-DOSE VIAL
125360 0 2 7302010
POWDER INTRAMUSCULAR
100 U ( 100 UVIAL )
SINGLE-DOSE VIAL
125360 3 3 11202015
POWDER INTRAMUSCULAR
200 U ( 200 UVIAL )
SINGLE-DOSE VIAL
March 2018 Page 31 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
Trade Name ARZERRA
Proper Name OFATUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125326 0 1 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG5 ML ( 20 MGML )
125326 0 2 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1000 MG50 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
125504 0
COSENTYX
SECUKINUMAB
Approval Date Product
1212015 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
150 MG ( 150 MGVIAL )
125504 0 2 1212015
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MGML ( 150 MGML )
125504 0 3 1212015
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MGML ( 150 MGML )
Trade Name
Proper Name
BLASTN
125290 0
EXTAVIA
INTERFERON BETA-1B
Approval Date Product
8142009 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
03 MG ( 03 MGVIAL )
Trade Name
Proper Name
BLASTN
125319 0
ILARIS
CANAKINUMAB
Approval Date Product
6172009 1
PotencyDosage FormRoutePresentation
180 MGVIAL ( 180 MGVIAL )
March 2018 Page 32 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
125319 88 2 12222016 150 MG ( 150 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
125319 0 3 12222016 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SIMULECT
Proper Name BASILIXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103764 0 1 5121998 10 MG ( 10 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
103764 0 2 5121998 20 MG ( 20 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No NPS PHARMACEUTICALS INC 1908
Trade Name NATPARA
Proper Name PARATHYROID HORMONE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 33 of 42
CDER Billable Biologic Product List
ApplicantLicense No PROMETHEUS LABORATORIES INC 1848
Trade Name PROLEUKIN
Proper Name ALDESLEUKIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103293 0 1 551992 22 MIU ( 22 MIUVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760
Trade Name ARCALYST
Proper Name RILONACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125249 0 1 2272008
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
220MG ( 220MGVIAL )
Trade Name
Proper Name
DUPIXENT
DUPILUMAB
BLASTN
761055 0
Product
1
Approval Date
3282017
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
300 MG2 ML ( 150 MGML )
Trade Name
Proper Name
EYLEA
AFLIBERCEPT
BLASTN
125387 0
Product
1
Approval Date
11182011
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
2 MG005 ML ( 40 MGML )
March 2018 Page 34 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Trade Name ELITEK
Proper Name RASBURICASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103946 0 1 7122002
POWDER INTRAVENOUS SINGLE-DOSE VIAL
15 MG ( 15 MGVIAL )
103946 5020 2 162006
POWDER INTRAVENOUS SINGLE-DOSE VIAL
75 MG ( 75 MGVIAL )
Trade Name
Proper Name
BLASTN
761037 0
KEVZARA
SARILUMAB
Approval Date Product
5222017 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MG114 ML ( 13158 MGML )
761037 0 2 5222017
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MG114 ML ( 17544 MGML )
761037 1 3 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MG114 ML ( 13158 MGML )
761037 1 4 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
200 MG114 ML ( 17544 MGML )
Trade Name
Proper Name
BLASTN
103362 0
LEUKINE
SARGRAMOSTIM
Approval Date Product
351991 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
250 MCG ( 250 MCGVIAL )
103362 0 2 351991
SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL
500 MCGML ( 500 MCGML )
Trade Name PRALUENT
March 2018 Page 35 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Proper Name ALIROCUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125559 0 1 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 2 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 3 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125559 0 4 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name ZALTRAP
Proper Name ZIV-AFLIBERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125418 0 1 832012 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125418 0 2 832012 200 MG8 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SEATTLE GENETICS INC 1853
Trade Name ADCETRIS
Proper Name BRENTUXIMAB VEDOTIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125388 1 1 8192011 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 36 of 42
CDER Billable Biologic Product List
ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593
Trade Name ELAPRASE
Proper Name IDURSULFASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125151 0 1 7242006 6 MG3 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SICOR BIOTECH UAB 1803
Trade Name GRANIX
Proper Name TBO-FILGRASTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125294 0 1 8292012
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
300 MCG0 5 ML ( 600 MCGML )
125294 0 2 8292012
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
480 MCG08 ML ( 600 MCGML )
ApplicantLicense No SMITH AND NEPHEW INC 2004
Trade Name REGRANEX
Proper Name BECAPLERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103691 0 1 12161997
GEL TOPICAL
100 UG ( 100 UGGM )
Trade Name
Proper Name
SANTYL
COLLAGENASE
BLASTN
101995 0
Product
1
Approval Date
641965
PotencyDosage FormRoutePresentation
OINTMENT TOPICAL
30 G amp 90 G TUBE ( 250 UGRAM )
March 2018 Page 37 of 42
CDER Billable Biologic Product List
ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718
Trade Name MYOBLOC
Proper Name RIMABOTULINUM TOXIN B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103846 0 1 1282002
SOLUTION INTRAMUSCULAR
2500 IU05 ML ( 5000 IUML )
SINGLE-DOSE VIAL
103846 0 3 1282002
SOLUTION INTRAMUSCULAR
10000 IU2 ML ( 5000 IUML )
SINGLE-DOSE VIAL
Proper Name RIMABOTULINUMTOXINB
BLASTN
103846 0
Product
2
Approval Date
1282002
PotencyDosage FormRoutePresentation
SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL
5000 IUML ( 5000 IUML )
ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832
Trade Name ZEVALIN
Proper Name IBRITUMOMAB TIUXETAN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125019 0 1 2192002 32 MG2 ML ( 16 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
Trade Name KEPIVANCE
Proper Name PALIFERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125103 0 1 12152004 625 MG ( 625 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name KINERET
Proper Name ANAKINRA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 38 of 42
CDER Billable Biologic Product List
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898
Trade Name ENTYVIO
Proper Name VEDOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125476 0 1 5202014 300 MG ( 300 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No TEVA RESPIRATORY LLC 2047
Trade Name CINQAIR
Proper Name RESLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761033 0 1 3232016 100 MG10 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No THERATECHNOLOGIES INC 2091
Trade Name TROGARZO
Proper Name IBALIZUMAB-UIYK
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761065 0 1 362018 200 MG133 ML ( 150 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 39 of 42
CDER Billable Biologic Product List
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
0375 MG03 ML ( 125 MGML )2222017 125422 038 1
ApplicantLicense No UCB INC 1736
Trade Name CIMZIA
Proper Name CERTOLIZUMAB PEGOL
BLASTN Approval Date PotencyDosage FormRoutePresentation Product
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
200 MG ( 200 MGVIAL ) 4222008 125160 0 1
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )5132009 125160 080 2
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
Trade Name CRYSVITA
Proper Name BUROSUMAB-TWZA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761068 0 1 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
10 MGML ( 10 MGML )
761068 0 2 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
20 MGML ( 20 MGML )
761068 0
Trade Name
Proper Name
BLASTN
March 2018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML ) 4172018 3
MEPSEVII
VESTRONIDASE ALFA-VJBK
Approval Date PotencyDosage FormRoutePresentation Product
Page 40 of 42
CDER Billable Biologic Product List
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
761047 0 1 11152017 10 MG5 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No UNITED THERAPEUTICS CORP 1993
Trade Name UNITUXIN
Proper Name DINUTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125516 0 1 3102015 175 MG5 ML ( 35 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053
Trade Name SILIQ
Proper Name BRODALUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761032 0 1 2152017 210 MG15 ML ( 140 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 41 of 42
CDER Billable Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No WYETH PHARMACEUTICALS INC 0003
Trade Name BESPONSA
Proper Name INOTUZUMAB OZOGAMICIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761040 0 1 8172017 09 MG ( 09 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 42 of 42
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 1 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
9172001 103951 0 26
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
200 MCGML ( 200 MCGML ) 09272012
103951 0 27 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
200 MCG04 ML ( 500 MCGML ) 09272012
103951 0 28 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
300 MCGML ( 300 MCGML ) 09272012
103951 0 29 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
300 MCG06 ML ( 500 MCGML ) 09272012
103951 0 30 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
500 MCGML ( 500 MCGML ) 09272012
ApplicantLicense No ASTELLAS PHARMACEUTICALS US INC 1748
Trade Name AMEVIVE
Proper Name ALEFACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125036 0 1 1302003 75 MGVIAL ( 75 MGVIAL ) 09242008
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
125036 0 2 1302003 15 MGVIAL ( 15 MGVIAL ) 09282012
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No BOEHRINGER INGELHEIM PHARMA KG 1251
Trade Name VERLUMA
Proper Name NOFETUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103769 0 1 10131998 10 MGML ( 10 MGML ) 08132013
INTRAVENOUS
March 2018 Page 2 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No CENTOCOR ORTHO BIOTECH PRODUCTS LP 1824
Trade Name ORTHOCLONE OKT3
Proper Name MUROMONAB-CD3
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103463 0 1 9141992 1 MGML ( 1 MGML ) 01112012
SOLUTION INTRAVENOUS AMPULE
ApplicantLicense No EISAI INCORPORATED 1862
Trade Name ONTAK
Proper Name DENILEUKIN DIFTITOX
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103767 0 1 251999 300 MCG2 ML ( 150 MCGML ) 01302014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No ELI LILLY AND CO 1611
Trade Name XIGRIS
Proper Name DROTRECOGIN ALFA (ACTIVATED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125029 0 1 11212001 5 MGVIAL ( 5 MGVIAL ) 10262011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125029 0 2 11212001 20 MGVIAL ( 20 MGVIAL ) 10102011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GENENTECH INC 1048
Trade Name RAPTIVA
Proper Name EFALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125075 0 1 10272003 125 MGVIAL ( 125 MGVIAL ) 09012009
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
March 2018 Page 3 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103976 0 2 6202003 125 MGVIAL ( 125 MGVIAL ) 08252016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103948 0 3 572001 10 MGVIAL ( 10 MGVIAL ) 07062011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name MYOZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125141 0 1 4282006 50 MGVIAL ( 50 MGVIAL ) 10172014
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name BEXXAR THERAPEUTIC REGIME
Proper Name TOSITUMOMAB AND IODINE I-131 TOSITUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125011 0 1 6272003 01 MGML I-131 TOSITUMOMAB ( 01 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 2 6272003 11 MGML I-131 TOSITUMOMAB ( 11 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 3 6272003 14 MGML TOSITUMOMAB ( 14 MGML 03102014 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 4 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No HEMISPHERX BIOPHARMA INC 1703
Trade Name ALFERON N INJECTION
Proper Name INTERFERON ALFA-N3 (HUMAN LEUKOCYTE DERIVED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103158 0 1 10101989 5 MIUVIAL ( 5 MIUVIAL ) 06272013
SOLUTION INTRALESIONAL MULTI-DOSE VIAL
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name ROFERON A
Proper Name INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103145 0 1 641986 3 MIU05 ML ( 3 MIU05 ML ) 06012009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name ZENAPAX
Proper Name DACLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103749 0 1 12101997 25 MG5 ML ( 25 MG5 ML ) 07072011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No KADMON PHARMACEUTICALS LLC 1867
Trade Name INFERGEN
Proper Name INTERFERON ALFACON-1
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103663 0 1 1061997 9 MCG03 ML ( 30 MCGML ) 07252013
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 5 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103770 0 3 6191998 50 MGVIAL ( 50 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
103770 0 4 6191998 100 MGVIAL ( 100 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name INTRON A
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103132 0 6 641986 10 MIUML ( 10 MIUML ) 09232013
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103132 0 7 641986 225 MIU15 ML ( 225 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 8 641986 375 MIU15 ML ( 375 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 9 641986 75 MIU15 ML ( 75 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103949 0 5 1192001 675 MCGPEN ( 675 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 6 1192001 108 MCGPEN ( 108 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
March 2018 Page 6 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name PEGINTRON
103949 0 7 1192001 1184 MCGVIAL ( 1184 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 8 1192001 162 MCGPEN ( 162 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 9 1192001 1776 MCGVIAL ( 1776 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 10 1192001 2025 MCGPEN ( 2025 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 11 1192001 222 MCGVIAL ( 222 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No PALATIN TECHNOLOGIES INC 1588
Trade Name NEUTROSPEC TECHNETIUM (99M TC)
Proper Name FANOLESOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103928 0 1 722004 025 MGVIAL ( 025 MGVIAL ) 09222008
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No RECORDATI RARE DISEASES INC 1899
Trade Name ELSPAR
Proper Name ASPARAGINASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
101063 0 1 1101978 10000 IU ( 10000 IUVIAL ) 04092014
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
March 2018 Page 7 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No SCHERING CORP 0994
Trade Name PEGINTRONREBETOL COMBO PACK
Proper Name PEGINTERFERON ALFA-2B AND RIBAVIRIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125196 0 1 6132008 ( 4 (120 MCG05ML) REDIPEN amp 140 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 2 6132008 ( 4 (150 MCG05ML) REDIPEN amp 168 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 3 6132008 ( 4 (150 MCG05ML) REDIPEN amp 196 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 4 6132008 ( 4 (50 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 5 6132008 ( 4 (80 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125422 0 2 10172012 05 MG ( 25 MGML ) 08082017
SOLUTION INTRAVETREAL SINGLE-DOSE VIAL
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125164 0 10 11142007 50 MCGML ( 50 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 8 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
125164 0 11 11142007 100 MCGML ( 100 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 12 11142007 200 MCGML ( 200 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 13 11142007 300 MCGML ( 300 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 14 11142007 400 MCGML ( 400 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 15 11142007 400 MCG06 ML ( 400 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 16 11142007 600 MCGML ( 600 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 17 11142007 600 MCG06 ML ( 600 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 18 11142007 800 MCG06 ML ( 800 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 19 11142007 1000 MCGML ( 1000 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 9 of 9
CDER Billable Biologic Product List
ApplicantLicense No BAXALTA US INC 2020
Trade Name ONCASPAR
Proper Name PEGASPARGASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103411 0 1 211994 3750 IU5 ML ( 750 IUML )
SOLUTION INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No BAYER HEALTHCARE PHARMACEUTICALS INC 1778
Trade Name BETASERON
Proper Name INTERFERON BETA-1B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103471 0 1 7231993 03 MG ( 03 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No BIOGEN INC 1697
Trade Name AVONEX
Proper Name INTERFERON BETA 1A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103628 0 1 5171996
POWDER INTRAMUSCULAR
30 MCG ( 30 MCGVIAL )
SINGLE-DOSE VIAL
103628 0 2 5171996
SOLUTION INTRAMUSCULAR PREFILLED SYRINGE
30 MCG05 ML ( 30 MCG05 ML )
103628 0 3 5171996
SOLUTION INTRAMUSCULAR AUTOINJECTOR
30 MCG05 ML ( 30 MCG05 ML )
Trade Name
Proper Name
BLASTN
125499 0
PLEGRIDY
PEGINTERFERON BETA-1A
Approval Date PotencyDosage FormRoutePresentation Product
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
63 MCG05 ML ( 126 MCGML ) 8152014 1
March 2018 Page 10 of 42
CDER Billable Biologic Product List
ApplicantLicense No BIOGEN INC 1697
125499 0 2 8152014 125 MCG05 ML ( 250 MCGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125499 0 3 8152014 63 MCG05 ML ( 126 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125499 0 4 8152014 94 MCG05 ML ( 188 MCGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125499 0 5 8152014 94 MCG05 ML ( 188 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125499 0 6 8152014 125 MCG05 ML ( 250 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name TYSABRI
Proper Name NATALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125104 0 1 11232004 300 MG15 ML ( 20 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name ZINBRYTA
Proper Name DACLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761029 0 1 5272016 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
761029 0 2 5272016 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 11 of 42
CDER Billable Biologic Product List
ApplicantLicense No BIOMARIN PHARMACEUTICAL INC 1649
Trade Name ALDURAZYME
Proper Name LARONIDASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125058 0 1 4302003
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
29 MG5 ML ( 058 MGML )
Trade Name
Proper Name
BRINEURA
CERLIPONASE ALFA
BLASTN
761052 0
Product
1
Approval Date
4272017
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENTRICULAR SINGLE-DOSE VIAL
150 MG5 ML ( 30 MGML )
Trade Name
Proper Name
NAGLAZYME
GALSULFASE
BLASTN
125117 0
Product
1
Approval Date
5312005
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
5 MG 5ML ( 1 MGML )
Trade Name
Proper Name
VIMIZIM
ELOSULFASE ALFA
BLASTN
125460 0
Product
1
Approval Date
2142014
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
5 MG5 ML ( 1 MGML )
ApplicantLicense No BOEHRINGER INGELHEIM PHARMACEUTICALS INC 2006
Trade Name PRAXBIND
Proper Name IDARUCIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761025 0 1 10162015 2500 MG50 ML ( 50 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 12 of 42
CDER Billable Biologic Product List
ApplicantLicense No BRISTOL MYERS SQUIBB CO 1713
Trade Name EMPLICITI
Proper Name ELOTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761035 0 1 11302015
POWDER INTRAVENOUS SINGLE-DOSE VIAL
300 MG ( 300 MGVIAL )
761035 0 2 11302015
POWDER INTRAVENOUS SINGLE-DOSE VIAL
400 MG ( 400 MGVIAL )
Trade Name
Proper Name
BLASTN
125288 0
NULOJIX
BELATACEPT
Approval Date Product
6152011 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
250 MG ( 250 MGVIAL )
Trade Name
Proper Name
BLASTN
125554 0
OPDIVO
NIVOLUMAB
Approval Date Product
12222014 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
40 MG4 ML ( 10 MGML )
125554 0 2 12222014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG10 ML ( 10 MGML )
125554 0 3 12222014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
240 MG24 ML ( 10 MGML )
Trade Name
Proper Name
BLASTN
125118 0
ORENCIA
ABATACEPT
Approval Date Product
12232005 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
250 MG ( 250 MGVIAL )
March 2018 Page 13 of 42
CDER Billable Biologic Product List
ApplicantLicense No BRISTOL MYERS SQUIBB CO 1713
125118 122 2 7292011 50 MG04 ML ( 125 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125118 122 3 7292011 875 MG07 ML ( 125 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125118 122 4 7292011 125 MGML ( 125 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125118 122 5 7292011 125 MGML ( 125 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name YERVOY
Proper Name IPILIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125377 0 1 3252011 50 MG10 ML ( 5 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125377 0 2 3252011 200 MG40 ML ( 5 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No BTG INTERNATIONAL INC 1861
Trade Name VORAXAZE
Proper Name GLUCARPIDASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125327 0 1 1172012 1000 U ( 1000 UVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 14 of 42
CDER Billable Biologic Product List
ApplicantLicense No DYAX CORPORATION 1789
Trade Name KALBITOR
Proper Name ECALLANTIDE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125277 0 1 1212009 10 MGML ( 10 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No EKR THERAPEUTICS INC 1814
Trade Name RETAVASE
Proper Name RETEPLASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103786 0 1 561998 10 U ( 10 UVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No ELI LILLY AND CO 1891
Trade Name CYRAMZA
Proper Name RAMUCIRUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125477 0 1 4212014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG10 ML ( 10 MGML )
125477 0 2 4212014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
500 MG50 ML ( 10 MGML )
Trade Name
Proper Name
BLASTN
761038 0
LARTRUVO
OLARATUMAB
Approval Date Product
10192016 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
500 MG50 ML ( 10 MGML )
761038 0 2 10192016
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
190 MG19 ML ( 10 MGML )
March 2018 Page 15 of 42
CDER Billable Biologic Product List
ApplicantLicense No ELI LILLY AND CO 1891
Trade Name PORTRAZZA
Proper Name NECITUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125547 0 1 11242015
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
800 MG50 ML ( 16 MGML )
Trade Name
Proper Name
TALTZ
IXEKIZUMAB
BLASTN
125521 0
Product
1
Approval Date
3222016
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
80 MGML ( 80 MGML )
125521 0 2 3222016
SOLUTION SUBCUTANEOUS AUTOINJECTOR
80 MGML ( 80 MGML )
Trade Name
Proper Name
TRULICITY
DULAGLUTIDE
BLASTN
125469 0
Product
1
Approval Date
9182014
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
075 MG05 ML ( 075 MG05 ML )
125469 0 2 9182014
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
15 MG05 ML ( 15 MG05 ML )
125469 0 3 9182014
SOLUTION SUBCUTANEOUS AUTOINJECTOR
075 MG05 ML ( 075 MG05 ML )
125469 0 4 9182014
SOLUTION SUBCUTANEOUS AUTOINJECTOR
15 MG05 ML ( 15 MG05 ML )
March 2018 Page 16 of 42
CDER Billable Biologic Product List
ApplicantLicense No ELUSYS THERAPEUTICS INC 1907
Trade Name ANTHIM
Proper Name OBILTOXAXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125509 1 1 3182016 600 MG6 ML ( 100 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No EMD SERONO INC 1773
Trade Name BAVENCIO
Proper Name AVELUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761049 0 1 3232017
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
200 MG10 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
103780 0
REBIF
INTERFERON BETA 1A
Approval Date Product
372002 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
88 MCG02 ML ( 44 MCGML )
103780 0 2 372002
SOLUTION SUBCUTANEOUS AUTOINJECTOR
88 MCG02 ML ( 44 MCGML )
103780 0 3 372002
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
22 MCG05 ML ( 44 MCGML )
103780 0 4 372002
SOLUTION SUBCUTANEOUS AUTOINJECTOR
22 MCG05 ML ( 44 MCGML )
103780 0 5 372002
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
44 MCG05 ML ( 88 MCGML )
103780 0 6 372002
SOLUTION SUBCUTANEOUS AUTOINJECTOR
44 MCG05 ML ( 88 MCGML )
March 2018 Page 17 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name ACTEMRA
Proper Name TOCILIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125276 0 1 182010
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
80 MG4 ML ( 20 MGML )
125276 0 2 182010
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
200 MG10 ML ( 20 MGML )
125276 0 3 182010
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
400 MG20 ML ( 20 MGML )
BLASTN
125472 1
Product
1
Approval Date
10212013
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
162 MG09 ML ( 179 MGML )
Trade Name
Proper Name
BLASTN
103172 0
ACTIVASE
ALTEPLASE
Approval Date Product
11131987 2
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
50 MG ( 50 MGVIAL )
103172 0 3 11131987
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
BLASTN
125085 0
AVASTIN
BEVACIZUMAB
Approval Date Product
2262004 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG4 ML ( 25 MGML )
125085 0 2 2262004
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
400 MG16 ML ( 25 MGML )
March 2018 Page 18 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name CATHFLO ACTIVASE
Proper Name ALTEPLASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103172 0 1 11131987
POWDER INTRACATHETER SINGLE-DOSE VIAL
2 MG ( 2 MGVIAL )
Trade Name
Proper Name
BLASTN
125486 0
GAZYVA
OBINUYUZUMAB
Approval Date Product
1112013 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1000 MG40 ML ( 25 MGML )
Trade Name
Proper Name
BLASTN
761083 0
HEMLIBRA
EMICIZUMAB-KXWH
Approval Date Product
11162017 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML )
761083 0 2 11162017
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
60 MG04 ML ( 150 MGML )
761083 0 3 11162017
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
105 MG07 ML ( 150 MGML )
761083 0 4 11162017
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
150 MGML ( 150 MGML )
Trade Name
Proper Name
BLASTN
103792 0
HERCEPTIN
TRASTUZUMAB
Approval Date Product
9251998 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS MULTI-DOSE VIAL
420 MG ( 420 MGVIAL )
March 2018 Page 19 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
103792 5336 2 2102017 150 MG ( 150 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name KADCYLA
Proper Name ADO-TRASIUZUMAB EMTANSINE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125427 0 1 2222013
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
125427 0 2 2222013
POWDER INTRAVENOUS SINGLE-DOSE VIAL
160 MG ( 160 MGVIAL )
Trade Name
Proper Name
LUCENTIS
RANIBIZUMAB
BLASTN
125156 0
Product
1
Approval Date
6302006
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE
05 MG005 ML ( 10 MGML )
Proper Name RANIDIZUMAB
BLASTN
125156 076
Product
2
Approval Date
8102012
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE
03 MG005 ML ( 6 MGML )
Trade Name
Proper Name
OCREVUS
OCRELIZUMAB
BLASTN
761053 0
Product
1
Approval Date
3282017
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
300 MG10 ML ( 30 MGML )
Trade Name
Proper Name
PERJETA
PERTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 20 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
125409 0 1 682012 420 MG14 ML ( 30 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name PULMOZYME
Proper Name DORNASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103532 0 1 12301993 25 MG25 ML ( 1 MGML )
SOLUTION INHALATION AMPULE
Trade Name RITUXAN
Proper Name RITUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103705 0 1 11261997 100 MG10 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
103705 0 2 11261997 500 MG50 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name RITUXAN HYCELA
Proper Name RITUXIMAB AND HYALURONIDASE HUMAN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761064 0 1 6222017 1400 MG AND 23400 U117 ML ( 11966 MG AND 2000 UML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
761064 0 2 6222017 1600 MG AND 26800 U134 ML ( 11966 MG AND 2000 UML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name TECENTRIQ
Proper Name ATEZOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761034 0 1 582016 1200 MG20 ML ( 60 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name TNKASE
March 2018 Page 21 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Proper Name TENECTEPLASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103909 0 1 622000 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103976 0 1 6202003 150 MG ( 150 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103948 0 1 572001
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML )
Trade Name
Proper Name
FABRAZYME
AGALSIDASE BETA
BLASTN
103979 0
Product
1
Approval Date
4242003
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
5 MG ( 5 MGVIAL )
103979 0 2 4242003
POWDER INTRAVENOUS SINGLE-DOSE VIAL
35 MG ( 35 MGVIAL )
Trade Name
Proper Name
LEMTRADA
ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 22 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENZYME CORP 1596
103948 5139 2 11142014 12 MG12 ML ( 10MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name LUMIZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125291 0 1 5242010 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name NUCALA
Proper Name MEPOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125526 0 1 11142015
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
TANZEUM
ALBIGLUTIDE
BLASTN
125431 0
Product
1
Approval Date
4152014
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS AUTOINJECTOR
30 MG ( 30 MGAUTOINJECTOR )
125431 0 2 4152014
POWDER SUBCUTANEOUS AUTOINJECTOR
50 MG ( 50 MGAUTOINJECTOR )
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name PEGASYS
Proper Name PEGINTERFERON ALFA 2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103964 5204 4 9292011 180 MCG05 ML ( 360 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 23 of 42
CDER Billable Biologic Product List
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Proper Name PEG-INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103964 0 1 10162002 180 MCGML ( 180 MCGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
103964 0 2 10162002 180 MCG05 ML ( 360 MCGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
103964 5204 3 9292011 135 MCG05 ML ( 270 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
ApplicantLicense No HORIZON PHARMA IRELAND LTD 2022
Trade Name ACTIMMUNE
Proper Name INTERFERON GAMMA-1B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103836 0 1 2251999 100 MCG05 ML ( 200 MCGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No HORIZON PHARMA RHEUMATOLOGY LLC 1998
Trade Name KRYSTEXXA
Proper Name PEGLOTICASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125293 0 1 9142010 8MGML ( 8MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 24 of 42
CDER Billable Biologic Product List
ApplicantLicense No HUMAN GENOME SCIENCES INC 1820
Trade Name BENLYSTA
Proper Name BELIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125370 0 1 392011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
120 MG ( 120 MGVIAL )
125370 0 2 392011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
400 MG ( 400 MGVIAL )
125370 0 3 392011
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )
125370 0 4 392011
SOLUTION SUBCUTANEOUS AUTOINJECTOR
200 MGML ( 200 MGML )
BLASTN
761043 0
Product
1
Approval Date
7202017
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )
Trade Name
Proper Name
RAXIBACUMAB
RAXIBACUMAB
BLASTN
125349 0
Product
1
Approval Date
12142012
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1700 MG34 ML ( 50 MGML )
ApplicantLicense No IMCLONE LLC 1695
Trade Name ERBITUX
Proper Name CETUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125084 0 1 2122004 100 MG50 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 25 of 42
CDER Billable Biologic Product List
ApplicantLicense No IMCLONE LLC 1695
125084 0 2 2122004 200 MG100 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No IMMUNEX CORP 1132
Trade Name ENBREL
Proper Name ETANERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103795 0 1 1121998
POWDER SUBCUTANEOUS MULTI-DOSE VIAL
25 MG ( 25 MGVIAL )
103795 5184 2 9272004
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
50 MGML ( 50 MGML )
103795 0 3 9272004
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MGML ( 50 MGML )
103795 5184 4 9272004
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
25 MG05 ML ( 50 MGML )
103795 5556 5 9142017
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MGML ( 50 MGML )
ApplicantLicense No IPSEN BIOPHARM LIMITED 1787
Trade Name DYSPORT
Proper Name ABOBOTULINUMTOXINA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125274 0 1 4292009
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
300 UNITS ( 300 UNITSVIAL )
125274 0 2 4292009
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
500 UNITS ( 500 UNITSVIAL )
March 2018 Page 26 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
Trade Name DARZALEX
Proper Name DARATUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761036 0 1 11162015
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG5 ML ( 20 MGML )
761036 0 2 11162015
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
400 MG20 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
103772 0
REMICADE
INFLIXIMAB
Approval Date Product
8241998 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
BLASTN
103575 0
REOPRO
ABCIXIMAB
Approval Date Product
12221994 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
10 MG5 ML ( 2 MGML )
Trade Name
Proper Name
BLASTN
125289 0
SIMPONI
GOLIMUMAB
Approval Date Product
4242009 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
50 MG05 ML ( 100 MGML )
125289 0 2 4242009
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MG05 ML ( 100 MGML )
125289 0 3 4242009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
100 MGML ( 100 MGML )
March 2018 Page 27 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
125289 0 4 4242009 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name SIMPONI ARIA
Proper Name GOLIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125433 0 1 7182013 50 MG4 ML ( 125 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name STELARA
Proper Name USTEKINUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125261 0 1 9252009 90 MGML ( 90 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125261 0 2 9252009 45 MG05 ML ( 90 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL amp PREFILLED SYRINGE
125261 0 3 9252009 130 MG26 ML ( 5 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761044 0 1 9232016 130 MG26 ML ( 5 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SYLVANT
Proper Name SILTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125496 0 1 4232014 100 MG ( 100 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125496 0 2 4232014 400 MG ( 400 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 28 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
Trade Name TREMFYA
Proper Name GUSELKUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761061 0 1 7132017 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No JAZZ PHARMACEUTICALS INC 1901
Trade Name ERWINAZE
Proper Name ASPARAGINASE ERWINIA CHRYSANTHEMI
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
105359 0 1 11182011 10000 IU ( 10000 IUVIAL )
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103770 0 1 6191998
SOLUTION INTRAMUSCULAR
50 MG05 ML ( 100 MGML )
SINGLE-DOSE VIAL
103770 0 2 6191998
SOLUTION INTRAMUSCULAR
100 MGML ( 100 MGML )
SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name ILUMYA
Proper Name TILDRAKIZUMAB-ASMN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761067 0 1 3202018 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name INTRON A
March 2018 Page 29 of 42
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103132 0 1 641986 10 MIU ( 10 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL INTRAVENOUS SINGLE-DOSE VIAL
103132 0 2 641986 18 MIU ( 18 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL
103132 0 3 641986 50 MIU ( 50 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL
103132 0 4 641986 228 MIU38 ML ( 6 MIUML )
SOLUTION INTRAMUSCULAR SUBCUTANEOUS MULTI-DOSE VIAL
103132 0 5 641986 32 MIU32 ML ( 10 MIUML )
SOLUTION INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL MULTI-DOSE VIAL
Trade Name KEYTRUDA
Proper Name PEMBROLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125514 0 1 942014 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125514 1 2 1152015 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 0 1 1192001 74 MCG ( 74 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SYLATRON
Proper Name PEGINTERFERON ALFA-2B
March 2018 Page 30 of 42
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 5153 2 3292011 296 MCG ( 296 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 3 3292011 444 MCG ( 444 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 4 3292011 888 MCG ( 888 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name ZINPLAVA
Proper Name BEZLOTOXUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761046 0 1 10212016 1000 MG40 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No MERZ PHARMACEUTICALS GMBH 1830
Trade Name XEOMIN
Proper Name INCOBOTULINUMTOXINA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125360 0 1 7302010
POWDER INTRAMUSCULAR
50 U ( 50 UVIAL )
SINGLE-DOSE VIAL
125360 0 2 7302010
POWDER INTRAMUSCULAR
100 U ( 100 UVIAL )
SINGLE-DOSE VIAL
125360 3 3 11202015
POWDER INTRAMUSCULAR
200 U ( 200 UVIAL )
SINGLE-DOSE VIAL
March 2018 Page 31 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
Trade Name ARZERRA
Proper Name OFATUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125326 0 1 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG5 ML ( 20 MGML )
125326 0 2 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1000 MG50 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
125504 0
COSENTYX
SECUKINUMAB
Approval Date Product
1212015 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
150 MG ( 150 MGVIAL )
125504 0 2 1212015
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MGML ( 150 MGML )
125504 0 3 1212015
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MGML ( 150 MGML )
Trade Name
Proper Name
BLASTN
125290 0
EXTAVIA
INTERFERON BETA-1B
Approval Date Product
8142009 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
03 MG ( 03 MGVIAL )
Trade Name
Proper Name
BLASTN
125319 0
ILARIS
CANAKINUMAB
Approval Date Product
6172009 1
PotencyDosage FormRoutePresentation
180 MGVIAL ( 180 MGVIAL )
March 2018 Page 32 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
125319 88 2 12222016 150 MG ( 150 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
125319 0 3 12222016 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SIMULECT
Proper Name BASILIXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103764 0 1 5121998 10 MG ( 10 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
103764 0 2 5121998 20 MG ( 20 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No NPS PHARMACEUTICALS INC 1908
Trade Name NATPARA
Proper Name PARATHYROID HORMONE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 33 of 42
CDER Billable Biologic Product List
ApplicantLicense No PROMETHEUS LABORATORIES INC 1848
Trade Name PROLEUKIN
Proper Name ALDESLEUKIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103293 0 1 551992 22 MIU ( 22 MIUVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760
Trade Name ARCALYST
Proper Name RILONACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125249 0 1 2272008
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
220MG ( 220MGVIAL )
Trade Name
Proper Name
DUPIXENT
DUPILUMAB
BLASTN
761055 0
Product
1
Approval Date
3282017
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
300 MG2 ML ( 150 MGML )
Trade Name
Proper Name
EYLEA
AFLIBERCEPT
BLASTN
125387 0
Product
1
Approval Date
11182011
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
2 MG005 ML ( 40 MGML )
March 2018 Page 34 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Trade Name ELITEK
Proper Name RASBURICASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103946 0 1 7122002
POWDER INTRAVENOUS SINGLE-DOSE VIAL
15 MG ( 15 MGVIAL )
103946 5020 2 162006
POWDER INTRAVENOUS SINGLE-DOSE VIAL
75 MG ( 75 MGVIAL )
Trade Name
Proper Name
BLASTN
761037 0
KEVZARA
SARILUMAB
Approval Date Product
5222017 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MG114 ML ( 13158 MGML )
761037 0 2 5222017
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MG114 ML ( 17544 MGML )
761037 1 3 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MG114 ML ( 13158 MGML )
761037 1 4 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
200 MG114 ML ( 17544 MGML )
Trade Name
Proper Name
BLASTN
103362 0
LEUKINE
SARGRAMOSTIM
Approval Date Product
351991 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
250 MCG ( 250 MCGVIAL )
103362 0 2 351991
SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL
500 MCGML ( 500 MCGML )
Trade Name PRALUENT
March 2018 Page 35 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Proper Name ALIROCUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125559 0 1 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 2 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 3 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125559 0 4 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name ZALTRAP
Proper Name ZIV-AFLIBERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125418 0 1 832012 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125418 0 2 832012 200 MG8 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SEATTLE GENETICS INC 1853
Trade Name ADCETRIS
Proper Name BRENTUXIMAB VEDOTIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125388 1 1 8192011 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 36 of 42
CDER Billable Biologic Product List
ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593
Trade Name ELAPRASE
Proper Name IDURSULFASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125151 0 1 7242006 6 MG3 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SICOR BIOTECH UAB 1803
Trade Name GRANIX
Proper Name TBO-FILGRASTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125294 0 1 8292012
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
300 MCG0 5 ML ( 600 MCGML )
125294 0 2 8292012
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
480 MCG08 ML ( 600 MCGML )
ApplicantLicense No SMITH AND NEPHEW INC 2004
Trade Name REGRANEX
Proper Name BECAPLERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103691 0 1 12161997
GEL TOPICAL
100 UG ( 100 UGGM )
Trade Name
Proper Name
SANTYL
COLLAGENASE
BLASTN
101995 0
Product
1
Approval Date
641965
PotencyDosage FormRoutePresentation
OINTMENT TOPICAL
30 G amp 90 G TUBE ( 250 UGRAM )
March 2018 Page 37 of 42
CDER Billable Biologic Product List
ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718
Trade Name MYOBLOC
Proper Name RIMABOTULINUM TOXIN B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103846 0 1 1282002
SOLUTION INTRAMUSCULAR
2500 IU05 ML ( 5000 IUML )
SINGLE-DOSE VIAL
103846 0 3 1282002
SOLUTION INTRAMUSCULAR
10000 IU2 ML ( 5000 IUML )
SINGLE-DOSE VIAL
Proper Name RIMABOTULINUMTOXINB
BLASTN
103846 0
Product
2
Approval Date
1282002
PotencyDosage FormRoutePresentation
SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL
5000 IUML ( 5000 IUML )
ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832
Trade Name ZEVALIN
Proper Name IBRITUMOMAB TIUXETAN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125019 0 1 2192002 32 MG2 ML ( 16 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
Trade Name KEPIVANCE
Proper Name PALIFERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125103 0 1 12152004 625 MG ( 625 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name KINERET
Proper Name ANAKINRA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 38 of 42
CDER Billable Biologic Product List
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898
Trade Name ENTYVIO
Proper Name VEDOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125476 0 1 5202014 300 MG ( 300 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No TEVA RESPIRATORY LLC 2047
Trade Name CINQAIR
Proper Name RESLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761033 0 1 3232016 100 MG10 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No THERATECHNOLOGIES INC 2091
Trade Name TROGARZO
Proper Name IBALIZUMAB-UIYK
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761065 0 1 362018 200 MG133 ML ( 150 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 39 of 42
CDER Billable Biologic Product List
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
0375 MG03 ML ( 125 MGML )2222017 125422 038 1
ApplicantLicense No UCB INC 1736
Trade Name CIMZIA
Proper Name CERTOLIZUMAB PEGOL
BLASTN Approval Date PotencyDosage FormRoutePresentation Product
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
200 MG ( 200 MGVIAL ) 4222008 125160 0 1
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )5132009 125160 080 2
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
Trade Name CRYSVITA
Proper Name BUROSUMAB-TWZA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761068 0 1 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
10 MGML ( 10 MGML )
761068 0 2 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
20 MGML ( 20 MGML )
761068 0
Trade Name
Proper Name
BLASTN
March 2018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML ) 4172018 3
MEPSEVII
VESTRONIDASE ALFA-VJBK
Approval Date PotencyDosage FormRoutePresentation Product
Page 40 of 42
CDER Billable Biologic Product List
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
761047 0 1 11152017 10 MG5 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No UNITED THERAPEUTICS CORP 1993
Trade Name UNITUXIN
Proper Name DINUTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125516 0 1 3102015 175 MG5 ML ( 35 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053
Trade Name SILIQ
Proper Name BRODALUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761032 0 1 2152017 210 MG15 ML ( 140 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 41 of 42
CDER Billable Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No WYETH PHARMACEUTICALS INC 0003
Trade Name BESPONSA
Proper Name INOTUZUMAB OZOGAMICIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761040 0 1 8172017 09 MG ( 09 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 42 of 42
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 1 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
9172001 103951 0 26
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
200 MCGML ( 200 MCGML ) 09272012
103951 0 27 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
200 MCG04 ML ( 500 MCGML ) 09272012
103951 0 28 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
300 MCGML ( 300 MCGML ) 09272012
103951 0 29 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
300 MCG06 ML ( 500 MCGML ) 09272012
103951 0 30 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
500 MCGML ( 500 MCGML ) 09272012
ApplicantLicense No ASTELLAS PHARMACEUTICALS US INC 1748
Trade Name AMEVIVE
Proper Name ALEFACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125036 0 1 1302003 75 MGVIAL ( 75 MGVIAL ) 09242008
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
125036 0 2 1302003 15 MGVIAL ( 15 MGVIAL ) 09282012
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No BOEHRINGER INGELHEIM PHARMA KG 1251
Trade Name VERLUMA
Proper Name NOFETUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103769 0 1 10131998 10 MGML ( 10 MGML ) 08132013
INTRAVENOUS
March 2018 Page 2 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No CENTOCOR ORTHO BIOTECH PRODUCTS LP 1824
Trade Name ORTHOCLONE OKT3
Proper Name MUROMONAB-CD3
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103463 0 1 9141992 1 MGML ( 1 MGML ) 01112012
SOLUTION INTRAVENOUS AMPULE
ApplicantLicense No EISAI INCORPORATED 1862
Trade Name ONTAK
Proper Name DENILEUKIN DIFTITOX
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103767 0 1 251999 300 MCG2 ML ( 150 MCGML ) 01302014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No ELI LILLY AND CO 1611
Trade Name XIGRIS
Proper Name DROTRECOGIN ALFA (ACTIVATED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125029 0 1 11212001 5 MGVIAL ( 5 MGVIAL ) 10262011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125029 0 2 11212001 20 MGVIAL ( 20 MGVIAL ) 10102011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GENENTECH INC 1048
Trade Name RAPTIVA
Proper Name EFALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125075 0 1 10272003 125 MGVIAL ( 125 MGVIAL ) 09012009
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
March 2018 Page 3 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103976 0 2 6202003 125 MGVIAL ( 125 MGVIAL ) 08252016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103948 0 3 572001 10 MGVIAL ( 10 MGVIAL ) 07062011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name MYOZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125141 0 1 4282006 50 MGVIAL ( 50 MGVIAL ) 10172014
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name BEXXAR THERAPEUTIC REGIME
Proper Name TOSITUMOMAB AND IODINE I-131 TOSITUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125011 0 1 6272003 01 MGML I-131 TOSITUMOMAB ( 01 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 2 6272003 11 MGML I-131 TOSITUMOMAB ( 11 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 3 6272003 14 MGML TOSITUMOMAB ( 14 MGML 03102014 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 4 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No HEMISPHERX BIOPHARMA INC 1703
Trade Name ALFERON N INJECTION
Proper Name INTERFERON ALFA-N3 (HUMAN LEUKOCYTE DERIVED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103158 0 1 10101989 5 MIUVIAL ( 5 MIUVIAL ) 06272013
SOLUTION INTRALESIONAL MULTI-DOSE VIAL
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name ROFERON A
Proper Name INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103145 0 1 641986 3 MIU05 ML ( 3 MIU05 ML ) 06012009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name ZENAPAX
Proper Name DACLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103749 0 1 12101997 25 MG5 ML ( 25 MG5 ML ) 07072011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No KADMON PHARMACEUTICALS LLC 1867
Trade Name INFERGEN
Proper Name INTERFERON ALFACON-1
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103663 0 1 1061997 9 MCG03 ML ( 30 MCGML ) 07252013
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 5 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103770 0 3 6191998 50 MGVIAL ( 50 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
103770 0 4 6191998 100 MGVIAL ( 100 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name INTRON A
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103132 0 6 641986 10 MIUML ( 10 MIUML ) 09232013
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103132 0 7 641986 225 MIU15 ML ( 225 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 8 641986 375 MIU15 ML ( 375 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 9 641986 75 MIU15 ML ( 75 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103949 0 5 1192001 675 MCGPEN ( 675 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 6 1192001 108 MCGPEN ( 108 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
March 2018 Page 6 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name PEGINTRON
103949 0 7 1192001 1184 MCGVIAL ( 1184 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 8 1192001 162 MCGPEN ( 162 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 9 1192001 1776 MCGVIAL ( 1776 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 10 1192001 2025 MCGPEN ( 2025 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 11 1192001 222 MCGVIAL ( 222 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No PALATIN TECHNOLOGIES INC 1588
Trade Name NEUTROSPEC TECHNETIUM (99M TC)
Proper Name FANOLESOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103928 0 1 722004 025 MGVIAL ( 025 MGVIAL ) 09222008
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No RECORDATI RARE DISEASES INC 1899
Trade Name ELSPAR
Proper Name ASPARAGINASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
101063 0 1 1101978 10000 IU ( 10000 IUVIAL ) 04092014
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
March 2018 Page 7 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No SCHERING CORP 0994
Trade Name PEGINTRONREBETOL COMBO PACK
Proper Name PEGINTERFERON ALFA-2B AND RIBAVIRIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125196 0 1 6132008 ( 4 (120 MCG05ML) REDIPEN amp 140 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 2 6132008 ( 4 (150 MCG05ML) REDIPEN amp 168 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 3 6132008 ( 4 (150 MCG05ML) REDIPEN amp 196 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 4 6132008 ( 4 (50 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 5 6132008 ( 4 (80 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125422 0 2 10172012 05 MG ( 25 MGML ) 08082017
SOLUTION INTRAVETREAL SINGLE-DOSE VIAL
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125164 0 10 11142007 50 MCGML ( 50 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 8 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
125164 0 11 11142007 100 MCGML ( 100 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 12 11142007 200 MCGML ( 200 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 13 11142007 300 MCGML ( 300 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 14 11142007 400 MCGML ( 400 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 15 11142007 400 MCG06 ML ( 400 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 16 11142007 600 MCGML ( 600 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 17 11142007 600 MCG06 ML ( 600 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 18 11142007 800 MCG06 ML ( 800 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 19 11142007 1000 MCGML ( 1000 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 9 of 9
CDER Billable Biologic Product List
ApplicantLicense No BIOGEN INC 1697
125499 0 2 8152014 125 MCG05 ML ( 250 MCGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125499 0 3 8152014 63 MCG05 ML ( 126 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125499 0 4 8152014 94 MCG05 ML ( 188 MCGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125499 0 5 8152014 94 MCG05 ML ( 188 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125499 0 6 8152014 125 MCG05 ML ( 250 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name TYSABRI
Proper Name NATALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125104 0 1 11232004 300 MG15 ML ( 20 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name ZINBRYTA
Proper Name DACLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761029 0 1 5272016 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
761029 0 2 5272016 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 11 of 42
CDER Billable Biologic Product List
ApplicantLicense No BIOMARIN PHARMACEUTICAL INC 1649
Trade Name ALDURAZYME
Proper Name LARONIDASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125058 0 1 4302003
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
29 MG5 ML ( 058 MGML )
Trade Name
Proper Name
BRINEURA
CERLIPONASE ALFA
BLASTN
761052 0
Product
1
Approval Date
4272017
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENTRICULAR SINGLE-DOSE VIAL
150 MG5 ML ( 30 MGML )
Trade Name
Proper Name
NAGLAZYME
GALSULFASE
BLASTN
125117 0
Product
1
Approval Date
5312005
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
5 MG 5ML ( 1 MGML )
Trade Name
Proper Name
VIMIZIM
ELOSULFASE ALFA
BLASTN
125460 0
Product
1
Approval Date
2142014
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
5 MG5 ML ( 1 MGML )
ApplicantLicense No BOEHRINGER INGELHEIM PHARMACEUTICALS INC 2006
Trade Name PRAXBIND
Proper Name IDARUCIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761025 0 1 10162015 2500 MG50 ML ( 50 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 12 of 42
CDER Billable Biologic Product List
ApplicantLicense No BRISTOL MYERS SQUIBB CO 1713
Trade Name EMPLICITI
Proper Name ELOTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761035 0 1 11302015
POWDER INTRAVENOUS SINGLE-DOSE VIAL
300 MG ( 300 MGVIAL )
761035 0 2 11302015
POWDER INTRAVENOUS SINGLE-DOSE VIAL
400 MG ( 400 MGVIAL )
Trade Name
Proper Name
BLASTN
125288 0
NULOJIX
BELATACEPT
Approval Date Product
6152011 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
250 MG ( 250 MGVIAL )
Trade Name
Proper Name
BLASTN
125554 0
OPDIVO
NIVOLUMAB
Approval Date Product
12222014 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
40 MG4 ML ( 10 MGML )
125554 0 2 12222014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG10 ML ( 10 MGML )
125554 0 3 12222014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
240 MG24 ML ( 10 MGML )
Trade Name
Proper Name
BLASTN
125118 0
ORENCIA
ABATACEPT
Approval Date Product
12232005 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
250 MG ( 250 MGVIAL )
March 2018 Page 13 of 42
CDER Billable Biologic Product List
ApplicantLicense No BRISTOL MYERS SQUIBB CO 1713
125118 122 2 7292011 50 MG04 ML ( 125 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125118 122 3 7292011 875 MG07 ML ( 125 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125118 122 4 7292011 125 MGML ( 125 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125118 122 5 7292011 125 MGML ( 125 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name YERVOY
Proper Name IPILIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125377 0 1 3252011 50 MG10 ML ( 5 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125377 0 2 3252011 200 MG40 ML ( 5 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No BTG INTERNATIONAL INC 1861
Trade Name VORAXAZE
Proper Name GLUCARPIDASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125327 0 1 1172012 1000 U ( 1000 UVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 14 of 42
CDER Billable Biologic Product List
ApplicantLicense No DYAX CORPORATION 1789
Trade Name KALBITOR
Proper Name ECALLANTIDE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125277 0 1 1212009 10 MGML ( 10 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No EKR THERAPEUTICS INC 1814
Trade Name RETAVASE
Proper Name RETEPLASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103786 0 1 561998 10 U ( 10 UVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No ELI LILLY AND CO 1891
Trade Name CYRAMZA
Proper Name RAMUCIRUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125477 0 1 4212014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG10 ML ( 10 MGML )
125477 0 2 4212014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
500 MG50 ML ( 10 MGML )
Trade Name
Proper Name
BLASTN
761038 0
LARTRUVO
OLARATUMAB
Approval Date Product
10192016 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
500 MG50 ML ( 10 MGML )
761038 0 2 10192016
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
190 MG19 ML ( 10 MGML )
March 2018 Page 15 of 42
CDER Billable Biologic Product List
ApplicantLicense No ELI LILLY AND CO 1891
Trade Name PORTRAZZA
Proper Name NECITUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125547 0 1 11242015
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
800 MG50 ML ( 16 MGML )
Trade Name
Proper Name
TALTZ
IXEKIZUMAB
BLASTN
125521 0
Product
1
Approval Date
3222016
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
80 MGML ( 80 MGML )
125521 0 2 3222016
SOLUTION SUBCUTANEOUS AUTOINJECTOR
80 MGML ( 80 MGML )
Trade Name
Proper Name
TRULICITY
DULAGLUTIDE
BLASTN
125469 0
Product
1
Approval Date
9182014
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
075 MG05 ML ( 075 MG05 ML )
125469 0 2 9182014
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
15 MG05 ML ( 15 MG05 ML )
125469 0 3 9182014
SOLUTION SUBCUTANEOUS AUTOINJECTOR
075 MG05 ML ( 075 MG05 ML )
125469 0 4 9182014
SOLUTION SUBCUTANEOUS AUTOINJECTOR
15 MG05 ML ( 15 MG05 ML )
March 2018 Page 16 of 42
CDER Billable Biologic Product List
ApplicantLicense No ELUSYS THERAPEUTICS INC 1907
Trade Name ANTHIM
Proper Name OBILTOXAXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125509 1 1 3182016 600 MG6 ML ( 100 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No EMD SERONO INC 1773
Trade Name BAVENCIO
Proper Name AVELUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761049 0 1 3232017
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
200 MG10 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
103780 0
REBIF
INTERFERON BETA 1A
Approval Date Product
372002 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
88 MCG02 ML ( 44 MCGML )
103780 0 2 372002
SOLUTION SUBCUTANEOUS AUTOINJECTOR
88 MCG02 ML ( 44 MCGML )
103780 0 3 372002
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
22 MCG05 ML ( 44 MCGML )
103780 0 4 372002
SOLUTION SUBCUTANEOUS AUTOINJECTOR
22 MCG05 ML ( 44 MCGML )
103780 0 5 372002
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
44 MCG05 ML ( 88 MCGML )
103780 0 6 372002
SOLUTION SUBCUTANEOUS AUTOINJECTOR
44 MCG05 ML ( 88 MCGML )
March 2018 Page 17 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name ACTEMRA
Proper Name TOCILIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125276 0 1 182010
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
80 MG4 ML ( 20 MGML )
125276 0 2 182010
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
200 MG10 ML ( 20 MGML )
125276 0 3 182010
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
400 MG20 ML ( 20 MGML )
BLASTN
125472 1
Product
1
Approval Date
10212013
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
162 MG09 ML ( 179 MGML )
Trade Name
Proper Name
BLASTN
103172 0
ACTIVASE
ALTEPLASE
Approval Date Product
11131987 2
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
50 MG ( 50 MGVIAL )
103172 0 3 11131987
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
BLASTN
125085 0
AVASTIN
BEVACIZUMAB
Approval Date Product
2262004 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG4 ML ( 25 MGML )
125085 0 2 2262004
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
400 MG16 ML ( 25 MGML )
March 2018 Page 18 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name CATHFLO ACTIVASE
Proper Name ALTEPLASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103172 0 1 11131987
POWDER INTRACATHETER SINGLE-DOSE VIAL
2 MG ( 2 MGVIAL )
Trade Name
Proper Name
BLASTN
125486 0
GAZYVA
OBINUYUZUMAB
Approval Date Product
1112013 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1000 MG40 ML ( 25 MGML )
Trade Name
Proper Name
BLASTN
761083 0
HEMLIBRA
EMICIZUMAB-KXWH
Approval Date Product
11162017 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML )
761083 0 2 11162017
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
60 MG04 ML ( 150 MGML )
761083 0 3 11162017
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
105 MG07 ML ( 150 MGML )
761083 0 4 11162017
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
150 MGML ( 150 MGML )
Trade Name
Proper Name
BLASTN
103792 0
HERCEPTIN
TRASTUZUMAB
Approval Date Product
9251998 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS MULTI-DOSE VIAL
420 MG ( 420 MGVIAL )
March 2018 Page 19 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
103792 5336 2 2102017 150 MG ( 150 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name KADCYLA
Proper Name ADO-TRASIUZUMAB EMTANSINE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125427 0 1 2222013
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
125427 0 2 2222013
POWDER INTRAVENOUS SINGLE-DOSE VIAL
160 MG ( 160 MGVIAL )
Trade Name
Proper Name
LUCENTIS
RANIBIZUMAB
BLASTN
125156 0
Product
1
Approval Date
6302006
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE
05 MG005 ML ( 10 MGML )
Proper Name RANIDIZUMAB
BLASTN
125156 076
Product
2
Approval Date
8102012
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE
03 MG005 ML ( 6 MGML )
Trade Name
Proper Name
OCREVUS
OCRELIZUMAB
BLASTN
761053 0
Product
1
Approval Date
3282017
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
300 MG10 ML ( 30 MGML )
Trade Name
Proper Name
PERJETA
PERTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 20 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
125409 0 1 682012 420 MG14 ML ( 30 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name PULMOZYME
Proper Name DORNASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103532 0 1 12301993 25 MG25 ML ( 1 MGML )
SOLUTION INHALATION AMPULE
Trade Name RITUXAN
Proper Name RITUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103705 0 1 11261997 100 MG10 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
103705 0 2 11261997 500 MG50 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name RITUXAN HYCELA
Proper Name RITUXIMAB AND HYALURONIDASE HUMAN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761064 0 1 6222017 1400 MG AND 23400 U117 ML ( 11966 MG AND 2000 UML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
761064 0 2 6222017 1600 MG AND 26800 U134 ML ( 11966 MG AND 2000 UML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name TECENTRIQ
Proper Name ATEZOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761034 0 1 582016 1200 MG20 ML ( 60 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name TNKASE
March 2018 Page 21 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Proper Name TENECTEPLASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103909 0 1 622000 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103976 0 1 6202003 150 MG ( 150 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103948 0 1 572001
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML )
Trade Name
Proper Name
FABRAZYME
AGALSIDASE BETA
BLASTN
103979 0
Product
1
Approval Date
4242003
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
5 MG ( 5 MGVIAL )
103979 0 2 4242003
POWDER INTRAVENOUS SINGLE-DOSE VIAL
35 MG ( 35 MGVIAL )
Trade Name
Proper Name
LEMTRADA
ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 22 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENZYME CORP 1596
103948 5139 2 11142014 12 MG12 ML ( 10MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name LUMIZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125291 0 1 5242010 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name NUCALA
Proper Name MEPOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125526 0 1 11142015
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
TANZEUM
ALBIGLUTIDE
BLASTN
125431 0
Product
1
Approval Date
4152014
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS AUTOINJECTOR
30 MG ( 30 MGAUTOINJECTOR )
125431 0 2 4152014
POWDER SUBCUTANEOUS AUTOINJECTOR
50 MG ( 50 MGAUTOINJECTOR )
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name PEGASYS
Proper Name PEGINTERFERON ALFA 2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103964 5204 4 9292011 180 MCG05 ML ( 360 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 23 of 42
CDER Billable Biologic Product List
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Proper Name PEG-INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103964 0 1 10162002 180 MCGML ( 180 MCGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
103964 0 2 10162002 180 MCG05 ML ( 360 MCGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
103964 5204 3 9292011 135 MCG05 ML ( 270 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
ApplicantLicense No HORIZON PHARMA IRELAND LTD 2022
Trade Name ACTIMMUNE
Proper Name INTERFERON GAMMA-1B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103836 0 1 2251999 100 MCG05 ML ( 200 MCGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No HORIZON PHARMA RHEUMATOLOGY LLC 1998
Trade Name KRYSTEXXA
Proper Name PEGLOTICASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125293 0 1 9142010 8MGML ( 8MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 24 of 42
CDER Billable Biologic Product List
ApplicantLicense No HUMAN GENOME SCIENCES INC 1820
Trade Name BENLYSTA
Proper Name BELIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125370 0 1 392011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
120 MG ( 120 MGVIAL )
125370 0 2 392011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
400 MG ( 400 MGVIAL )
125370 0 3 392011
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )
125370 0 4 392011
SOLUTION SUBCUTANEOUS AUTOINJECTOR
200 MGML ( 200 MGML )
BLASTN
761043 0
Product
1
Approval Date
7202017
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )
Trade Name
Proper Name
RAXIBACUMAB
RAXIBACUMAB
BLASTN
125349 0
Product
1
Approval Date
12142012
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1700 MG34 ML ( 50 MGML )
ApplicantLicense No IMCLONE LLC 1695
Trade Name ERBITUX
Proper Name CETUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125084 0 1 2122004 100 MG50 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 25 of 42
CDER Billable Biologic Product List
ApplicantLicense No IMCLONE LLC 1695
125084 0 2 2122004 200 MG100 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No IMMUNEX CORP 1132
Trade Name ENBREL
Proper Name ETANERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103795 0 1 1121998
POWDER SUBCUTANEOUS MULTI-DOSE VIAL
25 MG ( 25 MGVIAL )
103795 5184 2 9272004
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
50 MGML ( 50 MGML )
103795 0 3 9272004
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MGML ( 50 MGML )
103795 5184 4 9272004
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
25 MG05 ML ( 50 MGML )
103795 5556 5 9142017
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MGML ( 50 MGML )
ApplicantLicense No IPSEN BIOPHARM LIMITED 1787
Trade Name DYSPORT
Proper Name ABOBOTULINUMTOXINA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125274 0 1 4292009
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
300 UNITS ( 300 UNITSVIAL )
125274 0 2 4292009
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
500 UNITS ( 500 UNITSVIAL )
March 2018 Page 26 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
Trade Name DARZALEX
Proper Name DARATUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761036 0 1 11162015
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG5 ML ( 20 MGML )
761036 0 2 11162015
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
400 MG20 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
103772 0
REMICADE
INFLIXIMAB
Approval Date Product
8241998 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
BLASTN
103575 0
REOPRO
ABCIXIMAB
Approval Date Product
12221994 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
10 MG5 ML ( 2 MGML )
Trade Name
Proper Name
BLASTN
125289 0
SIMPONI
GOLIMUMAB
Approval Date Product
4242009 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
50 MG05 ML ( 100 MGML )
125289 0 2 4242009
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MG05 ML ( 100 MGML )
125289 0 3 4242009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
100 MGML ( 100 MGML )
March 2018 Page 27 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
125289 0 4 4242009 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name SIMPONI ARIA
Proper Name GOLIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125433 0 1 7182013 50 MG4 ML ( 125 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name STELARA
Proper Name USTEKINUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125261 0 1 9252009 90 MGML ( 90 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125261 0 2 9252009 45 MG05 ML ( 90 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL amp PREFILLED SYRINGE
125261 0 3 9252009 130 MG26 ML ( 5 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761044 0 1 9232016 130 MG26 ML ( 5 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SYLVANT
Proper Name SILTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125496 0 1 4232014 100 MG ( 100 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125496 0 2 4232014 400 MG ( 400 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 28 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
Trade Name TREMFYA
Proper Name GUSELKUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761061 0 1 7132017 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No JAZZ PHARMACEUTICALS INC 1901
Trade Name ERWINAZE
Proper Name ASPARAGINASE ERWINIA CHRYSANTHEMI
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
105359 0 1 11182011 10000 IU ( 10000 IUVIAL )
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103770 0 1 6191998
SOLUTION INTRAMUSCULAR
50 MG05 ML ( 100 MGML )
SINGLE-DOSE VIAL
103770 0 2 6191998
SOLUTION INTRAMUSCULAR
100 MGML ( 100 MGML )
SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name ILUMYA
Proper Name TILDRAKIZUMAB-ASMN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761067 0 1 3202018 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name INTRON A
March 2018 Page 29 of 42
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103132 0 1 641986 10 MIU ( 10 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL INTRAVENOUS SINGLE-DOSE VIAL
103132 0 2 641986 18 MIU ( 18 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL
103132 0 3 641986 50 MIU ( 50 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL
103132 0 4 641986 228 MIU38 ML ( 6 MIUML )
SOLUTION INTRAMUSCULAR SUBCUTANEOUS MULTI-DOSE VIAL
103132 0 5 641986 32 MIU32 ML ( 10 MIUML )
SOLUTION INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL MULTI-DOSE VIAL
Trade Name KEYTRUDA
Proper Name PEMBROLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125514 0 1 942014 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125514 1 2 1152015 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 0 1 1192001 74 MCG ( 74 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SYLATRON
Proper Name PEGINTERFERON ALFA-2B
March 2018 Page 30 of 42
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 5153 2 3292011 296 MCG ( 296 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 3 3292011 444 MCG ( 444 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 4 3292011 888 MCG ( 888 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name ZINPLAVA
Proper Name BEZLOTOXUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761046 0 1 10212016 1000 MG40 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No MERZ PHARMACEUTICALS GMBH 1830
Trade Name XEOMIN
Proper Name INCOBOTULINUMTOXINA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125360 0 1 7302010
POWDER INTRAMUSCULAR
50 U ( 50 UVIAL )
SINGLE-DOSE VIAL
125360 0 2 7302010
POWDER INTRAMUSCULAR
100 U ( 100 UVIAL )
SINGLE-DOSE VIAL
125360 3 3 11202015
POWDER INTRAMUSCULAR
200 U ( 200 UVIAL )
SINGLE-DOSE VIAL
March 2018 Page 31 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
Trade Name ARZERRA
Proper Name OFATUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125326 0 1 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG5 ML ( 20 MGML )
125326 0 2 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1000 MG50 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
125504 0
COSENTYX
SECUKINUMAB
Approval Date Product
1212015 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
150 MG ( 150 MGVIAL )
125504 0 2 1212015
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MGML ( 150 MGML )
125504 0 3 1212015
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MGML ( 150 MGML )
Trade Name
Proper Name
BLASTN
125290 0
EXTAVIA
INTERFERON BETA-1B
Approval Date Product
8142009 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
03 MG ( 03 MGVIAL )
Trade Name
Proper Name
BLASTN
125319 0
ILARIS
CANAKINUMAB
Approval Date Product
6172009 1
PotencyDosage FormRoutePresentation
180 MGVIAL ( 180 MGVIAL )
March 2018 Page 32 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
125319 88 2 12222016 150 MG ( 150 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
125319 0 3 12222016 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SIMULECT
Proper Name BASILIXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103764 0 1 5121998 10 MG ( 10 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
103764 0 2 5121998 20 MG ( 20 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No NPS PHARMACEUTICALS INC 1908
Trade Name NATPARA
Proper Name PARATHYROID HORMONE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 33 of 42
CDER Billable Biologic Product List
ApplicantLicense No PROMETHEUS LABORATORIES INC 1848
Trade Name PROLEUKIN
Proper Name ALDESLEUKIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103293 0 1 551992 22 MIU ( 22 MIUVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760
Trade Name ARCALYST
Proper Name RILONACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125249 0 1 2272008
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
220MG ( 220MGVIAL )
Trade Name
Proper Name
DUPIXENT
DUPILUMAB
BLASTN
761055 0
Product
1
Approval Date
3282017
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
300 MG2 ML ( 150 MGML )
Trade Name
Proper Name
EYLEA
AFLIBERCEPT
BLASTN
125387 0
Product
1
Approval Date
11182011
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
2 MG005 ML ( 40 MGML )
March 2018 Page 34 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Trade Name ELITEK
Proper Name RASBURICASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103946 0 1 7122002
POWDER INTRAVENOUS SINGLE-DOSE VIAL
15 MG ( 15 MGVIAL )
103946 5020 2 162006
POWDER INTRAVENOUS SINGLE-DOSE VIAL
75 MG ( 75 MGVIAL )
Trade Name
Proper Name
BLASTN
761037 0
KEVZARA
SARILUMAB
Approval Date Product
5222017 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MG114 ML ( 13158 MGML )
761037 0 2 5222017
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MG114 ML ( 17544 MGML )
761037 1 3 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MG114 ML ( 13158 MGML )
761037 1 4 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
200 MG114 ML ( 17544 MGML )
Trade Name
Proper Name
BLASTN
103362 0
LEUKINE
SARGRAMOSTIM
Approval Date Product
351991 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
250 MCG ( 250 MCGVIAL )
103362 0 2 351991
SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL
500 MCGML ( 500 MCGML )
Trade Name PRALUENT
March 2018 Page 35 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Proper Name ALIROCUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125559 0 1 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 2 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 3 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125559 0 4 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name ZALTRAP
Proper Name ZIV-AFLIBERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125418 0 1 832012 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125418 0 2 832012 200 MG8 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SEATTLE GENETICS INC 1853
Trade Name ADCETRIS
Proper Name BRENTUXIMAB VEDOTIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125388 1 1 8192011 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 36 of 42
CDER Billable Biologic Product List
ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593
Trade Name ELAPRASE
Proper Name IDURSULFASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125151 0 1 7242006 6 MG3 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SICOR BIOTECH UAB 1803
Trade Name GRANIX
Proper Name TBO-FILGRASTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125294 0 1 8292012
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
300 MCG0 5 ML ( 600 MCGML )
125294 0 2 8292012
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
480 MCG08 ML ( 600 MCGML )
ApplicantLicense No SMITH AND NEPHEW INC 2004
Trade Name REGRANEX
Proper Name BECAPLERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103691 0 1 12161997
GEL TOPICAL
100 UG ( 100 UGGM )
Trade Name
Proper Name
SANTYL
COLLAGENASE
BLASTN
101995 0
Product
1
Approval Date
641965
PotencyDosage FormRoutePresentation
OINTMENT TOPICAL
30 G amp 90 G TUBE ( 250 UGRAM )
March 2018 Page 37 of 42
CDER Billable Biologic Product List
ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718
Trade Name MYOBLOC
Proper Name RIMABOTULINUM TOXIN B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103846 0 1 1282002
SOLUTION INTRAMUSCULAR
2500 IU05 ML ( 5000 IUML )
SINGLE-DOSE VIAL
103846 0 3 1282002
SOLUTION INTRAMUSCULAR
10000 IU2 ML ( 5000 IUML )
SINGLE-DOSE VIAL
Proper Name RIMABOTULINUMTOXINB
BLASTN
103846 0
Product
2
Approval Date
1282002
PotencyDosage FormRoutePresentation
SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL
5000 IUML ( 5000 IUML )
ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832
Trade Name ZEVALIN
Proper Name IBRITUMOMAB TIUXETAN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125019 0 1 2192002 32 MG2 ML ( 16 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
Trade Name KEPIVANCE
Proper Name PALIFERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125103 0 1 12152004 625 MG ( 625 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name KINERET
Proper Name ANAKINRA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 38 of 42
CDER Billable Biologic Product List
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898
Trade Name ENTYVIO
Proper Name VEDOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125476 0 1 5202014 300 MG ( 300 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No TEVA RESPIRATORY LLC 2047
Trade Name CINQAIR
Proper Name RESLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761033 0 1 3232016 100 MG10 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No THERATECHNOLOGIES INC 2091
Trade Name TROGARZO
Proper Name IBALIZUMAB-UIYK
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761065 0 1 362018 200 MG133 ML ( 150 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 39 of 42
CDER Billable Biologic Product List
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
0375 MG03 ML ( 125 MGML )2222017 125422 038 1
ApplicantLicense No UCB INC 1736
Trade Name CIMZIA
Proper Name CERTOLIZUMAB PEGOL
BLASTN Approval Date PotencyDosage FormRoutePresentation Product
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
200 MG ( 200 MGVIAL ) 4222008 125160 0 1
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )5132009 125160 080 2
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
Trade Name CRYSVITA
Proper Name BUROSUMAB-TWZA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761068 0 1 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
10 MGML ( 10 MGML )
761068 0 2 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
20 MGML ( 20 MGML )
761068 0
Trade Name
Proper Name
BLASTN
March 2018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML ) 4172018 3
MEPSEVII
VESTRONIDASE ALFA-VJBK
Approval Date PotencyDosage FormRoutePresentation Product
Page 40 of 42
CDER Billable Biologic Product List
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
761047 0 1 11152017 10 MG5 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No UNITED THERAPEUTICS CORP 1993
Trade Name UNITUXIN
Proper Name DINUTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125516 0 1 3102015 175 MG5 ML ( 35 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053
Trade Name SILIQ
Proper Name BRODALUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761032 0 1 2152017 210 MG15 ML ( 140 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 41 of 42
CDER Billable Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No WYETH PHARMACEUTICALS INC 0003
Trade Name BESPONSA
Proper Name INOTUZUMAB OZOGAMICIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761040 0 1 8172017 09 MG ( 09 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 42 of 42
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 1 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
9172001 103951 0 26
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
200 MCGML ( 200 MCGML ) 09272012
103951 0 27 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
200 MCG04 ML ( 500 MCGML ) 09272012
103951 0 28 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
300 MCGML ( 300 MCGML ) 09272012
103951 0 29 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
300 MCG06 ML ( 500 MCGML ) 09272012
103951 0 30 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
500 MCGML ( 500 MCGML ) 09272012
ApplicantLicense No ASTELLAS PHARMACEUTICALS US INC 1748
Trade Name AMEVIVE
Proper Name ALEFACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125036 0 1 1302003 75 MGVIAL ( 75 MGVIAL ) 09242008
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
125036 0 2 1302003 15 MGVIAL ( 15 MGVIAL ) 09282012
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No BOEHRINGER INGELHEIM PHARMA KG 1251
Trade Name VERLUMA
Proper Name NOFETUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103769 0 1 10131998 10 MGML ( 10 MGML ) 08132013
INTRAVENOUS
March 2018 Page 2 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No CENTOCOR ORTHO BIOTECH PRODUCTS LP 1824
Trade Name ORTHOCLONE OKT3
Proper Name MUROMONAB-CD3
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103463 0 1 9141992 1 MGML ( 1 MGML ) 01112012
SOLUTION INTRAVENOUS AMPULE
ApplicantLicense No EISAI INCORPORATED 1862
Trade Name ONTAK
Proper Name DENILEUKIN DIFTITOX
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103767 0 1 251999 300 MCG2 ML ( 150 MCGML ) 01302014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No ELI LILLY AND CO 1611
Trade Name XIGRIS
Proper Name DROTRECOGIN ALFA (ACTIVATED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125029 0 1 11212001 5 MGVIAL ( 5 MGVIAL ) 10262011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125029 0 2 11212001 20 MGVIAL ( 20 MGVIAL ) 10102011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GENENTECH INC 1048
Trade Name RAPTIVA
Proper Name EFALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125075 0 1 10272003 125 MGVIAL ( 125 MGVIAL ) 09012009
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
March 2018 Page 3 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103976 0 2 6202003 125 MGVIAL ( 125 MGVIAL ) 08252016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103948 0 3 572001 10 MGVIAL ( 10 MGVIAL ) 07062011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name MYOZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125141 0 1 4282006 50 MGVIAL ( 50 MGVIAL ) 10172014
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name BEXXAR THERAPEUTIC REGIME
Proper Name TOSITUMOMAB AND IODINE I-131 TOSITUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125011 0 1 6272003 01 MGML I-131 TOSITUMOMAB ( 01 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 2 6272003 11 MGML I-131 TOSITUMOMAB ( 11 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 3 6272003 14 MGML TOSITUMOMAB ( 14 MGML 03102014 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 4 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No HEMISPHERX BIOPHARMA INC 1703
Trade Name ALFERON N INJECTION
Proper Name INTERFERON ALFA-N3 (HUMAN LEUKOCYTE DERIVED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103158 0 1 10101989 5 MIUVIAL ( 5 MIUVIAL ) 06272013
SOLUTION INTRALESIONAL MULTI-DOSE VIAL
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name ROFERON A
Proper Name INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103145 0 1 641986 3 MIU05 ML ( 3 MIU05 ML ) 06012009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name ZENAPAX
Proper Name DACLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103749 0 1 12101997 25 MG5 ML ( 25 MG5 ML ) 07072011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No KADMON PHARMACEUTICALS LLC 1867
Trade Name INFERGEN
Proper Name INTERFERON ALFACON-1
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103663 0 1 1061997 9 MCG03 ML ( 30 MCGML ) 07252013
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 5 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103770 0 3 6191998 50 MGVIAL ( 50 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
103770 0 4 6191998 100 MGVIAL ( 100 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name INTRON A
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103132 0 6 641986 10 MIUML ( 10 MIUML ) 09232013
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103132 0 7 641986 225 MIU15 ML ( 225 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 8 641986 375 MIU15 ML ( 375 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 9 641986 75 MIU15 ML ( 75 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103949 0 5 1192001 675 MCGPEN ( 675 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 6 1192001 108 MCGPEN ( 108 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
March 2018 Page 6 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name PEGINTRON
103949 0 7 1192001 1184 MCGVIAL ( 1184 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 8 1192001 162 MCGPEN ( 162 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 9 1192001 1776 MCGVIAL ( 1776 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 10 1192001 2025 MCGPEN ( 2025 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 11 1192001 222 MCGVIAL ( 222 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No PALATIN TECHNOLOGIES INC 1588
Trade Name NEUTROSPEC TECHNETIUM (99M TC)
Proper Name FANOLESOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103928 0 1 722004 025 MGVIAL ( 025 MGVIAL ) 09222008
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No RECORDATI RARE DISEASES INC 1899
Trade Name ELSPAR
Proper Name ASPARAGINASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
101063 0 1 1101978 10000 IU ( 10000 IUVIAL ) 04092014
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
March 2018 Page 7 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No SCHERING CORP 0994
Trade Name PEGINTRONREBETOL COMBO PACK
Proper Name PEGINTERFERON ALFA-2B AND RIBAVIRIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125196 0 1 6132008 ( 4 (120 MCG05ML) REDIPEN amp 140 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 2 6132008 ( 4 (150 MCG05ML) REDIPEN amp 168 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 3 6132008 ( 4 (150 MCG05ML) REDIPEN amp 196 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 4 6132008 ( 4 (50 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 5 6132008 ( 4 (80 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125422 0 2 10172012 05 MG ( 25 MGML ) 08082017
SOLUTION INTRAVETREAL SINGLE-DOSE VIAL
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125164 0 10 11142007 50 MCGML ( 50 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 8 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
125164 0 11 11142007 100 MCGML ( 100 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 12 11142007 200 MCGML ( 200 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 13 11142007 300 MCGML ( 300 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 14 11142007 400 MCGML ( 400 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 15 11142007 400 MCG06 ML ( 400 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 16 11142007 600 MCGML ( 600 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 17 11142007 600 MCG06 ML ( 600 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 18 11142007 800 MCG06 ML ( 800 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 19 11142007 1000 MCGML ( 1000 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 9 of 9
CDER Billable Biologic Product List
ApplicantLicense No BIOMARIN PHARMACEUTICAL INC 1649
Trade Name ALDURAZYME
Proper Name LARONIDASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125058 0 1 4302003
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
29 MG5 ML ( 058 MGML )
Trade Name
Proper Name
BRINEURA
CERLIPONASE ALFA
BLASTN
761052 0
Product
1
Approval Date
4272017
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENTRICULAR SINGLE-DOSE VIAL
150 MG5 ML ( 30 MGML )
Trade Name
Proper Name
NAGLAZYME
GALSULFASE
BLASTN
125117 0
Product
1
Approval Date
5312005
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
5 MG 5ML ( 1 MGML )
Trade Name
Proper Name
VIMIZIM
ELOSULFASE ALFA
BLASTN
125460 0
Product
1
Approval Date
2142014
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
5 MG5 ML ( 1 MGML )
ApplicantLicense No BOEHRINGER INGELHEIM PHARMACEUTICALS INC 2006
Trade Name PRAXBIND
Proper Name IDARUCIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761025 0 1 10162015 2500 MG50 ML ( 50 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 12 of 42
CDER Billable Biologic Product List
ApplicantLicense No BRISTOL MYERS SQUIBB CO 1713
Trade Name EMPLICITI
Proper Name ELOTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761035 0 1 11302015
POWDER INTRAVENOUS SINGLE-DOSE VIAL
300 MG ( 300 MGVIAL )
761035 0 2 11302015
POWDER INTRAVENOUS SINGLE-DOSE VIAL
400 MG ( 400 MGVIAL )
Trade Name
Proper Name
BLASTN
125288 0
NULOJIX
BELATACEPT
Approval Date Product
6152011 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
250 MG ( 250 MGVIAL )
Trade Name
Proper Name
BLASTN
125554 0
OPDIVO
NIVOLUMAB
Approval Date Product
12222014 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
40 MG4 ML ( 10 MGML )
125554 0 2 12222014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG10 ML ( 10 MGML )
125554 0 3 12222014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
240 MG24 ML ( 10 MGML )
Trade Name
Proper Name
BLASTN
125118 0
ORENCIA
ABATACEPT
Approval Date Product
12232005 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
250 MG ( 250 MGVIAL )
March 2018 Page 13 of 42
CDER Billable Biologic Product List
ApplicantLicense No BRISTOL MYERS SQUIBB CO 1713
125118 122 2 7292011 50 MG04 ML ( 125 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125118 122 3 7292011 875 MG07 ML ( 125 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125118 122 4 7292011 125 MGML ( 125 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125118 122 5 7292011 125 MGML ( 125 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name YERVOY
Proper Name IPILIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125377 0 1 3252011 50 MG10 ML ( 5 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125377 0 2 3252011 200 MG40 ML ( 5 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No BTG INTERNATIONAL INC 1861
Trade Name VORAXAZE
Proper Name GLUCARPIDASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125327 0 1 1172012 1000 U ( 1000 UVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 14 of 42
CDER Billable Biologic Product List
ApplicantLicense No DYAX CORPORATION 1789
Trade Name KALBITOR
Proper Name ECALLANTIDE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125277 0 1 1212009 10 MGML ( 10 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No EKR THERAPEUTICS INC 1814
Trade Name RETAVASE
Proper Name RETEPLASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103786 0 1 561998 10 U ( 10 UVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No ELI LILLY AND CO 1891
Trade Name CYRAMZA
Proper Name RAMUCIRUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125477 0 1 4212014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG10 ML ( 10 MGML )
125477 0 2 4212014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
500 MG50 ML ( 10 MGML )
Trade Name
Proper Name
BLASTN
761038 0
LARTRUVO
OLARATUMAB
Approval Date Product
10192016 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
500 MG50 ML ( 10 MGML )
761038 0 2 10192016
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
190 MG19 ML ( 10 MGML )
March 2018 Page 15 of 42
CDER Billable Biologic Product List
ApplicantLicense No ELI LILLY AND CO 1891
Trade Name PORTRAZZA
Proper Name NECITUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125547 0 1 11242015
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
800 MG50 ML ( 16 MGML )
Trade Name
Proper Name
TALTZ
IXEKIZUMAB
BLASTN
125521 0
Product
1
Approval Date
3222016
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
80 MGML ( 80 MGML )
125521 0 2 3222016
SOLUTION SUBCUTANEOUS AUTOINJECTOR
80 MGML ( 80 MGML )
Trade Name
Proper Name
TRULICITY
DULAGLUTIDE
BLASTN
125469 0
Product
1
Approval Date
9182014
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
075 MG05 ML ( 075 MG05 ML )
125469 0 2 9182014
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
15 MG05 ML ( 15 MG05 ML )
125469 0 3 9182014
SOLUTION SUBCUTANEOUS AUTOINJECTOR
075 MG05 ML ( 075 MG05 ML )
125469 0 4 9182014
SOLUTION SUBCUTANEOUS AUTOINJECTOR
15 MG05 ML ( 15 MG05 ML )
March 2018 Page 16 of 42
CDER Billable Biologic Product List
ApplicantLicense No ELUSYS THERAPEUTICS INC 1907
Trade Name ANTHIM
Proper Name OBILTOXAXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125509 1 1 3182016 600 MG6 ML ( 100 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No EMD SERONO INC 1773
Trade Name BAVENCIO
Proper Name AVELUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761049 0 1 3232017
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
200 MG10 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
103780 0
REBIF
INTERFERON BETA 1A
Approval Date Product
372002 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
88 MCG02 ML ( 44 MCGML )
103780 0 2 372002
SOLUTION SUBCUTANEOUS AUTOINJECTOR
88 MCG02 ML ( 44 MCGML )
103780 0 3 372002
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
22 MCG05 ML ( 44 MCGML )
103780 0 4 372002
SOLUTION SUBCUTANEOUS AUTOINJECTOR
22 MCG05 ML ( 44 MCGML )
103780 0 5 372002
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
44 MCG05 ML ( 88 MCGML )
103780 0 6 372002
SOLUTION SUBCUTANEOUS AUTOINJECTOR
44 MCG05 ML ( 88 MCGML )
March 2018 Page 17 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name ACTEMRA
Proper Name TOCILIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125276 0 1 182010
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
80 MG4 ML ( 20 MGML )
125276 0 2 182010
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
200 MG10 ML ( 20 MGML )
125276 0 3 182010
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
400 MG20 ML ( 20 MGML )
BLASTN
125472 1
Product
1
Approval Date
10212013
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
162 MG09 ML ( 179 MGML )
Trade Name
Proper Name
BLASTN
103172 0
ACTIVASE
ALTEPLASE
Approval Date Product
11131987 2
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
50 MG ( 50 MGVIAL )
103172 0 3 11131987
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
BLASTN
125085 0
AVASTIN
BEVACIZUMAB
Approval Date Product
2262004 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG4 ML ( 25 MGML )
125085 0 2 2262004
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
400 MG16 ML ( 25 MGML )
March 2018 Page 18 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name CATHFLO ACTIVASE
Proper Name ALTEPLASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103172 0 1 11131987
POWDER INTRACATHETER SINGLE-DOSE VIAL
2 MG ( 2 MGVIAL )
Trade Name
Proper Name
BLASTN
125486 0
GAZYVA
OBINUYUZUMAB
Approval Date Product
1112013 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1000 MG40 ML ( 25 MGML )
Trade Name
Proper Name
BLASTN
761083 0
HEMLIBRA
EMICIZUMAB-KXWH
Approval Date Product
11162017 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML )
761083 0 2 11162017
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
60 MG04 ML ( 150 MGML )
761083 0 3 11162017
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
105 MG07 ML ( 150 MGML )
761083 0 4 11162017
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
150 MGML ( 150 MGML )
Trade Name
Proper Name
BLASTN
103792 0
HERCEPTIN
TRASTUZUMAB
Approval Date Product
9251998 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS MULTI-DOSE VIAL
420 MG ( 420 MGVIAL )
March 2018 Page 19 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
103792 5336 2 2102017 150 MG ( 150 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name KADCYLA
Proper Name ADO-TRASIUZUMAB EMTANSINE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125427 0 1 2222013
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
125427 0 2 2222013
POWDER INTRAVENOUS SINGLE-DOSE VIAL
160 MG ( 160 MGVIAL )
Trade Name
Proper Name
LUCENTIS
RANIBIZUMAB
BLASTN
125156 0
Product
1
Approval Date
6302006
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE
05 MG005 ML ( 10 MGML )
Proper Name RANIDIZUMAB
BLASTN
125156 076
Product
2
Approval Date
8102012
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE
03 MG005 ML ( 6 MGML )
Trade Name
Proper Name
OCREVUS
OCRELIZUMAB
BLASTN
761053 0
Product
1
Approval Date
3282017
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
300 MG10 ML ( 30 MGML )
Trade Name
Proper Name
PERJETA
PERTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 20 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
125409 0 1 682012 420 MG14 ML ( 30 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name PULMOZYME
Proper Name DORNASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103532 0 1 12301993 25 MG25 ML ( 1 MGML )
SOLUTION INHALATION AMPULE
Trade Name RITUXAN
Proper Name RITUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103705 0 1 11261997 100 MG10 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
103705 0 2 11261997 500 MG50 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name RITUXAN HYCELA
Proper Name RITUXIMAB AND HYALURONIDASE HUMAN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761064 0 1 6222017 1400 MG AND 23400 U117 ML ( 11966 MG AND 2000 UML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
761064 0 2 6222017 1600 MG AND 26800 U134 ML ( 11966 MG AND 2000 UML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name TECENTRIQ
Proper Name ATEZOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761034 0 1 582016 1200 MG20 ML ( 60 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name TNKASE
March 2018 Page 21 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Proper Name TENECTEPLASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103909 0 1 622000 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103976 0 1 6202003 150 MG ( 150 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103948 0 1 572001
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML )
Trade Name
Proper Name
FABRAZYME
AGALSIDASE BETA
BLASTN
103979 0
Product
1
Approval Date
4242003
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
5 MG ( 5 MGVIAL )
103979 0 2 4242003
POWDER INTRAVENOUS SINGLE-DOSE VIAL
35 MG ( 35 MGVIAL )
Trade Name
Proper Name
LEMTRADA
ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 22 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENZYME CORP 1596
103948 5139 2 11142014 12 MG12 ML ( 10MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name LUMIZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125291 0 1 5242010 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name NUCALA
Proper Name MEPOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125526 0 1 11142015
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
TANZEUM
ALBIGLUTIDE
BLASTN
125431 0
Product
1
Approval Date
4152014
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS AUTOINJECTOR
30 MG ( 30 MGAUTOINJECTOR )
125431 0 2 4152014
POWDER SUBCUTANEOUS AUTOINJECTOR
50 MG ( 50 MGAUTOINJECTOR )
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name PEGASYS
Proper Name PEGINTERFERON ALFA 2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103964 5204 4 9292011 180 MCG05 ML ( 360 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 23 of 42
CDER Billable Biologic Product List
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Proper Name PEG-INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103964 0 1 10162002 180 MCGML ( 180 MCGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
103964 0 2 10162002 180 MCG05 ML ( 360 MCGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
103964 5204 3 9292011 135 MCG05 ML ( 270 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
ApplicantLicense No HORIZON PHARMA IRELAND LTD 2022
Trade Name ACTIMMUNE
Proper Name INTERFERON GAMMA-1B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103836 0 1 2251999 100 MCG05 ML ( 200 MCGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No HORIZON PHARMA RHEUMATOLOGY LLC 1998
Trade Name KRYSTEXXA
Proper Name PEGLOTICASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125293 0 1 9142010 8MGML ( 8MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 24 of 42
CDER Billable Biologic Product List
ApplicantLicense No HUMAN GENOME SCIENCES INC 1820
Trade Name BENLYSTA
Proper Name BELIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125370 0 1 392011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
120 MG ( 120 MGVIAL )
125370 0 2 392011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
400 MG ( 400 MGVIAL )
125370 0 3 392011
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )
125370 0 4 392011
SOLUTION SUBCUTANEOUS AUTOINJECTOR
200 MGML ( 200 MGML )
BLASTN
761043 0
Product
1
Approval Date
7202017
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )
Trade Name
Proper Name
RAXIBACUMAB
RAXIBACUMAB
BLASTN
125349 0
Product
1
Approval Date
12142012
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1700 MG34 ML ( 50 MGML )
ApplicantLicense No IMCLONE LLC 1695
Trade Name ERBITUX
Proper Name CETUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125084 0 1 2122004 100 MG50 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 25 of 42
CDER Billable Biologic Product List
ApplicantLicense No IMCLONE LLC 1695
125084 0 2 2122004 200 MG100 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No IMMUNEX CORP 1132
Trade Name ENBREL
Proper Name ETANERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103795 0 1 1121998
POWDER SUBCUTANEOUS MULTI-DOSE VIAL
25 MG ( 25 MGVIAL )
103795 5184 2 9272004
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
50 MGML ( 50 MGML )
103795 0 3 9272004
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MGML ( 50 MGML )
103795 5184 4 9272004
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
25 MG05 ML ( 50 MGML )
103795 5556 5 9142017
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MGML ( 50 MGML )
ApplicantLicense No IPSEN BIOPHARM LIMITED 1787
Trade Name DYSPORT
Proper Name ABOBOTULINUMTOXINA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125274 0 1 4292009
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
300 UNITS ( 300 UNITSVIAL )
125274 0 2 4292009
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
500 UNITS ( 500 UNITSVIAL )
March 2018 Page 26 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
Trade Name DARZALEX
Proper Name DARATUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761036 0 1 11162015
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG5 ML ( 20 MGML )
761036 0 2 11162015
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
400 MG20 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
103772 0
REMICADE
INFLIXIMAB
Approval Date Product
8241998 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
BLASTN
103575 0
REOPRO
ABCIXIMAB
Approval Date Product
12221994 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
10 MG5 ML ( 2 MGML )
Trade Name
Proper Name
BLASTN
125289 0
SIMPONI
GOLIMUMAB
Approval Date Product
4242009 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
50 MG05 ML ( 100 MGML )
125289 0 2 4242009
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MG05 ML ( 100 MGML )
125289 0 3 4242009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
100 MGML ( 100 MGML )
March 2018 Page 27 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
125289 0 4 4242009 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name SIMPONI ARIA
Proper Name GOLIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125433 0 1 7182013 50 MG4 ML ( 125 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name STELARA
Proper Name USTEKINUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125261 0 1 9252009 90 MGML ( 90 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125261 0 2 9252009 45 MG05 ML ( 90 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL amp PREFILLED SYRINGE
125261 0 3 9252009 130 MG26 ML ( 5 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761044 0 1 9232016 130 MG26 ML ( 5 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SYLVANT
Proper Name SILTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125496 0 1 4232014 100 MG ( 100 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125496 0 2 4232014 400 MG ( 400 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 28 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
Trade Name TREMFYA
Proper Name GUSELKUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761061 0 1 7132017 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No JAZZ PHARMACEUTICALS INC 1901
Trade Name ERWINAZE
Proper Name ASPARAGINASE ERWINIA CHRYSANTHEMI
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
105359 0 1 11182011 10000 IU ( 10000 IUVIAL )
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103770 0 1 6191998
SOLUTION INTRAMUSCULAR
50 MG05 ML ( 100 MGML )
SINGLE-DOSE VIAL
103770 0 2 6191998
SOLUTION INTRAMUSCULAR
100 MGML ( 100 MGML )
SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name ILUMYA
Proper Name TILDRAKIZUMAB-ASMN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761067 0 1 3202018 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name INTRON A
March 2018 Page 29 of 42
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103132 0 1 641986 10 MIU ( 10 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL INTRAVENOUS SINGLE-DOSE VIAL
103132 0 2 641986 18 MIU ( 18 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL
103132 0 3 641986 50 MIU ( 50 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL
103132 0 4 641986 228 MIU38 ML ( 6 MIUML )
SOLUTION INTRAMUSCULAR SUBCUTANEOUS MULTI-DOSE VIAL
103132 0 5 641986 32 MIU32 ML ( 10 MIUML )
SOLUTION INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL MULTI-DOSE VIAL
Trade Name KEYTRUDA
Proper Name PEMBROLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125514 0 1 942014 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125514 1 2 1152015 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 0 1 1192001 74 MCG ( 74 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SYLATRON
Proper Name PEGINTERFERON ALFA-2B
March 2018 Page 30 of 42
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 5153 2 3292011 296 MCG ( 296 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 3 3292011 444 MCG ( 444 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 4 3292011 888 MCG ( 888 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name ZINPLAVA
Proper Name BEZLOTOXUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761046 0 1 10212016 1000 MG40 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No MERZ PHARMACEUTICALS GMBH 1830
Trade Name XEOMIN
Proper Name INCOBOTULINUMTOXINA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125360 0 1 7302010
POWDER INTRAMUSCULAR
50 U ( 50 UVIAL )
SINGLE-DOSE VIAL
125360 0 2 7302010
POWDER INTRAMUSCULAR
100 U ( 100 UVIAL )
SINGLE-DOSE VIAL
125360 3 3 11202015
POWDER INTRAMUSCULAR
200 U ( 200 UVIAL )
SINGLE-DOSE VIAL
March 2018 Page 31 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
Trade Name ARZERRA
Proper Name OFATUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125326 0 1 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG5 ML ( 20 MGML )
125326 0 2 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1000 MG50 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
125504 0
COSENTYX
SECUKINUMAB
Approval Date Product
1212015 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
150 MG ( 150 MGVIAL )
125504 0 2 1212015
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MGML ( 150 MGML )
125504 0 3 1212015
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MGML ( 150 MGML )
Trade Name
Proper Name
BLASTN
125290 0
EXTAVIA
INTERFERON BETA-1B
Approval Date Product
8142009 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
03 MG ( 03 MGVIAL )
Trade Name
Proper Name
BLASTN
125319 0
ILARIS
CANAKINUMAB
Approval Date Product
6172009 1
PotencyDosage FormRoutePresentation
180 MGVIAL ( 180 MGVIAL )
March 2018 Page 32 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
125319 88 2 12222016 150 MG ( 150 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
125319 0 3 12222016 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SIMULECT
Proper Name BASILIXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103764 0 1 5121998 10 MG ( 10 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
103764 0 2 5121998 20 MG ( 20 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No NPS PHARMACEUTICALS INC 1908
Trade Name NATPARA
Proper Name PARATHYROID HORMONE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 33 of 42
CDER Billable Biologic Product List
ApplicantLicense No PROMETHEUS LABORATORIES INC 1848
Trade Name PROLEUKIN
Proper Name ALDESLEUKIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103293 0 1 551992 22 MIU ( 22 MIUVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760
Trade Name ARCALYST
Proper Name RILONACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125249 0 1 2272008
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
220MG ( 220MGVIAL )
Trade Name
Proper Name
DUPIXENT
DUPILUMAB
BLASTN
761055 0
Product
1
Approval Date
3282017
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
300 MG2 ML ( 150 MGML )
Trade Name
Proper Name
EYLEA
AFLIBERCEPT
BLASTN
125387 0
Product
1
Approval Date
11182011
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
2 MG005 ML ( 40 MGML )
March 2018 Page 34 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Trade Name ELITEK
Proper Name RASBURICASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103946 0 1 7122002
POWDER INTRAVENOUS SINGLE-DOSE VIAL
15 MG ( 15 MGVIAL )
103946 5020 2 162006
POWDER INTRAVENOUS SINGLE-DOSE VIAL
75 MG ( 75 MGVIAL )
Trade Name
Proper Name
BLASTN
761037 0
KEVZARA
SARILUMAB
Approval Date Product
5222017 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MG114 ML ( 13158 MGML )
761037 0 2 5222017
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MG114 ML ( 17544 MGML )
761037 1 3 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MG114 ML ( 13158 MGML )
761037 1 4 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
200 MG114 ML ( 17544 MGML )
Trade Name
Proper Name
BLASTN
103362 0
LEUKINE
SARGRAMOSTIM
Approval Date Product
351991 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
250 MCG ( 250 MCGVIAL )
103362 0 2 351991
SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL
500 MCGML ( 500 MCGML )
Trade Name PRALUENT
March 2018 Page 35 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Proper Name ALIROCUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125559 0 1 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 2 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 3 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125559 0 4 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name ZALTRAP
Proper Name ZIV-AFLIBERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125418 0 1 832012 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125418 0 2 832012 200 MG8 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SEATTLE GENETICS INC 1853
Trade Name ADCETRIS
Proper Name BRENTUXIMAB VEDOTIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125388 1 1 8192011 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 36 of 42
CDER Billable Biologic Product List
ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593
Trade Name ELAPRASE
Proper Name IDURSULFASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125151 0 1 7242006 6 MG3 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SICOR BIOTECH UAB 1803
Trade Name GRANIX
Proper Name TBO-FILGRASTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125294 0 1 8292012
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
300 MCG0 5 ML ( 600 MCGML )
125294 0 2 8292012
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
480 MCG08 ML ( 600 MCGML )
ApplicantLicense No SMITH AND NEPHEW INC 2004
Trade Name REGRANEX
Proper Name BECAPLERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103691 0 1 12161997
GEL TOPICAL
100 UG ( 100 UGGM )
Trade Name
Proper Name
SANTYL
COLLAGENASE
BLASTN
101995 0
Product
1
Approval Date
641965
PotencyDosage FormRoutePresentation
OINTMENT TOPICAL
30 G amp 90 G TUBE ( 250 UGRAM )
March 2018 Page 37 of 42
CDER Billable Biologic Product List
ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718
Trade Name MYOBLOC
Proper Name RIMABOTULINUM TOXIN B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103846 0 1 1282002
SOLUTION INTRAMUSCULAR
2500 IU05 ML ( 5000 IUML )
SINGLE-DOSE VIAL
103846 0 3 1282002
SOLUTION INTRAMUSCULAR
10000 IU2 ML ( 5000 IUML )
SINGLE-DOSE VIAL
Proper Name RIMABOTULINUMTOXINB
BLASTN
103846 0
Product
2
Approval Date
1282002
PotencyDosage FormRoutePresentation
SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL
5000 IUML ( 5000 IUML )
ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832
Trade Name ZEVALIN
Proper Name IBRITUMOMAB TIUXETAN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125019 0 1 2192002 32 MG2 ML ( 16 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
Trade Name KEPIVANCE
Proper Name PALIFERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125103 0 1 12152004 625 MG ( 625 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name KINERET
Proper Name ANAKINRA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 38 of 42
CDER Billable Biologic Product List
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898
Trade Name ENTYVIO
Proper Name VEDOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125476 0 1 5202014 300 MG ( 300 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No TEVA RESPIRATORY LLC 2047
Trade Name CINQAIR
Proper Name RESLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761033 0 1 3232016 100 MG10 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No THERATECHNOLOGIES INC 2091
Trade Name TROGARZO
Proper Name IBALIZUMAB-UIYK
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761065 0 1 362018 200 MG133 ML ( 150 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 39 of 42
CDER Billable Biologic Product List
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
0375 MG03 ML ( 125 MGML )2222017 125422 038 1
ApplicantLicense No UCB INC 1736
Trade Name CIMZIA
Proper Name CERTOLIZUMAB PEGOL
BLASTN Approval Date PotencyDosage FormRoutePresentation Product
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
200 MG ( 200 MGVIAL ) 4222008 125160 0 1
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )5132009 125160 080 2
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
Trade Name CRYSVITA
Proper Name BUROSUMAB-TWZA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761068 0 1 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
10 MGML ( 10 MGML )
761068 0 2 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
20 MGML ( 20 MGML )
761068 0
Trade Name
Proper Name
BLASTN
March 2018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML ) 4172018 3
MEPSEVII
VESTRONIDASE ALFA-VJBK
Approval Date PotencyDosage FormRoutePresentation Product
Page 40 of 42
CDER Billable Biologic Product List
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
761047 0 1 11152017 10 MG5 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No UNITED THERAPEUTICS CORP 1993
Trade Name UNITUXIN
Proper Name DINUTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125516 0 1 3102015 175 MG5 ML ( 35 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053
Trade Name SILIQ
Proper Name BRODALUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761032 0 1 2152017 210 MG15 ML ( 140 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 41 of 42
CDER Billable Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No WYETH PHARMACEUTICALS INC 0003
Trade Name BESPONSA
Proper Name INOTUZUMAB OZOGAMICIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761040 0 1 8172017 09 MG ( 09 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 42 of 42
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 1 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
9172001 103951 0 26
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
200 MCGML ( 200 MCGML ) 09272012
103951 0 27 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
200 MCG04 ML ( 500 MCGML ) 09272012
103951 0 28 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
300 MCGML ( 300 MCGML ) 09272012
103951 0 29 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
300 MCG06 ML ( 500 MCGML ) 09272012
103951 0 30 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
500 MCGML ( 500 MCGML ) 09272012
ApplicantLicense No ASTELLAS PHARMACEUTICALS US INC 1748
Trade Name AMEVIVE
Proper Name ALEFACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125036 0 1 1302003 75 MGVIAL ( 75 MGVIAL ) 09242008
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
125036 0 2 1302003 15 MGVIAL ( 15 MGVIAL ) 09282012
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No BOEHRINGER INGELHEIM PHARMA KG 1251
Trade Name VERLUMA
Proper Name NOFETUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103769 0 1 10131998 10 MGML ( 10 MGML ) 08132013
INTRAVENOUS
March 2018 Page 2 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No CENTOCOR ORTHO BIOTECH PRODUCTS LP 1824
Trade Name ORTHOCLONE OKT3
Proper Name MUROMONAB-CD3
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103463 0 1 9141992 1 MGML ( 1 MGML ) 01112012
SOLUTION INTRAVENOUS AMPULE
ApplicantLicense No EISAI INCORPORATED 1862
Trade Name ONTAK
Proper Name DENILEUKIN DIFTITOX
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103767 0 1 251999 300 MCG2 ML ( 150 MCGML ) 01302014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No ELI LILLY AND CO 1611
Trade Name XIGRIS
Proper Name DROTRECOGIN ALFA (ACTIVATED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125029 0 1 11212001 5 MGVIAL ( 5 MGVIAL ) 10262011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125029 0 2 11212001 20 MGVIAL ( 20 MGVIAL ) 10102011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GENENTECH INC 1048
Trade Name RAPTIVA
Proper Name EFALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125075 0 1 10272003 125 MGVIAL ( 125 MGVIAL ) 09012009
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
March 2018 Page 3 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103976 0 2 6202003 125 MGVIAL ( 125 MGVIAL ) 08252016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103948 0 3 572001 10 MGVIAL ( 10 MGVIAL ) 07062011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name MYOZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125141 0 1 4282006 50 MGVIAL ( 50 MGVIAL ) 10172014
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name BEXXAR THERAPEUTIC REGIME
Proper Name TOSITUMOMAB AND IODINE I-131 TOSITUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125011 0 1 6272003 01 MGML I-131 TOSITUMOMAB ( 01 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 2 6272003 11 MGML I-131 TOSITUMOMAB ( 11 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 3 6272003 14 MGML TOSITUMOMAB ( 14 MGML 03102014 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 4 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No HEMISPHERX BIOPHARMA INC 1703
Trade Name ALFERON N INJECTION
Proper Name INTERFERON ALFA-N3 (HUMAN LEUKOCYTE DERIVED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103158 0 1 10101989 5 MIUVIAL ( 5 MIUVIAL ) 06272013
SOLUTION INTRALESIONAL MULTI-DOSE VIAL
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name ROFERON A
Proper Name INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103145 0 1 641986 3 MIU05 ML ( 3 MIU05 ML ) 06012009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name ZENAPAX
Proper Name DACLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103749 0 1 12101997 25 MG5 ML ( 25 MG5 ML ) 07072011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No KADMON PHARMACEUTICALS LLC 1867
Trade Name INFERGEN
Proper Name INTERFERON ALFACON-1
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103663 0 1 1061997 9 MCG03 ML ( 30 MCGML ) 07252013
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 5 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103770 0 3 6191998 50 MGVIAL ( 50 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
103770 0 4 6191998 100 MGVIAL ( 100 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name INTRON A
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103132 0 6 641986 10 MIUML ( 10 MIUML ) 09232013
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103132 0 7 641986 225 MIU15 ML ( 225 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 8 641986 375 MIU15 ML ( 375 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 9 641986 75 MIU15 ML ( 75 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103949 0 5 1192001 675 MCGPEN ( 675 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 6 1192001 108 MCGPEN ( 108 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
March 2018 Page 6 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name PEGINTRON
103949 0 7 1192001 1184 MCGVIAL ( 1184 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 8 1192001 162 MCGPEN ( 162 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 9 1192001 1776 MCGVIAL ( 1776 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 10 1192001 2025 MCGPEN ( 2025 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 11 1192001 222 MCGVIAL ( 222 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No PALATIN TECHNOLOGIES INC 1588
Trade Name NEUTROSPEC TECHNETIUM (99M TC)
Proper Name FANOLESOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103928 0 1 722004 025 MGVIAL ( 025 MGVIAL ) 09222008
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No RECORDATI RARE DISEASES INC 1899
Trade Name ELSPAR
Proper Name ASPARAGINASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
101063 0 1 1101978 10000 IU ( 10000 IUVIAL ) 04092014
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
March 2018 Page 7 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No SCHERING CORP 0994
Trade Name PEGINTRONREBETOL COMBO PACK
Proper Name PEGINTERFERON ALFA-2B AND RIBAVIRIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125196 0 1 6132008 ( 4 (120 MCG05ML) REDIPEN amp 140 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 2 6132008 ( 4 (150 MCG05ML) REDIPEN amp 168 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 3 6132008 ( 4 (150 MCG05ML) REDIPEN amp 196 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 4 6132008 ( 4 (50 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 5 6132008 ( 4 (80 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125422 0 2 10172012 05 MG ( 25 MGML ) 08082017
SOLUTION INTRAVETREAL SINGLE-DOSE VIAL
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125164 0 10 11142007 50 MCGML ( 50 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 8 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
125164 0 11 11142007 100 MCGML ( 100 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 12 11142007 200 MCGML ( 200 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 13 11142007 300 MCGML ( 300 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 14 11142007 400 MCGML ( 400 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 15 11142007 400 MCG06 ML ( 400 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 16 11142007 600 MCGML ( 600 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 17 11142007 600 MCG06 ML ( 600 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 18 11142007 800 MCG06 ML ( 800 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 19 11142007 1000 MCGML ( 1000 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 9 of 9
CDER Billable Biologic Product List
ApplicantLicense No BRISTOL MYERS SQUIBB CO 1713
Trade Name EMPLICITI
Proper Name ELOTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761035 0 1 11302015
POWDER INTRAVENOUS SINGLE-DOSE VIAL
300 MG ( 300 MGVIAL )
761035 0 2 11302015
POWDER INTRAVENOUS SINGLE-DOSE VIAL
400 MG ( 400 MGVIAL )
Trade Name
Proper Name
BLASTN
125288 0
NULOJIX
BELATACEPT
Approval Date Product
6152011 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
250 MG ( 250 MGVIAL )
Trade Name
Proper Name
BLASTN
125554 0
OPDIVO
NIVOLUMAB
Approval Date Product
12222014 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
40 MG4 ML ( 10 MGML )
125554 0 2 12222014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG10 ML ( 10 MGML )
125554 0 3 12222014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
240 MG24 ML ( 10 MGML )
Trade Name
Proper Name
BLASTN
125118 0
ORENCIA
ABATACEPT
Approval Date Product
12232005 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
250 MG ( 250 MGVIAL )
March 2018 Page 13 of 42
CDER Billable Biologic Product List
ApplicantLicense No BRISTOL MYERS SQUIBB CO 1713
125118 122 2 7292011 50 MG04 ML ( 125 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125118 122 3 7292011 875 MG07 ML ( 125 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125118 122 4 7292011 125 MGML ( 125 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125118 122 5 7292011 125 MGML ( 125 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name YERVOY
Proper Name IPILIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125377 0 1 3252011 50 MG10 ML ( 5 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125377 0 2 3252011 200 MG40 ML ( 5 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No BTG INTERNATIONAL INC 1861
Trade Name VORAXAZE
Proper Name GLUCARPIDASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125327 0 1 1172012 1000 U ( 1000 UVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 14 of 42
CDER Billable Biologic Product List
ApplicantLicense No DYAX CORPORATION 1789
Trade Name KALBITOR
Proper Name ECALLANTIDE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125277 0 1 1212009 10 MGML ( 10 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No EKR THERAPEUTICS INC 1814
Trade Name RETAVASE
Proper Name RETEPLASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103786 0 1 561998 10 U ( 10 UVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No ELI LILLY AND CO 1891
Trade Name CYRAMZA
Proper Name RAMUCIRUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125477 0 1 4212014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG10 ML ( 10 MGML )
125477 0 2 4212014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
500 MG50 ML ( 10 MGML )
Trade Name
Proper Name
BLASTN
761038 0
LARTRUVO
OLARATUMAB
Approval Date Product
10192016 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
500 MG50 ML ( 10 MGML )
761038 0 2 10192016
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
190 MG19 ML ( 10 MGML )
March 2018 Page 15 of 42
CDER Billable Biologic Product List
ApplicantLicense No ELI LILLY AND CO 1891
Trade Name PORTRAZZA
Proper Name NECITUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125547 0 1 11242015
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
800 MG50 ML ( 16 MGML )
Trade Name
Proper Name
TALTZ
IXEKIZUMAB
BLASTN
125521 0
Product
1
Approval Date
3222016
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
80 MGML ( 80 MGML )
125521 0 2 3222016
SOLUTION SUBCUTANEOUS AUTOINJECTOR
80 MGML ( 80 MGML )
Trade Name
Proper Name
TRULICITY
DULAGLUTIDE
BLASTN
125469 0
Product
1
Approval Date
9182014
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
075 MG05 ML ( 075 MG05 ML )
125469 0 2 9182014
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
15 MG05 ML ( 15 MG05 ML )
125469 0 3 9182014
SOLUTION SUBCUTANEOUS AUTOINJECTOR
075 MG05 ML ( 075 MG05 ML )
125469 0 4 9182014
SOLUTION SUBCUTANEOUS AUTOINJECTOR
15 MG05 ML ( 15 MG05 ML )
March 2018 Page 16 of 42
CDER Billable Biologic Product List
ApplicantLicense No ELUSYS THERAPEUTICS INC 1907
Trade Name ANTHIM
Proper Name OBILTOXAXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125509 1 1 3182016 600 MG6 ML ( 100 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No EMD SERONO INC 1773
Trade Name BAVENCIO
Proper Name AVELUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761049 0 1 3232017
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
200 MG10 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
103780 0
REBIF
INTERFERON BETA 1A
Approval Date Product
372002 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
88 MCG02 ML ( 44 MCGML )
103780 0 2 372002
SOLUTION SUBCUTANEOUS AUTOINJECTOR
88 MCG02 ML ( 44 MCGML )
103780 0 3 372002
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
22 MCG05 ML ( 44 MCGML )
103780 0 4 372002
SOLUTION SUBCUTANEOUS AUTOINJECTOR
22 MCG05 ML ( 44 MCGML )
103780 0 5 372002
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
44 MCG05 ML ( 88 MCGML )
103780 0 6 372002
SOLUTION SUBCUTANEOUS AUTOINJECTOR
44 MCG05 ML ( 88 MCGML )
March 2018 Page 17 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name ACTEMRA
Proper Name TOCILIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125276 0 1 182010
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
80 MG4 ML ( 20 MGML )
125276 0 2 182010
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
200 MG10 ML ( 20 MGML )
125276 0 3 182010
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
400 MG20 ML ( 20 MGML )
BLASTN
125472 1
Product
1
Approval Date
10212013
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
162 MG09 ML ( 179 MGML )
Trade Name
Proper Name
BLASTN
103172 0
ACTIVASE
ALTEPLASE
Approval Date Product
11131987 2
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
50 MG ( 50 MGVIAL )
103172 0 3 11131987
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
BLASTN
125085 0
AVASTIN
BEVACIZUMAB
Approval Date Product
2262004 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG4 ML ( 25 MGML )
125085 0 2 2262004
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
400 MG16 ML ( 25 MGML )
March 2018 Page 18 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name CATHFLO ACTIVASE
Proper Name ALTEPLASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103172 0 1 11131987
POWDER INTRACATHETER SINGLE-DOSE VIAL
2 MG ( 2 MGVIAL )
Trade Name
Proper Name
BLASTN
125486 0
GAZYVA
OBINUYUZUMAB
Approval Date Product
1112013 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1000 MG40 ML ( 25 MGML )
Trade Name
Proper Name
BLASTN
761083 0
HEMLIBRA
EMICIZUMAB-KXWH
Approval Date Product
11162017 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML )
761083 0 2 11162017
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
60 MG04 ML ( 150 MGML )
761083 0 3 11162017
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
105 MG07 ML ( 150 MGML )
761083 0 4 11162017
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
150 MGML ( 150 MGML )
Trade Name
Proper Name
BLASTN
103792 0
HERCEPTIN
TRASTUZUMAB
Approval Date Product
9251998 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS MULTI-DOSE VIAL
420 MG ( 420 MGVIAL )
March 2018 Page 19 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
103792 5336 2 2102017 150 MG ( 150 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name KADCYLA
Proper Name ADO-TRASIUZUMAB EMTANSINE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125427 0 1 2222013
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
125427 0 2 2222013
POWDER INTRAVENOUS SINGLE-DOSE VIAL
160 MG ( 160 MGVIAL )
Trade Name
Proper Name
LUCENTIS
RANIBIZUMAB
BLASTN
125156 0
Product
1
Approval Date
6302006
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE
05 MG005 ML ( 10 MGML )
Proper Name RANIDIZUMAB
BLASTN
125156 076
Product
2
Approval Date
8102012
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE
03 MG005 ML ( 6 MGML )
Trade Name
Proper Name
OCREVUS
OCRELIZUMAB
BLASTN
761053 0
Product
1
Approval Date
3282017
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
300 MG10 ML ( 30 MGML )
Trade Name
Proper Name
PERJETA
PERTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 20 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
125409 0 1 682012 420 MG14 ML ( 30 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name PULMOZYME
Proper Name DORNASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103532 0 1 12301993 25 MG25 ML ( 1 MGML )
SOLUTION INHALATION AMPULE
Trade Name RITUXAN
Proper Name RITUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103705 0 1 11261997 100 MG10 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
103705 0 2 11261997 500 MG50 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name RITUXAN HYCELA
Proper Name RITUXIMAB AND HYALURONIDASE HUMAN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761064 0 1 6222017 1400 MG AND 23400 U117 ML ( 11966 MG AND 2000 UML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
761064 0 2 6222017 1600 MG AND 26800 U134 ML ( 11966 MG AND 2000 UML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name TECENTRIQ
Proper Name ATEZOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761034 0 1 582016 1200 MG20 ML ( 60 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name TNKASE
March 2018 Page 21 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Proper Name TENECTEPLASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103909 0 1 622000 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103976 0 1 6202003 150 MG ( 150 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103948 0 1 572001
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML )
Trade Name
Proper Name
FABRAZYME
AGALSIDASE BETA
BLASTN
103979 0
Product
1
Approval Date
4242003
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
5 MG ( 5 MGVIAL )
103979 0 2 4242003
POWDER INTRAVENOUS SINGLE-DOSE VIAL
35 MG ( 35 MGVIAL )
Trade Name
Proper Name
LEMTRADA
ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 22 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENZYME CORP 1596
103948 5139 2 11142014 12 MG12 ML ( 10MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name LUMIZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125291 0 1 5242010 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name NUCALA
Proper Name MEPOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125526 0 1 11142015
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
TANZEUM
ALBIGLUTIDE
BLASTN
125431 0
Product
1
Approval Date
4152014
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS AUTOINJECTOR
30 MG ( 30 MGAUTOINJECTOR )
125431 0 2 4152014
POWDER SUBCUTANEOUS AUTOINJECTOR
50 MG ( 50 MGAUTOINJECTOR )
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name PEGASYS
Proper Name PEGINTERFERON ALFA 2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103964 5204 4 9292011 180 MCG05 ML ( 360 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 23 of 42
CDER Billable Biologic Product List
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Proper Name PEG-INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103964 0 1 10162002 180 MCGML ( 180 MCGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
103964 0 2 10162002 180 MCG05 ML ( 360 MCGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
103964 5204 3 9292011 135 MCG05 ML ( 270 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
ApplicantLicense No HORIZON PHARMA IRELAND LTD 2022
Trade Name ACTIMMUNE
Proper Name INTERFERON GAMMA-1B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103836 0 1 2251999 100 MCG05 ML ( 200 MCGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No HORIZON PHARMA RHEUMATOLOGY LLC 1998
Trade Name KRYSTEXXA
Proper Name PEGLOTICASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125293 0 1 9142010 8MGML ( 8MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 24 of 42
CDER Billable Biologic Product List
ApplicantLicense No HUMAN GENOME SCIENCES INC 1820
Trade Name BENLYSTA
Proper Name BELIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125370 0 1 392011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
120 MG ( 120 MGVIAL )
125370 0 2 392011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
400 MG ( 400 MGVIAL )
125370 0 3 392011
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )
125370 0 4 392011
SOLUTION SUBCUTANEOUS AUTOINJECTOR
200 MGML ( 200 MGML )
BLASTN
761043 0
Product
1
Approval Date
7202017
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )
Trade Name
Proper Name
RAXIBACUMAB
RAXIBACUMAB
BLASTN
125349 0
Product
1
Approval Date
12142012
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1700 MG34 ML ( 50 MGML )
ApplicantLicense No IMCLONE LLC 1695
Trade Name ERBITUX
Proper Name CETUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125084 0 1 2122004 100 MG50 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 25 of 42
CDER Billable Biologic Product List
ApplicantLicense No IMCLONE LLC 1695
125084 0 2 2122004 200 MG100 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No IMMUNEX CORP 1132
Trade Name ENBREL
Proper Name ETANERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103795 0 1 1121998
POWDER SUBCUTANEOUS MULTI-DOSE VIAL
25 MG ( 25 MGVIAL )
103795 5184 2 9272004
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
50 MGML ( 50 MGML )
103795 0 3 9272004
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MGML ( 50 MGML )
103795 5184 4 9272004
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
25 MG05 ML ( 50 MGML )
103795 5556 5 9142017
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MGML ( 50 MGML )
ApplicantLicense No IPSEN BIOPHARM LIMITED 1787
Trade Name DYSPORT
Proper Name ABOBOTULINUMTOXINA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125274 0 1 4292009
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
300 UNITS ( 300 UNITSVIAL )
125274 0 2 4292009
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
500 UNITS ( 500 UNITSVIAL )
March 2018 Page 26 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
Trade Name DARZALEX
Proper Name DARATUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761036 0 1 11162015
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG5 ML ( 20 MGML )
761036 0 2 11162015
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
400 MG20 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
103772 0
REMICADE
INFLIXIMAB
Approval Date Product
8241998 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
BLASTN
103575 0
REOPRO
ABCIXIMAB
Approval Date Product
12221994 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
10 MG5 ML ( 2 MGML )
Trade Name
Proper Name
BLASTN
125289 0
SIMPONI
GOLIMUMAB
Approval Date Product
4242009 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
50 MG05 ML ( 100 MGML )
125289 0 2 4242009
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MG05 ML ( 100 MGML )
125289 0 3 4242009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
100 MGML ( 100 MGML )
March 2018 Page 27 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
125289 0 4 4242009 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name SIMPONI ARIA
Proper Name GOLIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125433 0 1 7182013 50 MG4 ML ( 125 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name STELARA
Proper Name USTEKINUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125261 0 1 9252009 90 MGML ( 90 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125261 0 2 9252009 45 MG05 ML ( 90 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL amp PREFILLED SYRINGE
125261 0 3 9252009 130 MG26 ML ( 5 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761044 0 1 9232016 130 MG26 ML ( 5 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SYLVANT
Proper Name SILTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125496 0 1 4232014 100 MG ( 100 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125496 0 2 4232014 400 MG ( 400 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 28 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
Trade Name TREMFYA
Proper Name GUSELKUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761061 0 1 7132017 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No JAZZ PHARMACEUTICALS INC 1901
Trade Name ERWINAZE
Proper Name ASPARAGINASE ERWINIA CHRYSANTHEMI
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
105359 0 1 11182011 10000 IU ( 10000 IUVIAL )
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103770 0 1 6191998
SOLUTION INTRAMUSCULAR
50 MG05 ML ( 100 MGML )
SINGLE-DOSE VIAL
103770 0 2 6191998
SOLUTION INTRAMUSCULAR
100 MGML ( 100 MGML )
SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name ILUMYA
Proper Name TILDRAKIZUMAB-ASMN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761067 0 1 3202018 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name INTRON A
March 2018 Page 29 of 42
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103132 0 1 641986 10 MIU ( 10 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL INTRAVENOUS SINGLE-DOSE VIAL
103132 0 2 641986 18 MIU ( 18 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL
103132 0 3 641986 50 MIU ( 50 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL
103132 0 4 641986 228 MIU38 ML ( 6 MIUML )
SOLUTION INTRAMUSCULAR SUBCUTANEOUS MULTI-DOSE VIAL
103132 0 5 641986 32 MIU32 ML ( 10 MIUML )
SOLUTION INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL MULTI-DOSE VIAL
Trade Name KEYTRUDA
Proper Name PEMBROLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125514 0 1 942014 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125514 1 2 1152015 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 0 1 1192001 74 MCG ( 74 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SYLATRON
Proper Name PEGINTERFERON ALFA-2B
March 2018 Page 30 of 42
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 5153 2 3292011 296 MCG ( 296 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 3 3292011 444 MCG ( 444 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 4 3292011 888 MCG ( 888 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name ZINPLAVA
Proper Name BEZLOTOXUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761046 0 1 10212016 1000 MG40 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No MERZ PHARMACEUTICALS GMBH 1830
Trade Name XEOMIN
Proper Name INCOBOTULINUMTOXINA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125360 0 1 7302010
POWDER INTRAMUSCULAR
50 U ( 50 UVIAL )
SINGLE-DOSE VIAL
125360 0 2 7302010
POWDER INTRAMUSCULAR
100 U ( 100 UVIAL )
SINGLE-DOSE VIAL
125360 3 3 11202015
POWDER INTRAMUSCULAR
200 U ( 200 UVIAL )
SINGLE-DOSE VIAL
March 2018 Page 31 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
Trade Name ARZERRA
Proper Name OFATUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125326 0 1 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG5 ML ( 20 MGML )
125326 0 2 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1000 MG50 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
125504 0
COSENTYX
SECUKINUMAB
Approval Date Product
1212015 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
150 MG ( 150 MGVIAL )
125504 0 2 1212015
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MGML ( 150 MGML )
125504 0 3 1212015
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MGML ( 150 MGML )
Trade Name
Proper Name
BLASTN
125290 0
EXTAVIA
INTERFERON BETA-1B
Approval Date Product
8142009 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
03 MG ( 03 MGVIAL )
Trade Name
Proper Name
BLASTN
125319 0
ILARIS
CANAKINUMAB
Approval Date Product
6172009 1
PotencyDosage FormRoutePresentation
180 MGVIAL ( 180 MGVIAL )
March 2018 Page 32 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
125319 88 2 12222016 150 MG ( 150 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
125319 0 3 12222016 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SIMULECT
Proper Name BASILIXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103764 0 1 5121998 10 MG ( 10 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
103764 0 2 5121998 20 MG ( 20 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No NPS PHARMACEUTICALS INC 1908
Trade Name NATPARA
Proper Name PARATHYROID HORMONE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 33 of 42
CDER Billable Biologic Product List
ApplicantLicense No PROMETHEUS LABORATORIES INC 1848
Trade Name PROLEUKIN
Proper Name ALDESLEUKIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103293 0 1 551992 22 MIU ( 22 MIUVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760
Trade Name ARCALYST
Proper Name RILONACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125249 0 1 2272008
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
220MG ( 220MGVIAL )
Trade Name
Proper Name
DUPIXENT
DUPILUMAB
BLASTN
761055 0
Product
1
Approval Date
3282017
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
300 MG2 ML ( 150 MGML )
Trade Name
Proper Name
EYLEA
AFLIBERCEPT
BLASTN
125387 0
Product
1
Approval Date
11182011
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
2 MG005 ML ( 40 MGML )
March 2018 Page 34 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Trade Name ELITEK
Proper Name RASBURICASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103946 0 1 7122002
POWDER INTRAVENOUS SINGLE-DOSE VIAL
15 MG ( 15 MGVIAL )
103946 5020 2 162006
POWDER INTRAVENOUS SINGLE-DOSE VIAL
75 MG ( 75 MGVIAL )
Trade Name
Proper Name
BLASTN
761037 0
KEVZARA
SARILUMAB
Approval Date Product
5222017 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MG114 ML ( 13158 MGML )
761037 0 2 5222017
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MG114 ML ( 17544 MGML )
761037 1 3 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MG114 ML ( 13158 MGML )
761037 1 4 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
200 MG114 ML ( 17544 MGML )
Trade Name
Proper Name
BLASTN
103362 0
LEUKINE
SARGRAMOSTIM
Approval Date Product
351991 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
250 MCG ( 250 MCGVIAL )
103362 0 2 351991
SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL
500 MCGML ( 500 MCGML )
Trade Name PRALUENT
March 2018 Page 35 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Proper Name ALIROCUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125559 0 1 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 2 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 3 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125559 0 4 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name ZALTRAP
Proper Name ZIV-AFLIBERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125418 0 1 832012 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125418 0 2 832012 200 MG8 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SEATTLE GENETICS INC 1853
Trade Name ADCETRIS
Proper Name BRENTUXIMAB VEDOTIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125388 1 1 8192011 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 36 of 42
CDER Billable Biologic Product List
ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593
Trade Name ELAPRASE
Proper Name IDURSULFASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125151 0 1 7242006 6 MG3 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SICOR BIOTECH UAB 1803
Trade Name GRANIX
Proper Name TBO-FILGRASTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125294 0 1 8292012
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
300 MCG0 5 ML ( 600 MCGML )
125294 0 2 8292012
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
480 MCG08 ML ( 600 MCGML )
ApplicantLicense No SMITH AND NEPHEW INC 2004
Trade Name REGRANEX
Proper Name BECAPLERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103691 0 1 12161997
GEL TOPICAL
100 UG ( 100 UGGM )
Trade Name
Proper Name
SANTYL
COLLAGENASE
BLASTN
101995 0
Product
1
Approval Date
641965
PotencyDosage FormRoutePresentation
OINTMENT TOPICAL
30 G amp 90 G TUBE ( 250 UGRAM )
March 2018 Page 37 of 42
CDER Billable Biologic Product List
ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718
Trade Name MYOBLOC
Proper Name RIMABOTULINUM TOXIN B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103846 0 1 1282002
SOLUTION INTRAMUSCULAR
2500 IU05 ML ( 5000 IUML )
SINGLE-DOSE VIAL
103846 0 3 1282002
SOLUTION INTRAMUSCULAR
10000 IU2 ML ( 5000 IUML )
SINGLE-DOSE VIAL
Proper Name RIMABOTULINUMTOXINB
BLASTN
103846 0
Product
2
Approval Date
1282002
PotencyDosage FormRoutePresentation
SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL
5000 IUML ( 5000 IUML )
ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832
Trade Name ZEVALIN
Proper Name IBRITUMOMAB TIUXETAN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125019 0 1 2192002 32 MG2 ML ( 16 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
Trade Name KEPIVANCE
Proper Name PALIFERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125103 0 1 12152004 625 MG ( 625 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name KINERET
Proper Name ANAKINRA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 38 of 42
CDER Billable Biologic Product List
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898
Trade Name ENTYVIO
Proper Name VEDOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125476 0 1 5202014 300 MG ( 300 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No TEVA RESPIRATORY LLC 2047
Trade Name CINQAIR
Proper Name RESLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761033 0 1 3232016 100 MG10 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No THERATECHNOLOGIES INC 2091
Trade Name TROGARZO
Proper Name IBALIZUMAB-UIYK
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761065 0 1 362018 200 MG133 ML ( 150 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 39 of 42
CDER Billable Biologic Product List
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
0375 MG03 ML ( 125 MGML )2222017 125422 038 1
ApplicantLicense No UCB INC 1736
Trade Name CIMZIA
Proper Name CERTOLIZUMAB PEGOL
BLASTN Approval Date PotencyDosage FormRoutePresentation Product
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
200 MG ( 200 MGVIAL ) 4222008 125160 0 1
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )5132009 125160 080 2
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
Trade Name CRYSVITA
Proper Name BUROSUMAB-TWZA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761068 0 1 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
10 MGML ( 10 MGML )
761068 0 2 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
20 MGML ( 20 MGML )
761068 0
Trade Name
Proper Name
BLASTN
March 2018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML ) 4172018 3
MEPSEVII
VESTRONIDASE ALFA-VJBK
Approval Date PotencyDosage FormRoutePresentation Product
Page 40 of 42
CDER Billable Biologic Product List
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
761047 0 1 11152017 10 MG5 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No UNITED THERAPEUTICS CORP 1993
Trade Name UNITUXIN
Proper Name DINUTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125516 0 1 3102015 175 MG5 ML ( 35 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053
Trade Name SILIQ
Proper Name BRODALUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761032 0 1 2152017 210 MG15 ML ( 140 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 41 of 42
CDER Billable Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No WYETH PHARMACEUTICALS INC 0003
Trade Name BESPONSA
Proper Name INOTUZUMAB OZOGAMICIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761040 0 1 8172017 09 MG ( 09 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 42 of 42
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 1 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
9172001 103951 0 26
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
200 MCGML ( 200 MCGML ) 09272012
103951 0 27 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
200 MCG04 ML ( 500 MCGML ) 09272012
103951 0 28 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
300 MCGML ( 300 MCGML ) 09272012
103951 0 29 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
300 MCG06 ML ( 500 MCGML ) 09272012
103951 0 30 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
500 MCGML ( 500 MCGML ) 09272012
ApplicantLicense No ASTELLAS PHARMACEUTICALS US INC 1748
Trade Name AMEVIVE
Proper Name ALEFACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125036 0 1 1302003 75 MGVIAL ( 75 MGVIAL ) 09242008
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
125036 0 2 1302003 15 MGVIAL ( 15 MGVIAL ) 09282012
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No BOEHRINGER INGELHEIM PHARMA KG 1251
Trade Name VERLUMA
Proper Name NOFETUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103769 0 1 10131998 10 MGML ( 10 MGML ) 08132013
INTRAVENOUS
March 2018 Page 2 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No CENTOCOR ORTHO BIOTECH PRODUCTS LP 1824
Trade Name ORTHOCLONE OKT3
Proper Name MUROMONAB-CD3
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103463 0 1 9141992 1 MGML ( 1 MGML ) 01112012
SOLUTION INTRAVENOUS AMPULE
ApplicantLicense No EISAI INCORPORATED 1862
Trade Name ONTAK
Proper Name DENILEUKIN DIFTITOX
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103767 0 1 251999 300 MCG2 ML ( 150 MCGML ) 01302014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No ELI LILLY AND CO 1611
Trade Name XIGRIS
Proper Name DROTRECOGIN ALFA (ACTIVATED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125029 0 1 11212001 5 MGVIAL ( 5 MGVIAL ) 10262011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125029 0 2 11212001 20 MGVIAL ( 20 MGVIAL ) 10102011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GENENTECH INC 1048
Trade Name RAPTIVA
Proper Name EFALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125075 0 1 10272003 125 MGVIAL ( 125 MGVIAL ) 09012009
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
March 2018 Page 3 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103976 0 2 6202003 125 MGVIAL ( 125 MGVIAL ) 08252016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103948 0 3 572001 10 MGVIAL ( 10 MGVIAL ) 07062011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name MYOZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125141 0 1 4282006 50 MGVIAL ( 50 MGVIAL ) 10172014
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name BEXXAR THERAPEUTIC REGIME
Proper Name TOSITUMOMAB AND IODINE I-131 TOSITUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125011 0 1 6272003 01 MGML I-131 TOSITUMOMAB ( 01 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 2 6272003 11 MGML I-131 TOSITUMOMAB ( 11 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 3 6272003 14 MGML TOSITUMOMAB ( 14 MGML 03102014 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 4 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No HEMISPHERX BIOPHARMA INC 1703
Trade Name ALFERON N INJECTION
Proper Name INTERFERON ALFA-N3 (HUMAN LEUKOCYTE DERIVED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103158 0 1 10101989 5 MIUVIAL ( 5 MIUVIAL ) 06272013
SOLUTION INTRALESIONAL MULTI-DOSE VIAL
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name ROFERON A
Proper Name INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103145 0 1 641986 3 MIU05 ML ( 3 MIU05 ML ) 06012009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name ZENAPAX
Proper Name DACLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103749 0 1 12101997 25 MG5 ML ( 25 MG5 ML ) 07072011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No KADMON PHARMACEUTICALS LLC 1867
Trade Name INFERGEN
Proper Name INTERFERON ALFACON-1
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103663 0 1 1061997 9 MCG03 ML ( 30 MCGML ) 07252013
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 5 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103770 0 3 6191998 50 MGVIAL ( 50 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
103770 0 4 6191998 100 MGVIAL ( 100 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name INTRON A
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103132 0 6 641986 10 MIUML ( 10 MIUML ) 09232013
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103132 0 7 641986 225 MIU15 ML ( 225 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 8 641986 375 MIU15 ML ( 375 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 9 641986 75 MIU15 ML ( 75 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103949 0 5 1192001 675 MCGPEN ( 675 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 6 1192001 108 MCGPEN ( 108 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
March 2018 Page 6 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name PEGINTRON
103949 0 7 1192001 1184 MCGVIAL ( 1184 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 8 1192001 162 MCGPEN ( 162 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 9 1192001 1776 MCGVIAL ( 1776 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 10 1192001 2025 MCGPEN ( 2025 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 11 1192001 222 MCGVIAL ( 222 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No PALATIN TECHNOLOGIES INC 1588
Trade Name NEUTROSPEC TECHNETIUM (99M TC)
Proper Name FANOLESOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103928 0 1 722004 025 MGVIAL ( 025 MGVIAL ) 09222008
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No RECORDATI RARE DISEASES INC 1899
Trade Name ELSPAR
Proper Name ASPARAGINASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
101063 0 1 1101978 10000 IU ( 10000 IUVIAL ) 04092014
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
March 2018 Page 7 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No SCHERING CORP 0994
Trade Name PEGINTRONREBETOL COMBO PACK
Proper Name PEGINTERFERON ALFA-2B AND RIBAVIRIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125196 0 1 6132008 ( 4 (120 MCG05ML) REDIPEN amp 140 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 2 6132008 ( 4 (150 MCG05ML) REDIPEN amp 168 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 3 6132008 ( 4 (150 MCG05ML) REDIPEN amp 196 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 4 6132008 ( 4 (50 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 5 6132008 ( 4 (80 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125422 0 2 10172012 05 MG ( 25 MGML ) 08082017
SOLUTION INTRAVETREAL SINGLE-DOSE VIAL
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125164 0 10 11142007 50 MCGML ( 50 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 8 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
125164 0 11 11142007 100 MCGML ( 100 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 12 11142007 200 MCGML ( 200 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 13 11142007 300 MCGML ( 300 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 14 11142007 400 MCGML ( 400 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 15 11142007 400 MCG06 ML ( 400 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 16 11142007 600 MCGML ( 600 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 17 11142007 600 MCG06 ML ( 600 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 18 11142007 800 MCG06 ML ( 800 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 19 11142007 1000 MCGML ( 1000 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 9 of 9
CDER Billable Biologic Product List
ApplicantLicense No BRISTOL MYERS SQUIBB CO 1713
125118 122 2 7292011 50 MG04 ML ( 125 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125118 122 3 7292011 875 MG07 ML ( 125 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125118 122 4 7292011 125 MGML ( 125 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125118 122 5 7292011 125 MGML ( 125 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name YERVOY
Proper Name IPILIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125377 0 1 3252011 50 MG10 ML ( 5 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125377 0 2 3252011 200 MG40 ML ( 5 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No BTG INTERNATIONAL INC 1861
Trade Name VORAXAZE
Proper Name GLUCARPIDASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125327 0 1 1172012 1000 U ( 1000 UVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 14 of 42
CDER Billable Biologic Product List
ApplicantLicense No DYAX CORPORATION 1789
Trade Name KALBITOR
Proper Name ECALLANTIDE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125277 0 1 1212009 10 MGML ( 10 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No EKR THERAPEUTICS INC 1814
Trade Name RETAVASE
Proper Name RETEPLASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103786 0 1 561998 10 U ( 10 UVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No ELI LILLY AND CO 1891
Trade Name CYRAMZA
Proper Name RAMUCIRUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125477 0 1 4212014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG10 ML ( 10 MGML )
125477 0 2 4212014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
500 MG50 ML ( 10 MGML )
Trade Name
Proper Name
BLASTN
761038 0
LARTRUVO
OLARATUMAB
Approval Date Product
10192016 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
500 MG50 ML ( 10 MGML )
761038 0 2 10192016
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
190 MG19 ML ( 10 MGML )
March 2018 Page 15 of 42
CDER Billable Biologic Product List
ApplicantLicense No ELI LILLY AND CO 1891
Trade Name PORTRAZZA
Proper Name NECITUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125547 0 1 11242015
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
800 MG50 ML ( 16 MGML )
Trade Name
Proper Name
TALTZ
IXEKIZUMAB
BLASTN
125521 0
Product
1
Approval Date
3222016
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
80 MGML ( 80 MGML )
125521 0 2 3222016
SOLUTION SUBCUTANEOUS AUTOINJECTOR
80 MGML ( 80 MGML )
Trade Name
Proper Name
TRULICITY
DULAGLUTIDE
BLASTN
125469 0
Product
1
Approval Date
9182014
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
075 MG05 ML ( 075 MG05 ML )
125469 0 2 9182014
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
15 MG05 ML ( 15 MG05 ML )
125469 0 3 9182014
SOLUTION SUBCUTANEOUS AUTOINJECTOR
075 MG05 ML ( 075 MG05 ML )
125469 0 4 9182014
SOLUTION SUBCUTANEOUS AUTOINJECTOR
15 MG05 ML ( 15 MG05 ML )
March 2018 Page 16 of 42
CDER Billable Biologic Product List
ApplicantLicense No ELUSYS THERAPEUTICS INC 1907
Trade Name ANTHIM
Proper Name OBILTOXAXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125509 1 1 3182016 600 MG6 ML ( 100 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No EMD SERONO INC 1773
Trade Name BAVENCIO
Proper Name AVELUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761049 0 1 3232017
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
200 MG10 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
103780 0
REBIF
INTERFERON BETA 1A
Approval Date Product
372002 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
88 MCG02 ML ( 44 MCGML )
103780 0 2 372002
SOLUTION SUBCUTANEOUS AUTOINJECTOR
88 MCG02 ML ( 44 MCGML )
103780 0 3 372002
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
22 MCG05 ML ( 44 MCGML )
103780 0 4 372002
SOLUTION SUBCUTANEOUS AUTOINJECTOR
22 MCG05 ML ( 44 MCGML )
103780 0 5 372002
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
44 MCG05 ML ( 88 MCGML )
103780 0 6 372002
SOLUTION SUBCUTANEOUS AUTOINJECTOR
44 MCG05 ML ( 88 MCGML )
March 2018 Page 17 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name ACTEMRA
Proper Name TOCILIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125276 0 1 182010
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
80 MG4 ML ( 20 MGML )
125276 0 2 182010
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
200 MG10 ML ( 20 MGML )
125276 0 3 182010
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
400 MG20 ML ( 20 MGML )
BLASTN
125472 1
Product
1
Approval Date
10212013
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
162 MG09 ML ( 179 MGML )
Trade Name
Proper Name
BLASTN
103172 0
ACTIVASE
ALTEPLASE
Approval Date Product
11131987 2
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
50 MG ( 50 MGVIAL )
103172 0 3 11131987
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
BLASTN
125085 0
AVASTIN
BEVACIZUMAB
Approval Date Product
2262004 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG4 ML ( 25 MGML )
125085 0 2 2262004
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
400 MG16 ML ( 25 MGML )
March 2018 Page 18 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name CATHFLO ACTIVASE
Proper Name ALTEPLASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103172 0 1 11131987
POWDER INTRACATHETER SINGLE-DOSE VIAL
2 MG ( 2 MGVIAL )
Trade Name
Proper Name
BLASTN
125486 0
GAZYVA
OBINUYUZUMAB
Approval Date Product
1112013 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1000 MG40 ML ( 25 MGML )
Trade Name
Proper Name
BLASTN
761083 0
HEMLIBRA
EMICIZUMAB-KXWH
Approval Date Product
11162017 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML )
761083 0 2 11162017
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
60 MG04 ML ( 150 MGML )
761083 0 3 11162017
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
105 MG07 ML ( 150 MGML )
761083 0 4 11162017
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
150 MGML ( 150 MGML )
Trade Name
Proper Name
BLASTN
103792 0
HERCEPTIN
TRASTUZUMAB
Approval Date Product
9251998 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS MULTI-DOSE VIAL
420 MG ( 420 MGVIAL )
March 2018 Page 19 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
103792 5336 2 2102017 150 MG ( 150 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name KADCYLA
Proper Name ADO-TRASIUZUMAB EMTANSINE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125427 0 1 2222013
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
125427 0 2 2222013
POWDER INTRAVENOUS SINGLE-DOSE VIAL
160 MG ( 160 MGVIAL )
Trade Name
Proper Name
LUCENTIS
RANIBIZUMAB
BLASTN
125156 0
Product
1
Approval Date
6302006
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE
05 MG005 ML ( 10 MGML )
Proper Name RANIDIZUMAB
BLASTN
125156 076
Product
2
Approval Date
8102012
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE
03 MG005 ML ( 6 MGML )
Trade Name
Proper Name
OCREVUS
OCRELIZUMAB
BLASTN
761053 0
Product
1
Approval Date
3282017
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
300 MG10 ML ( 30 MGML )
Trade Name
Proper Name
PERJETA
PERTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 20 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
125409 0 1 682012 420 MG14 ML ( 30 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name PULMOZYME
Proper Name DORNASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103532 0 1 12301993 25 MG25 ML ( 1 MGML )
SOLUTION INHALATION AMPULE
Trade Name RITUXAN
Proper Name RITUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103705 0 1 11261997 100 MG10 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
103705 0 2 11261997 500 MG50 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name RITUXAN HYCELA
Proper Name RITUXIMAB AND HYALURONIDASE HUMAN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761064 0 1 6222017 1400 MG AND 23400 U117 ML ( 11966 MG AND 2000 UML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
761064 0 2 6222017 1600 MG AND 26800 U134 ML ( 11966 MG AND 2000 UML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name TECENTRIQ
Proper Name ATEZOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761034 0 1 582016 1200 MG20 ML ( 60 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name TNKASE
March 2018 Page 21 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Proper Name TENECTEPLASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103909 0 1 622000 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103976 0 1 6202003 150 MG ( 150 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103948 0 1 572001
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML )
Trade Name
Proper Name
FABRAZYME
AGALSIDASE BETA
BLASTN
103979 0
Product
1
Approval Date
4242003
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
5 MG ( 5 MGVIAL )
103979 0 2 4242003
POWDER INTRAVENOUS SINGLE-DOSE VIAL
35 MG ( 35 MGVIAL )
Trade Name
Proper Name
LEMTRADA
ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 22 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENZYME CORP 1596
103948 5139 2 11142014 12 MG12 ML ( 10MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name LUMIZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125291 0 1 5242010 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name NUCALA
Proper Name MEPOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125526 0 1 11142015
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
TANZEUM
ALBIGLUTIDE
BLASTN
125431 0
Product
1
Approval Date
4152014
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS AUTOINJECTOR
30 MG ( 30 MGAUTOINJECTOR )
125431 0 2 4152014
POWDER SUBCUTANEOUS AUTOINJECTOR
50 MG ( 50 MGAUTOINJECTOR )
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name PEGASYS
Proper Name PEGINTERFERON ALFA 2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103964 5204 4 9292011 180 MCG05 ML ( 360 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 23 of 42
CDER Billable Biologic Product List
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Proper Name PEG-INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103964 0 1 10162002 180 MCGML ( 180 MCGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
103964 0 2 10162002 180 MCG05 ML ( 360 MCGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
103964 5204 3 9292011 135 MCG05 ML ( 270 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
ApplicantLicense No HORIZON PHARMA IRELAND LTD 2022
Trade Name ACTIMMUNE
Proper Name INTERFERON GAMMA-1B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103836 0 1 2251999 100 MCG05 ML ( 200 MCGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No HORIZON PHARMA RHEUMATOLOGY LLC 1998
Trade Name KRYSTEXXA
Proper Name PEGLOTICASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125293 0 1 9142010 8MGML ( 8MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 24 of 42
CDER Billable Biologic Product List
ApplicantLicense No HUMAN GENOME SCIENCES INC 1820
Trade Name BENLYSTA
Proper Name BELIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125370 0 1 392011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
120 MG ( 120 MGVIAL )
125370 0 2 392011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
400 MG ( 400 MGVIAL )
125370 0 3 392011
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )
125370 0 4 392011
SOLUTION SUBCUTANEOUS AUTOINJECTOR
200 MGML ( 200 MGML )
BLASTN
761043 0
Product
1
Approval Date
7202017
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )
Trade Name
Proper Name
RAXIBACUMAB
RAXIBACUMAB
BLASTN
125349 0
Product
1
Approval Date
12142012
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1700 MG34 ML ( 50 MGML )
ApplicantLicense No IMCLONE LLC 1695
Trade Name ERBITUX
Proper Name CETUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125084 0 1 2122004 100 MG50 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 25 of 42
CDER Billable Biologic Product List
ApplicantLicense No IMCLONE LLC 1695
125084 0 2 2122004 200 MG100 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No IMMUNEX CORP 1132
Trade Name ENBREL
Proper Name ETANERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103795 0 1 1121998
POWDER SUBCUTANEOUS MULTI-DOSE VIAL
25 MG ( 25 MGVIAL )
103795 5184 2 9272004
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
50 MGML ( 50 MGML )
103795 0 3 9272004
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MGML ( 50 MGML )
103795 5184 4 9272004
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
25 MG05 ML ( 50 MGML )
103795 5556 5 9142017
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MGML ( 50 MGML )
ApplicantLicense No IPSEN BIOPHARM LIMITED 1787
Trade Name DYSPORT
Proper Name ABOBOTULINUMTOXINA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125274 0 1 4292009
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
300 UNITS ( 300 UNITSVIAL )
125274 0 2 4292009
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
500 UNITS ( 500 UNITSVIAL )
March 2018 Page 26 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
Trade Name DARZALEX
Proper Name DARATUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761036 0 1 11162015
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG5 ML ( 20 MGML )
761036 0 2 11162015
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
400 MG20 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
103772 0
REMICADE
INFLIXIMAB
Approval Date Product
8241998 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
BLASTN
103575 0
REOPRO
ABCIXIMAB
Approval Date Product
12221994 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
10 MG5 ML ( 2 MGML )
Trade Name
Proper Name
BLASTN
125289 0
SIMPONI
GOLIMUMAB
Approval Date Product
4242009 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
50 MG05 ML ( 100 MGML )
125289 0 2 4242009
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MG05 ML ( 100 MGML )
125289 0 3 4242009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
100 MGML ( 100 MGML )
March 2018 Page 27 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
125289 0 4 4242009 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name SIMPONI ARIA
Proper Name GOLIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125433 0 1 7182013 50 MG4 ML ( 125 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name STELARA
Proper Name USTEKINUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125261 0 1 9252009 90 MGML ( 90 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125261 0 2 9252009 45 MG05 ML ( 90 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL amp PREFILLED SYRINGE
125261 0 3 9252009 130 MG26 ML ( 5 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761044 0 1 9232016 130 MG26 ML ( 5 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SYLVANT
Proper Name SILTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125496 0 1 4232014 100 MG ( 100 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125496 0 2 4232014 400 MG ( 400 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 28 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
Trade Name TREMFYA
Proper Name GUSELKUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761061 0 1 7132017 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No JAZZ PHARMACEUTICALS INC 1901
Trade Name ERWINAZE
Proper Name ASPARAGINASE ERWINIA CHRYSANTHEMI
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
105359 0 1 11182011 10000 IU ( 10000 IUVIAL )
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103770 0 1 6191998
SOLUTION INTRAMUSCULAR
50 MG05 ML ( 100 MGML )
SINGLE-DOSE VIAL
103770 0 2 6191998
SOLUTION INTRAMUSCULAR
100 MGML ( 100 MGML )
SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name ILUMYA
Proper Name TILDRAKIZUMAB-ASMN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761067 0 1 3202018 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name INTRON A
March 2018 Page 29 of 42
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103132 0 1 641986 10 MIU ( 10 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL INTRAVENOUS SINGLE-DOSE VIAL
103132 0 2 641986 18 MIU ( 18 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL
103132 0 3 641986 50 MIU ( 50 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL
103132 0 4 641986 228 MIU38 ML ( 6 MIUML )
SOLUTION INTRAMUSCULAR SUBCUTANEOUS MULTI-DOSE VIAL
103132 0 5 641986 32 MIU32 ML ( 10 MIUML )
SOLUTION INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL MULTI-DOSE VIAL
Trade Name KEYTRUDA
Proper Name PEMBROLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125514 0 1 942014 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125514 1 2 1152015 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 0 1 1192001 74 MCG ( 74 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SYLATRON
Proper Name PEGINTERFERON ALFA-2B
March 2018 Page 30 of 42
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 5153 2 3292011 296 MCG ( 296 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 3 3292011 444 MCG ( 444 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 4 3292011 888 MCG ( 888 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name ZINPLAVA
Proper Name BEZLOTOXUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761046 0 1 10212016 1000 MG40 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No MERZ PHARMACEUTICALS GMBH 1830
Trade Name XEOMIN
Proper Name INCOBOTULINUMTOXINA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125360 0 1 7302010
POWDER INTRAMUSCULAR
50 U ( 50 UVIAL )
SINGLE-DOSE VIAL
125360 0 2 7302010
POWDER INTRAMUSCULAR
100 U ( 100 UVIAL )
SINGLE-DOSE VIAL
125360 3 3 11202015
POWDER INTRAMUSCULAR
200 U ( 200 UVIAL )
SINGLE-DOSE VIAL
March 2018 Page 31 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
Trade Name ARZERRA
Proper Name OFATUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125326 0 1 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG5 ML ( 20 MGML )
125326 0 2 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1000 MG50 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
125504 0
COSENTYX
SECUKINUMAB
Approval Date Product
1212015 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
150 MG ( 150 MGVIAL )
125504 0 2 1212015
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MGML ( 150 MGML )
125504 0 3 1212015
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MGML ( 150 MGML )
Trade Name
Proper Name
BLASTN
125290 0
EXTAVIA
INTERFERON BETA-1B
Approval Date Product
8142009 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
03 MG ( 03 MGVIAL )
Trade Name
Proper Name
BLASTN
125319 0
ILARIS
CANAKINUMAB
Approval Date Product
6172009 1
PotencyDosage FormRoutePresentation
180 MGVIAL ( 180 MGVIAL )
March 2018 Page 32 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
125319 88 2 12222016 150 MG ( 150 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
125319 0 3 12222016 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SIMULECT
Proper Name BASILIXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103764 0 1 5121998 10 MG ( 10 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
103764 0 2 5121998 20 MG ( 20 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No NPS PHARMACEUTICALS INC 1908
Trade Name NATPARA
Proper Name PARATHYROID HORMONE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 33 of 42
CDER Billable Biologic Product List
ApplicantLicense No PROMETHEUS LABORATORIES INC 1848
Trade Name PROLEUKIN
Proper Name ALDESLEUKIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103293 0 1 551992 22 MIU ( 22 MIUVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760
Trade Name ARCALYST
Proper Name RILONACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125249 0 1 2272008
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
220MG ( 220MGVIAL )
Trade Name
Proper Name
DUPIXENT
DUPILUMAB
BLASTN
761055 0
Product
1
Approval Date
3282017
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
300 MG2 ML ( 150 MGML )
Trade Name
Proper Name
EYLEA
AFLIBERCEPT
BLASTN
125387 0
Product
1
Approval Date
11182011
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
2 MG005 ML ( 40 MGML )
March 2018 Page 34 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Trade Name ELITEK
Proper Name RASBURICASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103946 0 1 7122002
POWDER INTRAVENOUS SINGLE-DOSE VIAL
15 MG ( 15 MGVIAL )
103946 5020 2 162006
POWDER INTRAVENOUS SINGLE-DOSE VIAL
75 MG ( 75 MGVIAL )
Trade Name
Proper Name
BLASTN
761037 0
KEVZARA
SARILUMAB
Approval Date Product
5222017 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MG114 ML ( 13158 MGML )
761037 0 2 5222017
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MG114 ML ( 17544 MGML )
761037 1 3 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MG114 ML ( 13158 MGML )
761037 1 4 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
200 MG114 ML ( 17544 MGML )
Trade Name
Proper Name
BLASTN
103362 0
LEUKINE
SARGRAMOSTIM
Approval Date Product
351991 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
250 MCG ( 250 MCGVIAL )
103362 0 2 351991
SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL
500 MCGML ( 500 MCGML )
Trade Name PRALUENT
March 2018 Page 35 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Proper Name ALIROCUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125559 0 1 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 2 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 3 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125559 0 4 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name ZALTRAP
Proper Name ZIV-AFLIBERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125418 0 1 832012 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125418 0 2 832012 200 MG8 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SEATTLE GENETICS INC 1853
Trade Name ADCETRIS
Proper Name BRENTUXIMAB VEDOTIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125388 1 1 8192011 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 36 of 42
CDER Billable Biologic Product List
ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593
Trade Name ELAPRASE
Proper Name IDURSULFASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125151 0 1 7242006 6 MG3 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SICOR BIOTECH UAB 1803
Trade Name GRANIX
Proper Name TBO-FILGRASTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125294 0 1 8292012
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
300 MCG0 5 ML ( 600 MCGML )
125294 0 2 8292012
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
480 MCG08 ML ( 600 MCGML )
ApplicantLicense No SMITH AND NEPHEW INC 2004
Trade Name REGRANEX
Proper Name BECAPLERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103691 0 1 12161997
GEL TOPICAL
100 UG ( 100 UGGM )
Trade Name
Proper Name
SANTYL
COLLAGENASE
BLASTN
101995 0
Product
1
Approval Date
641965
PotencyDosage FormRoutePresentation
OINTMENT TOPICAL
30 G amp 90 G TUBE ( 250 UGRAM )
March 2018 Page 37 of 42
CDER Billable Biologic Product List
ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718
Trade Name MYOBLOC
Proper Name RIMABOTULINUM TOXIN B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103846 0 1 1282002
SOLUTION INTRAMUSCULAR
2500 IU05 ML ( 5000 IUML )
SINGLE-DOSE VIAL
103846 0 3 1282002
SOLUTION INTRAMUSCULAR
10000 IU2 ML ( 5000 IUML )
SINGLE-DOSE VIAL
Proper Name RIMABOTULINUMTOXINB
BLASTN
103846 0
Product
2
Approval Date
1282002
PotencyDosage FormRoutePresentation
SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL
5000 IUML ( 5000 IUML )
ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832
Trade Name ZEVALIN
Proper Name IBRITUMOMAB TIUXETAN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125019 0 1 2192002 32 MG2 ML ( 16 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
Trade Name KEPIVANCE
Proper Name PALIFERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125103 0 1 12152004 625 MG ( 625 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name KINERET
Proper Name ANAKINRA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 38 of 42
CDER Billable Biologic Product List
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898
Trade Name ENTYVIO
Proper Name VEDOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125476 0 1 5202014 300 MG ( 300 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No TEVA RESPIRATORY LLC 2047
Trade Name CINQAIR
Proper Name RESLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761033 0 1 3232016 100 MG10 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No THERATECHNOLOGIES INC 2091
Trade Name TROGARZO
Proper Name IBALIZUMAB-UIYK
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761065 0 1 362018 200 MG133 ML ( 150 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 39 of 42
CDER Billable Biologic Product List
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
0375 MG03 ML ( 125 MGML )2222017 125422 038 1
ApplicantLicense No UCB INC 1736
Trade Name CIMZIA
Proper Name CERTOLIZUMAB PEGOL
BLASTN Approval Date PotencyDosage FormRoutePresentation Product
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
200 MG ( 200 MGVIAL ) 4222008 125160 0 1
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )5132009 125160 080 2
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
Trade Name CRYSVITA
Proper Name BUROSUMAB-TWZA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761068 0 1 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
10 MGML ( 10 MGML )
761068 0 2 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
20 MGML ( 20 MGML )
761068 0
Trade Name
Proper Name
BLASTN
March 2018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML ) 4172018 3
MEPSEVII
VESTRONIDASE ALFA-VJBK
Approval Date PotencyDosage FormRoutePresentation Product
Page 40 of 42
CDER Billable Biologic Product List
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
761047 0 1 11152017 10 MG5 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No UNITED THERAPEUTICS CORP 1993
Trade Name UNITUXIN
Proper Name DINUTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125516 0 1 3102015 175 MG5 ML ( 35 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053
Trade Name SILIQ
Proper Name BRODALUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761032 0 1 2152017 210 MG15 ML ( 140 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 41 of 42
CDER Billable Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No WYETH PHARMACEUTICALS INC 0003
Trade Name BESPONSA
Proper Name INOTUZUMAB OZOGAMICIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761040 0 1 8172017 09 MG ( 09 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 42 of 42
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 1 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
9172001 103951 0 26
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
200 MCGML ( 200 MCGML ) 09272012
103951 0 27 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
200 MCG04 ML ( 500 MCGML ) 09272012
103951 0 28 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
300 MCGML ( 300 MCGML ) 09272012
103951 0 29 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
300 MCG06 ML ( 500 MCGML ) 09272012
103951 0 30 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
500 MCGML ( 500 MCGML ) 09272012
ApplicantLicense No ASTELLAS PHARMACEUTICALS US INC 1748
Trade Name AMEVIVE
Proper Name ALEFACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125036 0 1 1302003 75 MGVIAL ( 75 MGVIAL ) 09242008
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
125036 0 2 1302003 15 MGVIAL ( 15 MGVIAL ) 09282012
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No BOEHRINGER INGELHEIM PHARMA KG 1251
Trade Name VERLUMA
Proper Name NOFETUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103769 0 1 10131998 10 MGML ( 10 MGML ) 08132013
INTRAVENOUS
March 2018 Page 2 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No CENTOCOR ORTHO BIOTECH PRODUCTS LP 1824
Trade Name ORTHOCLONE OKT3
Proper Name MUROMONAB-CD3
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103463 0 1 9141992 1 MGML ( 1 MGML ) 01112012
SOLUTION INTRAVENOUS AMPULE
ApplicantLicense No EISAI INCORPORATED 1862
Trade Name ONTAK
Proper Name DENILEUKIN DIFTITOX
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103767 0 1 251999 300 MCG2 ML ( 150 MCGML ) 01302014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No ELI LILLY AND CO 1611
Trade Name XIGRIS
Proper Name DROTRECOGIN ALFA (ACTIVATED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125029 0 1 11212001 5 MGVIAL ( 5 MGVIAL ) 10262011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125029 0 2 11212001 20 MGVIAL ( 20 MGVIAL ) 10102011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GENENTECH INC 1048
Trade Name RAPTIVA
Proper Name EFALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125075 0 1 10272003 125 MGVIAL ( 125 MGVIAL ) 09012009
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
March 2018 Page 3 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103976 0 2 6202003 125 MGVIAL ( 125 MGVIAL ) 08252016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103948 0 3 572001 10 MGVIAL ( 10 MGVIAL ) 07062011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name MYOZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125141 0 1 4282006 50 MGVIAL ( 50 MGVIAL ) 10172014
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name BEXXAR THERAPEUTIC REGIME
Proper Name TOSITUMOMAB AND IODINE I-131 TOSITUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125011 0 1 6272003 01 MGML I-131 TOSITUMOMAB ( 01 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 2 6272003 11 MGML I-131 TOSITUMOMAB ( 11 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 3 6272003 14 MGML TOSITUMOMAB ( 14 MGML 03102014 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 4 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No HEMISPHERX BIOPHARMA INC 1703
Trade Name ALFERON N INJECTION
Proper Name INTERFERON ALFA-N3 (HUMAN LEUKOCYTE DERIVED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103158 0 1 10101989 5 MIUVIAL ( 5 MIUVIAL ) 06272013
SOLUTION INTRALESIONAL MULTI-DOSE VIAL
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name ROFERON A
Proper Name INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103145 0 1 641986 3 MIU05 ML ( 3 MIU05 ML ) 06012009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name ZENAPAX
Proper Name DACLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103749 0 1 12101997 25 MG5 ML ( 25 MG5 ML ) 07072011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No KADMON PHARMACEUTICALS LLC 1867
Trade Name INFERGEN
Proper Name INTERFERON ALFACON-1
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103663 0 1 1061997 9 MCG03 ML ( 30 MCGML ) 07252013
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 5 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103770 0 3 6191998 50 MGVIAL ( 50 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
103770 0 4 6191998 100 MGVIAL ( 100 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name INTRON A
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103132 0 6 641986 10 MIUML ( 10 MIUML ) 09232013
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103132 0 7 641986 225 MIU15 ML ( 225 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 8 641986 375 MIU15 ML ( 375 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 9 641986 75 MIU15 ML ( 75 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103949 0 5 1192001 675 MCGPEN ( 675 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 6 1192001 108 MCGPEN ( 108 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
March 2018 Page 6 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name PEGINTRON
103949 0 7 1192001 1184 MCGVIAL ( 1184 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 8 1192001 162 MCGPEN ( 162 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 9 1192001 1776 MCGVIAL ( 1776 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 10 1192001 2025 MCGPEN ( 2025 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 11 1192001 222 MCGVIAL ( 222 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No PALATIN TECHNOLOGIES INC 1588
Trade Name NEUTROSPEC TECHNETIUM (99M TC)
Proper Name FANOLESOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103928 0 1 722004 025 MGVIAL ( 025 MGVIAL ) 09222008
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No RECORDATI RARE DISEASES INC 1899
Trade Name ELSPAR
Proper Name ASPARAGINASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
101063 0 1 1101978 10000 IU ( 10000 IUVIAL ) 04092014
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
March 2018 Page 7 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No SCHERING CORP 0994
Trade Name PEGINTRONREBETOL COMBO PACK
Proper Name PEGINTERFERON ALFA-2B AND RIBAVIRIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125196 0 1 6132008 ( 4 (120 MCG05ML) REDIPEN amp 140 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 2 6132008 ( 4 (150 MCG05ML) REDIPEN amp 168 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 3 6132008 ( 4 (150 MCG05ML) REDIPEN amp 196 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 4 6132008 ( 4 (50 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 5 6132008 ( 4 (80 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125422 0 2 10172012 05 MG ( 25 MGML ) 08082017
SOLUTION INTRAVETREAL SINGLE-DOSE VIAL
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125164 0 10 11142007 50 MCGML ( 50 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 8 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
125164 0 11 11142007 100 MCGML ( 100 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 12 11142007 200 MCGML ( 200 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 13 11142007 300 MCGML ( 300 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 14 11142007 400 MCGML ( 400 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 15 11142007 400 MCG06 ML ( 400 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 16 11142007 600 MCGML ( 600 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 17 11142007 600 MCG06 ML ( 600 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 18 11142007 800 MCG06 ML ( 800 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 19 11142007 1000 MCGML ( 1000 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 9 of 9
CDER Billable Biologic Product List
ApplicantLicense No DYAX CORPORATION 1789
Trade Name KALBITOR
Proper Name ECALLANTIDE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125277 0 1 1212009 10 MGML ( 10 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No EKR THERAPEUTICS INC 1814
Trade Name RETAVASE
Proper Name RETEPLASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103786 0 1 561998 10 U ( 10 UVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No ELI LILLY AND CO 1891
Trade Name CYRAMZA
Proper Name RAMUCIRUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125477 0 1 4212014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG10 ML ( 10 MGML )
125477 0 2 4212014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
500 MG50 ML ( 10 MGML )
Trade Name
Proper Name
BLASTN
761038 0
LARTRUVO
OLARATUMAB
Approval Date Product
10192016 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
500 MG50 ML ( 10 MGML )
761038 0 2 10192016
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
190 MG19 ML ( 10 MGML )
March 2018 Page 15 of 42
CDER Billable Biologic Product List
ApplicantLicense No ELI LILLY AND CO 1891
Trade Name PORTRAZZA
Proper Name NECITUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125547 0 1 11242015
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
800 MG50 ML ( 16 MGML )
Trade Name
Proper Name
TALTZ
IXEKIZUMAB
BLASTN
125521 0
Product
1
Approval Date
3222016
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
80 MGML ( 80 MGML )
125521 0 2 3222016
SOLUTION SUBCUTANEOUS AUTOINJECTOR
80 MGML ( 80 MGML )
Trade Name
Proper Name
TRULICITY
DULAGLUTIDE
BLASTN
125469 0
Product
1
Approval Date
9182014
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
075 MG05 ML ( 075 MG05 ML )
125469 0 2 9182014
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
15 MG05 ML ( 15 MG05 ML )
125469 0 3 9182014
SOLUTION SUBCUTANEOUS AUTOINJECTOR
075 MG05 ML ( 075 MG05 ML )
125469 0 4 9182014
SOLUTION SUBCUTANEOUS AUTOINJECTOR
15 MG05 ML ( 15 MG05 ML )
March 2018 Page 16 of 42
CDER Billable Biologic Product List
ApplicantLicense No ELUSYS THERAPEUTICS INC 1907
Trade Name ANTHIM
Proper Name OBILTOXAXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125509 1 1 3182016 600 MG6 ML ( 100 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No EMD SERONO INC 1773
Trade Name BAVENCIO
Proper Name AVELUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761049 0 1 3232017
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
200 MG10 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
103780 0
REBIF
INTERFERON BETA 1A
Approval Date Product
372002 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
88 MCG02 ML ( 44 MCGML )
103780 0 2 372002
SOLUTION SUBCUTANEOUS AUTOINJECTOR
88 MCG02 ML ( 44 MCGML )
103780 0 3 372002
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
22 MCG05 ML ( 44 MCGML )
103780 0 4 372002
SOLUTION SUBCUTANEOUS AUTOINJECTOR
22 MCG05 ML ( 44 MCGML )
103780 0 5 372002
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
44 MCG05 ML ( 88 MCGML )
103780 0 6 372002
SOLUTION SUBCUTANEOUS AUTOINJECTOR
44 MCG05 ML ( 88 MCGML )
March 2018 Page 17 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name ACTEMRA
Proper Name TOCILIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125276 0 1 182010
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
80 MG4 ML ( 20 MGML )
125276 0 2 182010
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
200 MG10 ML ( 20 MGML )
125276 0 3 182010
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
400 MG20 ML ( 20 MGML )
BLASTN
125472 1
Product
1
Approval Date
10212013
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
162 MG09 ML ( 179 MGML )
Trade Name
Proper Name
BLASTN
103172 0
ACTIVASE
ALTEPLASE
Approval Date Product
11131987 2
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
50 MG ( 50 MGVIAL )
103172 0 3 11131987
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
BLASTN
125085 0
AVASTIN
BEVACIZUMAB
Approval Date Product
2262004 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG4 ML ( 25 MGML )
125085 0 2 2262004
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
400 MG16 ML ( 25 MGML )
March 2018 Page 18 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name CATHFLO ACTIVASE
Proper Name ALTEPLASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103172 0 1 11131987
POWDER INTRACATHETER SINGLE-DOSE VIAL
2 MG ( 2 MGVIAL )
Trade Name
Proper Name
BLASTN
125486 0
GAZYVA
OBINUYUZUMAB
Approval Date Product
1112013 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1000 MG40 ML ( 25 MGML )
Trade Name
Proper Name
BLASTN
761083 0
HEMLIBRA
EMICIZUMAB-KXWH
Approval Date Product
11162017 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML )
761083 0 2 11162017
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
60 MG04 ML ( 150 MGML )
761083 0 3 11162017
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
105 MG07 ML ( 150 MGML )
761083 0 4 11162017
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
150 MGML ( 150 MGML )
Trade Name
Proper Name
BLASTN
103792 0
HERCEPTIN
TRASTUZUMAB
Approval Date Product
9251998 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS MULTI-DOSE VIAL
420 MG ( 420 MGVIAL )
March 2018 Page 19 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
103792 5336 2 2102017 150 MG ( 150 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name KADCYLA
Proper Name ADO-TRASIUZUMAB EMTANSINE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125427 0 1 2222013
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
125427 0 2 2222013
POWDER INTRAVENOUS SINGLE-DOSE VIAL
160 MG ( 160 MGVIAL )
Trade Name
Proper Name
LUCENTIS
RANIBIZUMAB
BLASTN
125156 0
Product
1
Approval Date
6302006
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE
05 MG005 ML ( 10 MGML )
Proper Name RANIDIZUMAB
BLASTN
125156 076
Product
2
Approval Date
8102012
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE
03 MG005 ML ( 6 MGML )
Trade Name
Proper Name
OCREVUS
OCRELIZUMAB
BLASTN
761053 0
Product
1
Approval Date
3282017
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
300 MG10 ML ( 30 MGML )
Trade Name
Proper Name
PERJETA
PERTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 20 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
125409 0 1 682012 420 MG14 ML ( 30 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name PULMOZYME
Proper Name DORNASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103532 0 1 12301993 25 MG25 ML ( 1 MGML )
SOLUTION INHALATION AMPULE
Trade Name RITUXAN
Proper Name RITUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103705 0 1 11261997 100 MG10 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
103705 0 2 11261997 500 MG50 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name RITUXAN HYCELA
Proper Name RITUXIMAB AND HYALURONIDASE HUMAN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761064 0 1 6222017 1400 MG AND 23400 U117 ML ( 11966 MG AND 2000 UML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
761064 0 2 6222017 1600 MG AND 26800 U134 ML ( 11966 MG AND 2000 UML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name TECENTRIQ
Proper Name ATEZOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761034 0 1 582016 1200 MG20 ML ( 60 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name TNKASE
March 2018 Page 21 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Proper Name TENECTEPLASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103909 0 1 622000 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103976 0 1 6202003 150 MG ( 150 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103948 0 1 572001
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML )
Trade Name
Proper Name
FABRAZYME
AGALSIDASE BETA
BLASTN
103979 0
Product
1
Approval Date
4242003
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
5 MG ( 5 MGVIAL )
103979 0 2 4242003
POWDER INTRAVENOUS SINGLE-DOSE VIAL
35 MG ( 35 MGVIAL )
Trade Name
Proper Name
LEMTRADA
ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 22 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENZYME CORP 1596
103948 5139 2 11142014 12 MG12 ML ( 10MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name LUMIZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125291 0 1 5242010 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name NUCALA
Proper Name MEPOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125526 0 1 11142015
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
TANZEUM
ALBIGLUTIDE
BLASTN
125431 0
Product
1
Approval Date
4152014
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS AUTOINJECTOR
30 MG ( 30 MGAUTOINJECTOR )
125431 0 2 4152014
POWDER SUBCUTANEOUS AUTOINJECTOR
50 MG ( 50 MGAUTOINJECTOR )
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name PEGASYS
Proper Name PEGINTERFERON ALFA 2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103964 5204 4 9292011 180 MCG05 ML ( 360 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 23 of 42
CDER Billable Biologic Product List
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Proper Name PEG-INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103964 0 1 10162002 180 MCGML ( 180 MCGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
103964 0 2 10162002 180 MCG05 ML ( 360 MCGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
103964 5204 3 9292011 135 MCG05 ML ( 270 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
ApplicantLicense No HORIZON PHARMA IRELAND LTD 2022
Trade Name ACTIMMUNE
Proper Name INTERFERON GAMMA-1B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103836 0 1 2251999 100 MCG05 ML ( 200 MCGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No HORIZON PHARMA RHEUMATOLOGY LLC 1998
Trade Name KRYSTEXXA
Proper Name PEGLOTICASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125293 0 1 9142010 8MGML ( 8MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 24 of 42
CDER Billable Biologic Product List
ApplicantLicense No HUMAN GENOME SCIENCES INC 1820
Trade Name BENLYSTA
Proper Name BELIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125370 0 1 392011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
120 MG ( 120 MGVIAL )
125370 0 2 392011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
400 MG ( 400 MGVIAL )
125370 0 3 392011
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )
125370 0 4 392011
SOLUTION SUBCUTANEOUS AUTOINJECTOR
200 MGML ( 200 MGML )
BLASTN
761043 0
Product
1
Approval Date
7202017
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )
Trade Name
Proper Name
RAXIBACUMAB
RAXIBACUMAB
BLASTN
125349 0
Product
1
Approval Date
12142012
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1700 MG34 ML ( 50 MGML )
ApplicantLicense No IMCLONE LLC 1695
Trade Name ERBITUX
Proper Name CETUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125084 0 1 2122004 100 MG50 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 25 of 42
CDER Billable Biologic Product List
ApplicantLicense No IMCLONE LLC 1695
125084 0 2 2122004 200 MG100 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No IMMUNEX CORP 1132
Trade Name ENBREL
Proper Name ETANERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103795 0 1 1121998
POWDER SUBCUTANEOUS MULTI-DOSE VIAL
25 MG ( 25 MGVIAL )
103795 5184 2 9272004
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
50 MGML ( 50 MGML )
103795 0 3 9272004
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MGML ( 50 MGML )
103795 5184 4 9272004
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
25 MG05 ML ( 50 MGML )
103795 5556 5 9142017
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MGML ( 50 MGML )
ApplicantLicense No IPSEN BIOPHARM LIMITED 1787
Trade Name DYSPORT
Proper Name ABOBOTULINUMTOXINA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125274 0 1 4292009
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
300 UNITS ( 300 UNITSVIAL )
125274 0 2 4292009
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
500 UNITS ( 500 UNITSVIAL )
March 2018 Page 26 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
Trade Name DARZALEX
Proper Name DARATUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761036 0 1 11162015
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG5 ML ( 20 MGML )
761036 0 2 11162015
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
400 MG20 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
103772 0
REMICADE
INFLIXIMAB
Approval Date Product
8241998 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
BLASTN
103575 0
REOPRO
ABCIXIMAB
Approval Date Product
12221994 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
10 MG5 ML ( 2 MGML )
Trade Name
Proper Name
BLASTN
125289 0
SIMPONI
GOLIMUMAB
Approval Date Product
4242009 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
50 MG05 ML ( 100 MGML )
125289 0 2 4242009
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MG05 ML ( 100 MGML )
125289 0 3 4242009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
100 MGML ( 100 MGML )
March 2018 Page 27 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
125289 0 4 4242009 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name SIMPONI ARIA
Proper Name GOLIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125433 0 1 7182013 50 MG4 ML ( 125 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name STELARA
Proper Name USTEKINUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125261 0 1 9252009 90 MGML ( 90 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125261 0 2 9252009 45 MG05 ML ( 90 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL amp PREFILLED SYRINGE
125261 0 3 9252009 130 MG26 ML ( 5 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761044 0 1 9232016 130 MG26 ML ( 5 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SYLVANT
Proper Name SILTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125496 0 1 4232014 100 MG ( 100 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125496 0 2 4232014 400 MG ( 400 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 28 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
Trade Name TREMFYA
Proper Name GUSELKUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761061 0 1 7132017 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No JAZZ PHARMACEUTICALS INC 1901
Trade Name ERWINAZE
Proper Name ASPARAGINASE ERWINIA CHRYSANTHEMI
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
105359 0 1 11182011 10000 IU ( 10000 IUVIAL )
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103770 0 1 6191998
SOLUTION INTRAMUSCULAR
50 MG05 ML ( 100 MGML )
SINGLE-DOSE VIAL
103770 0 2 6191998
SOLUTION INTRAMUSCULAR
100 MGML ( 100 MGML )
SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name ILUMYA
Proper Name TILDRAKIZUMAB-ASMN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761067 0 1 3202018 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name INTRON A
March 2018 Page 29 of 42
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103132 0 1 641986 10 MIU ( 10 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL INTRAVENOUS SINGLE-DOSE VIAL
103132 0 2 641986 18 MIU ( 18 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL
103132 0 3 641986 50 MIU ( 50 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL
103132 0 4 641986 228 MIU38 ML ( 6 MIUML )
SOLUTION INTRAMUSCULAR SUBCUTANEOUS MULTI-DOSE VIAL
103132 0 5 641986 32 MIU32 ML ( 10 MIUML )
SOLUTION INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL MULTI-DOSE VIAL
Trade Name KEYTRUDA
Proper Name PEMBROLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125514 0 1 942014 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125514 1 2 1152015 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 0 1 1192001 74 MCG ( 74 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SYLATRON
Proper Name PEGINTERFERON ALFA-2B
March 2018 Page 30 of 42
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 5153 2 3292011 296 MCG ( 296 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 3 3292011 444 MCG ( 444 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 4 3292011 888 MCG ( 888 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name ZINPLAVA
Proper Name BEZLOTOXUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761046 0 1 10212016 1000 MG40 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No MERZ PHARMACEUTICALS GMBH 1830
Trade Name XEOMIN
Proper Name INCOBOTULINUMTOXINA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125360 0 1 7302010
POWDER INTRAMUSCULAR
50 U ( 50 UVIAL )
SINGLE-DOSE VIAL
125360 0 2 7302010
POWDER INTRAMUSCULAR
100 U ( 100 UVIAL )
SINGLE-DOSE VIAL
125360 3 3 11202015
POWDER INTRAMUSCULAR
200 U ( 200 UVIAL )
SINGLE-DOSE VIAL
March 2018 Page 31 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
Trade Name ARZERRA
Proper Name OFATUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125326 0 1 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG5 ML ( 20 MGML )
125326 0 2 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1000 MG50 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
125504 0
COSENTYX
SECUKINUMAB
Approval Date Product
1212015 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
150 MG ( 150 MGVIAL )
125504 0 2 1212015
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MGML ( 150 MGML )
125504 0 3 1212015
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MGML ( 150 MGML )
Trade Name
Proper Name
BLASTN
125290 0
EXTAVIA
INTERFERON BETA-1B
Approval Date Product
8142009 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
03 MG ( 03 MGVIAL )
Trade Name
Proper Name
BLASTN
125319 0
ILARIS
CANAKINUMAB
Approval Date Product
6172009 1
PotencyDosage FormRoutePresentation
180 MGVIAL ( 180 MGVIAL )
March 2018 Page 32 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
125319 88 2 12222016 150 MG ( 150 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
125319 0 3 12222016 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SIMULECT
Proper Name BASILIXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103764 0 1 5121998 10 MG ( 10 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
103764 0 2 5121998 20 MG ( 20 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No NPS PHARMACEUTICALS INC 1908
Trade Name NATPARA
Proper Name PARATHYROID HORMONE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 33 of 42
CDER Billable Biologic Product List
ApplicantLicense No PROMETHEUS LABORATORIES INC 1848
Trade Name PROLEUKIN
Proper Name ALDESLEUKIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103293 0 1 551992 22 MIU ( 22 MIUVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760
Trade Name ARCALYST
Proper Name RILONACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125249 0 1 2272008
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
220MG ( 220MGVIAL )
Trade Name
Proper Name
DUPIXENT
DUPILUMAB
BLASTN
761055 0
Product
1
Approval Date
3282017
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
300 MG2 ML ( 150 MGML )
Trade Name
Proper Name
EYLEA
AFLIBERCEPT
BLASTN
125387 0
Product
1
Approval Date
11182011
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
2 MG005 ML ( 40 MGML )
March 2018 Page 34 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Trade Name ELITEK
Proper Name RASBURICASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103946 0 1 7122002
POWDER INTRAVENOUS SINGLE-DOSE VIAL
15 MG ( 15 MGVIAL )
103946 5020 2 162006
POWDER INTRAVENOUS SINGLE-DOSE VIAL
75 MG ( 75 MGVIAL )
Trade Name
Proper Name
BLASTN
761037 0
KEVZARA
SARILUMAB
Approval Date Product
5222017 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MG114 ML ( 13158 MGML )
761037 0 2 5222017
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MG114 ML ( 17544 MGML )
761037 1 3 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MG114 ML ( 13158 MGML )
761037 1 4 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
200 MG114 ML ( 17544 MGML )
Trade Name
Proper Name
BLASTN
103362 0
LEUKINE
SARGRAMOSTIM
Approval Date Product
351991 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
250 MCG ( 250 MCGVIAL )
103362 0 2 351991
SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL
500 MCGML ( 500 MCGML )
Trade Name PRALUENT
March 2018 Page 35 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Proper Name ALIROCUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125559 0 1 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 2 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 3 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125559 0 4 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name ZALTRAP
Proper Name ZIV-AFLIBERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125418 0 1 832012 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125418 0 2 832012 200 MG8 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SEATTLE GENETICS INC 1853
Trade Name ADCETRIS
Proper Name BRENTUXIMAB VEDOTIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125388 1 1 8192011 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 36 of 42
CDER Billable Biologic Product List
ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593
Trade Name ELAPRASE
Proper Name IDURSULFASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125151 0 1 7242006 6 MG3 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SICOR BIOTECH UAB 1803
Trade Name GRANIX
Proper Name TBO-FILGRASTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125294 0 1 8292012
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
300 MCG0 5 ML ( 600 MCGML )
125294 0 2 8292012
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
480 MCG08 ML ( 600 MCGML )
ApplicantLicense No SMITH AND NEPHEW INC 2004
Trade Name REGRANEX
Proper Name BECAPLERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103691 0 1 12161997
GEL TOPICAL
100 UG ( 100 UGGM )
Trade Name
Proper Name
SANTYL
COLLAGENASE
BLASTN
101995 0
Product
1
Approval Date
641965
PotencyDosage FormRoutePresentation
OINTMENT TOPICAL
30 G amp 90 G TUBE ( 250 UGRAM )
March 2018 Page 37 of 42
CDER Billable Biologic Product List
ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718
Trade Name MYOBLOC
Proper Name RIMABOTULINUM TOXIN B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103846 0 1 1282002
SOLUTION INTRAMUSCULAR
2500 IU05 ML ( 5000 IUML )
SINGLE-DOSE VIAL
103846 0 3 1282002
SOLUTION INTRAMUSCULAR
10000 IU2 ML ( 5000 IUML )
SINGLE-DOSE VIAL
Proper Name RIMABOTULINUMTOXINB
BLASTN
103846 0
Product
2
Approval Date
1282002
PotencyDosage FormRoutePresentation
SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL
5000 IUML ( 5000 IUML )
ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832
Trade Name ZEVALIN
Proper Name IBRITUMOMAB TIUXETAN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125019 0 1 2192002 32 MG2 ML ( 16 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
Trade Name KEPIVANCE
Proper Name PALIFERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125103 0 1 12152004 625 MG ( 625 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name KINERET
Proper Name ANAKINRA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 38 of 42
CDER Billable Biologic Product List
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898
Trade Name ENTYVIO
Proper Name VEDOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125476 0 1 5202014 300 MG ( 300 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No TEVA RESPIRATORY LLC 2047
Trade Name CINQAIR
Proper Name RESLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761033 0 1 3232016 100 MG10 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No THERATECHNOLOGIES INC 2091
Trade Name TROGARZO
Proper Name IBALIZUMAB-UIYK
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761065 0 1 362018 200 MG133 ML ( 150 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 39 of 42
CDER Billable Biologic Product List
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
0375 MG03 ML ( 125 MGML )2222017 125422 038 1
ApplicantLicense No UCB INC 1736
Trade Name CIMZIA
Proper Name CERTOLIZUMAB PEGOL
BLASTN Approval Date PotencyDosage FormRoutePresentation Product
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
200 MG ( 200 MGVIAL ) 4222008 125160 0 1
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )5132009 125160 080 2
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
Trade Name CRYSVITA
Proper Name BUROSUMAB-TWZA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761068 0 1 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
10 MGML ( 10 MGML )
761068 0 2 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
20 MGML ( 20 MGML )
761068 0
Trade Name
Proper Name
BLASTN
March 2018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML ) 4172018 3
MEPSEVII
VESTRONIDASE ALFA-VJBK
Approval Date PotencyDosage FormRoutePresentation Product
Page 40 of 42
CDER Billable Biologic Product List
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
761047 0 1 11152017 10 MG5 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No UNITED THERAPEUTICS CORP 1993
Trade Name UNITUXIN
Proper Name DINUTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125516 0 1 3102015 175 MG5 ML ( 35 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053
Trade Name SILIQ
Proper Name BRODALUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761032 0 1 2152017 210 MG15 ML ( 140 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 41 of 42
CDER Billable Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No WYETH PHARMACEUTICALS INC 0003
Trade Name BESPONSA
Proper Name INOTUZUMAB OZOGAMICIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761040 0 1 8172017 09 MG ( 09 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 42 of 42
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 1 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
9172001 103951 0 26
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
200 MCGML ( 200 MCGML ) 09272012
103951 0 27 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
200 MCG04 ML ( 500 MCGML ) 09272012
103951 0 28 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
300 MCGML ( 300 MCGML ) 09272012
103951 0 29 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
300 MCG06 ML ( 500 MCGML ) 09272012
103951 0 30 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
500 MCGML ( 500 MCGML ) 09272012
ApplicantLicense No ASTELLAS PHARMACEUTICALS US INC 1748
Trade Name AMEVIVE
Proper Name ALEFACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125036 0 1 1302003 75 MGVIAL ( 75 MGVIAL ) 09242008
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
125036 0 2 1302003 15 MGVIAL ( 15 MGVIAL ) 09282012
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No BOEHRINGER INGELHEIM PHARMA KG 1251
Trade Name VERLUMA
Proper Name NOFETUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103769 0 1 10131998 10 MGML ( 10 MGML ) 08132013
INTRAVENOUS
March 2018 Page 2 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No CENTOCOR ORTHO BIOTECH PRODUCTS LP 1824
Trade Name ORTHOCLONE OKT3
Proper Name MUROMONAB-CD3
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103463 0 1 9141992 1 MGML ( 1 MGML ) 01112012
SOLUTION INTRAVENOUS AMPULE
ApplicantLicense No EISAI INCORPORATED 1862
Trade Name ONTAK
Proper Name DENILEUKIN DIFTITOX
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103767 0 1 251999 300 MCG2 ML ( 150 MCGML ) 01302014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No ELI LILLY AND CO 1611
Trade Name XIGRIS
Proper Name DROTRECOGIN ALFA (ACTIVATED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125029 0 1 11212001 5 MGVIAL ( 5 MGVIAL ) 10262011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125029 0 2 11212001 20 MGVIAL ( 20 MGVIAL ) 10102011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GENENTECH INC 1048
Trade Name RAPTIVA
Proper Name EFALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125075 0 1 10272003 125 MGVIAL ( 125 MGVIAL ) 09012009
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
March 2018 Page 3 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103976 0 2 6202003 125 MGVIAL ( 125 MGVIAL ) 08252016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103948 0 3 572001 10 MGVIAL ( 10 MGVIAL ) 07062011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name MYOZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125141 0 1 4282006 50 MGVIAL ( 50 MGVIAL ) 10172014
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name BEXXAR THERAPEUTIC REGIME
Proper Name TOSITUMOMAB AND IODINE I-131 TOSITUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125011 0 1 6272003 01 MGML I-131 TOSITUMOMAB ( 01 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 2 6272003 11 MGML I-131 TOSITUMOMAB ( 11 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 3 6272003 14 MGML TOSITUMOMAB ( 14 MGML 03102014 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 4 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No HEMISPHERX BIOPHARMA INC 1703
Trade Name ALFERON N INJECTION
Proper Name INTERFERON ALFA-N3 (HUMAN LEUKOCYTE DERIVED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103158 0 1 10101989 5 MIUVIAL ( 5 MIUVIAL ) 06272013
SOLUTION INTRALESIONAL MULTI-DOSE VIAL
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name ROFERON A
Proper Name INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103145 0 1 641986 3 MIU05 ML ( 3 MIU05 ML ) 06012009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name ZENAPAX
Proper Name DACLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103749 0 1 12101997 25 MG5 ML ( 25 MG5 ML ) 07072011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No KADMON PHARMACEUTICALS LLC 1867
Trade Name INFERGEN
Proper Name INTERFERON ALFACON-1
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103663 0 1 1061997 9 MCG03 ML ( 30 MCGML ) 07252013
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 5 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103770 0 3 6191998 50 MGVIAL ( 50 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
103770 0 4 6191998 100 MGVIAL ( 100 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name INTRON A
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103132 0 6 641986 10 MIUML ( 10 MIUML ) 09232013
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103132 0 7 641986 225 MIU15 ML ( 225 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 8 641986 375 MIU15 ML ( 375 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 9 641986 75 MIU15 ML ( 75 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103949 0 5 1192001 675 MCGPEN ( 675 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 6 1192001 108 MCGPEN ( 108 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
March 2018 Page 6 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name PEGINTRON
103949 0 7 1192001 1184 MCGVIAL ( 1184 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 8 1192001 162 MCGPEN ( 162 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 9 1192001 1776 MCGVIAL ( 1776 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 10 1192001 2025 MCGPEN ( 2025 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 11 1192001 222 MCGVIAL ( 222 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No PALATIN TECHNOLOGIES INC 1588
Trade Name NEUTROSPEC TECHNETIUM (99M TC)
Proper Name FANOLESOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103928 0 1 722004 025 MGVIAL ( 025 MGVIAL ) 09222008
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No RECORDATI RARE DISEASES INC 1899
Trade Name ELSPAR
Proper Name ASPARAGINASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
101063 0 1 1101978 10000 IU ( 10000 IUVIAL ) 04092014
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
March 2018 Page 7 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No SCHERING CORP 0994
Trade Name PEGINTRONREBETOL COMBO PACK
Proper Name PEGINTERFERON ALFA-2B AND RIBAVIRIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125196 0 1 6132008 ( 4 (120 MCG05ML) REDIPEN amp 140 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 2 6132008 ( 4 (150 MCG05ML) REDIPEN amp 168 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 3 6132008 ( 4 (150 MCG05ML) REDIPEN amp 196 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 4 6132008 ( 4 (50 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 5 6132008 ( 4 (80 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125422 0 2 10172012 05 MG ( 25 MGML ) 08082017
SOLUTION INTRAVETREAL SINGLE-DOSE VIAL
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125164 0 10 11142007 50 MCGML ( 50 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 8 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
125164 0 11 11142007 100 MCGML ( 100 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 12 11142007 200 MCGML ( 200 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 13 11142007 300 MCGML ( 300 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 14 11142007 400 MCGML ( 400 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 15 11142007 400 MCG06 ML ( 400 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 16 11142007 600 MCGML ( 600 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 17 11142007 600 MCG06 ML ( 600 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 18 11142007 800 MCG06 ML ( 800 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 19 11142007 1000 MCGML ( 1000 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 9 of 9
CDER Billable Biologic Product List
ApplicantLicense No ELI LILLY AND CO 1891
Trade Name PORTRAZZA
Proper Name NECITUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125547 0 1 11242015
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
800 MG50 ML ( 16 MGML )
Trade Name
Proper Name
TALTZ
IXEKIZUMAB
BLASTN
125521 0
Product
1
Approval Date
3222016
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
80 MGML ( 80 MGML )
125521 0 2 3222016
SOLUTION SUBCUTANEOUS AUTOINJECTOR
80 MGML ( 80 MGML )
Trade Name
Proper Name
TRULICITY
DULAGLUTIDE
BLASTN
125469 0
Product
1
Approval Date
9182014
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
075 MG05 ML ( 075 MG05 ML )
125469 0 2 9182014
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
15 MG05 ML ( 15 MG05 ML )
125469 0 3 9182014
SOLUTION SUBCUTANEOUS AUTOINJECTOR
075 MG05 ML ( 075 MG05 ML )
125469 0 4 9182014
SOLUTION SUBCUTANEOUS AUTOINJECTOR
15 MG05 ML ( 15 MG05 ML )
March 2018 Page 16 of 42
CDER Billable Biologic Product List
ApplicantLicense No ELUSYS THERAPEUTICS INC 1907
Trade Name ANTHIM
Proper Name OBILTOXAXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125509 1 1 3182016 600 MG6 ML ( 100 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No EMD SERONO INC 1773
Trade Name BAVENCIO
Proper Name AVELUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761049 0 1 3232017
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
200 MG10 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
103780 0
REBIF
INTERFERON BETA 1A
Approval Date Product
372002 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
88 MCG02 ML ( 44 MCGML )
103780 0 2 372002
SOLUTION SUBCUTANEOUS AUTOINJECTOR
88 MCG02 ML ( 44 MCGML )
103780 0 3 372002
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
22 MCG05 ML ( 44 MCGML )
103780 0 4 372002
SOLUTION SUBCUTANEOUS AUTOINJECTOR
22 MCG05 ML ( 44 MCGML )
103780 0 5 372002
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
44 MCG05 ML ( 88 MCGML )
103780 0 6 372002
SOLUTION SUBCUTANEOUS AUTOINJECTOR
44 MCG05 ML ( 88 MCGML )
March 2018 Page 17 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name ACTEMRA
Proper Name TOCILIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125276 0 1 182010
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
80 MG4 ML ( 20 MGML )
125276 0 2 182010
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
200 MG10 ML ( 20 MGML )
125276 0 3 182010
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
400 MG20 ML ( 20 MGML )
BLASTN
125472 1
Product
1
Approval Date
10212013
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
162 MG09 ML ( 179 MGML )
Trade Name
Proper Name
BLASTN
103172 0
ACTIVASE
ALTEPLASE
Approval Date Product
11131987 2
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
50 MG ( 50 MGVIAL )
103172 0 3 11131987
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
BLASTN
125085 0
AVASTIN
BEVACIZUMAB
Approval Date Product
2262004 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG4 ML ( 25 MGML )
125085 0 2 2262004
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
400 MG16 ML ( 25 MGML )
March 2018 Page 18 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name CATHFLO ACTIVASE
Proper Name ALTEPLASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103172 0 1 11131987
POWDER INTRACATHETER SINGLE-DOSE VIAL
2 MG ( 2 MGVIAL )
Trade Name
Proper Name
BLASTN
125486 0
GAZYVA
OBINUYUZUMAB
Approval Date Product
1112013 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1000 MG40 ML ( 25 MGML )
Trade Name
Proper Name
BLASTN
761083 0
HEMLIBRA
EMICIZUMAB-KXWH
Approval Date Product
11162017 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML )
761083 0 2 11162017
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
60 MG04 ML ( 150 MGML )
761083 0 3 11162017
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
105 MG07 ML ( 150 MGML )
761083 0 4 11162017
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
150 MGML ( 150 MGML )
Trade Name
Proper Name
BLASTN
103792 0
HERCEPTIN
TRASTUZUMAB
Approval Date Product
9251998 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS MULTI-DOSE VIAL
420 MG ( 420 MGVIAL )
March 2018 Page 19 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
103792 5336 2 2102017 150 MG ( 150 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name KADCYLA
Proper Name ADO-TRASIUZUMAB EMTANSINE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125427 0 1 2222013
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
125427 0 2 2222013
POWDER INTRAVENOUS SINGLE-DOSE VIAL
160 MG ( 160 MGVIAL )
Trade Name
Proper Name
LUCENTIS
RANIBIZUMAB
BLASTN
125156 0
Product
1
Approval Date
6302006
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE
05 MG005 ML ( 10 MGML )
Proper Name RANIDIZUMAB
BLASTN
125156 076
Product
2
Approval Date
8102012
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE
03 MG005 ML ( 6 MGML )
Trade Name
Proper Name
OCREVUS
OCRELIZUMAB
BLASTN
761053 0
Product
1
Approval Date
3282017
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
300 MG10 ML ( 30 MGML )
Trade Name
Proper Name
PERJETA
PERTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 20 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
125409 0 1 682012 420 MG14 ML ( 30 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name PULMOZYME
Proper Name DORNASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103532 0 1 12301993 25 MG25 ML ( 1 MGML )
SOLUTION INHALATION AMPULE
Trade Name RITUXAN
Proper Name RITUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103705 0 1 11261997 100 MG10 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
103705 0 2 11261997 500 MG50 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name RITUXAN HYCELA
Proper Name RITUXIMAB AND HYALURONIDASE HUMAN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761064 0 1 6222017 1400 MG AND 23400 U117 ML ( 11966 MG AND 2000 UML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
761064 0 2 6222017 1600 MG AND 26800 U134 ML ( 11966 MG AND 2000 UML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name TECENTRIQ
Proper Name ATEZOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761034 0 1 582016 1200 MG20 ML ( 60 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name TNKASE
March 2018 Page 21 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Proper Name TENECTEPLASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103909 0 1 622000 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103976 0 1 6202003 150 MG ( 150 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103948 0 1 572001
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML )
Trade Name
Proper Name
FABRAZYME
AGALSIDASE BETA
BLASTN
103979 0
Product
1
Approval Date
4242003
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
5 MG ( 5 MGVIAL )
103979 0 2 4242003
POWDER INTRAVENOUS SINGLE-DOSE VIAL
35 MG ( 35 MGVIAL )
Trade Name
Proper Name
LEMTRADA
ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 22 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENZYME CORP 1596
103948 5139 2 11142014 12 MG12 ML ( 10MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name LUMIZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125291 0 1 5242010 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name NUCALA
Proper Name MEPOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125526 0 1 11142015
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
TANZEUM
ALBIGLUTIDE
BLASTN
125431 0
Product
1
Approval Date
4152014
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS AUTOINJECTOR
30 MG ( 30 MGAUTOINJECTOR )
125431 0 2 4152014
POWDER SUBCUTANEOUS AUTOINJECTOR
50 MG ( 50 MGAUTOINJECTOR )
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name PEGASYS
Proper Name PEGINTERFERON ALFA 2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103964 5204 4 9292011 180 MCG05 ML ( 360 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 23 of 42
CDER Billable Biologic Product List
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Proper Name PEG-INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103964 0 1 10162002 180 MCGML ( 180 MCGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
103964 0 2 10162002 180 MCG05 ML ( 360 MCGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
103964 5204 3 9292011 135 MCG05 ML ( 270 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
ApplicantLicense No HORIZON PHARMA IRELAND LTD 2022
Trade Name ACTIMMUNE
Proper Name INTERFERON GAMMA-1B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103836 0 1 2251999 100 MCG05 ML ( 200 MCGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No HORIZON PHARMA RHEUMATOLOGY LLC 1998
Trade Name KRYSTEXXA
Proper Name PEGLOTICASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125293 0 1 9142010 8MGML ( 8MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 24 of 42
CDER Billable Biologic Product List
ApplicantLicense No HUMAN GENOME SCIENCES INC 1820
Trade Name BENLYSTA
Proper Name BELIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125370 0 1 392011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
120 MG ( 120 MGVIAL )
125370 0 2 392011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
400 MG ( 400 MGVIAL )
125370 0 3 392011
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )
125370 0 4 392011
SOLUTION SUBCUTANEOUS AUTOINJECTOR
200 MGML ( 200 MGML )
BLASTN
761043 0
Product
1
Approval Date
7202017
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )
Trade Name
Proper Name
RAXIBACUMAB
RAXIBACUMAB
BLASTN
125349 0
Product
1
Approval Date
12142012
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1700 MG34 ML ( 50 MGML )
ApplicantLicense No IMCLONE LLC 1695
Trade Name ERBITUX
Proper Name CETUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125084 0 1 2122004 100 MG50 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 25 of 42
CDER Billable Biologic Product List
ApplicantLicense No IMCLONE LLC 1695
125084 0 2 2122004 200 MG100 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No IMMUNEX CORP 1132
Trade Name ENBREL
Proper Name ETANERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103795 0 1 1121998
POWDER SUBCUTANEOUS MULTI-DOSE VIAL
25 MG ( 25 MGVIAL )
103795 5184 2 9272004
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
50 MGML ( 50 MGML )
103795 0 3 9272004
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MGML ( 50 MGML )
103795 5184 4 9272004
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
25 MG05 ML ( 50 MGML )
103795 5556 5 9142017
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MGML ( 50 MGML )
ApplicantLicense No IPSEN BIOPHARM LIMITED 1787
Trade Name DYSPORT
Proper Name ABOBOTULINUMTOXINA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125274 0 1 4292009
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
300 UNITS ( 300 UNITSVIAL )
125274 0 2 4292009
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
500 UNITS ( 500 UNITSVIAL )
March 2018 Page 26 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
Trade Name DARZALEX
Proper Name DARATUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761036 0 1 11162015
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG5 ML ( 20 MGML )
761036 0 2 11162015
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
400 MG20 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
103772 0
REMICADE
INFLIXIMAB
Approval Date Product
8241998 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
BLASTN
103575 0
REOPRO
ABCIXIMAB
Approval Date Product
12221994 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
10 MG5 ML ( 2 MGML )
Trade Name
Proper Name
BLASTN
125289 0
SIMPONI
GOLIMUMAB
Approval Date Product
4242009 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
50 MG05 ML ( 100 MGML )
125289 0 2 4242009
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MG05 ML ( 100 MGML )
125289 0 3 4242009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
100 MGML ( 100 MGML )
March 2018 Page 27 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
125289 0 4 4242009 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name SIMPONI ARIA
Proper Name GOLIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125433 0 1 7182013 50 MG4 ML ( 125 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name STELARA
Proper Name USTEKINUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125261 0 1 9252009 90 MGML ( 90 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125261 0 2 9252009 45 MG05 ML ( 90 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL amp PREFILLED SYRINGE
125261 0 3 9252009 130 MG26 ML ( 5 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761044 0 1 9232016 130 MG26 ML ( 5 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SYLVANT
Proper Name SILTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125496 0 1 4232014 100 MG ( 100 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125496 0 2 4232014 400 MG ( 400 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 28 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
Trade Name TREMFYA
Proper Name GUSELKUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761061 0 1 7132017 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No JAZZ PHARMACEUTICALS INC 1901
Trade Name ERWINAZE
Proper Name ASPARAGINASE ERWINIA CHRYSANTHEMI
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
105359 0 1 11182011 10000 IU ( 10000 IUVIAL )
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103770 0 1 6191998
SOLUTION INTRAMUSCULAR
50 MG05 ML ( 100 MGML )
SINGLE-DOSE VIAL
103770 0 2 6191998
SOLUTION INTRAMUSCULAR
100 MGML ( 100 MGML )
SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name ILUMYA
Proper Name TILDRAKIZUMAB-ASMN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761067 0 1 3202018 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name INTRON A
March 2018 Page 29 of 42
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103132 0 1 641986 10 MIU ( 10 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL INTRAVENOUS SINGLE-DOSE VIAL
103132 0 2 641986 18 MIU ( 18 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL
103132 0 3 641986 50 MIU ( 50 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL
103132 0 4 641986 228 MIU38 ML ( 6 MIUML )
SOLUTION INTRAMUSCULAR SUBCUTANEOUS MULTI-DOSE VIAL
103132 0 5 641986 32 MIU32 ML ( 10 MIUML )
SOLUTION INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL MULTI-DOSE VIAL
Trade Name KEYTRUDA
Proper Name PEMBROLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125514 0 1 942014 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125514 1 2 1152015 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 0 1 1192001 74 MCG ( 74 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SYLATRON
Proper Name PEGINTERFERON ALFA-2B
March 2018 Page 30 of 42
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 5153 2 3292011 296 MCG ( 296 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 3 3292011 444 MCG ( 444 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 4 3292011 888 MCG ( 888 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name ZINPLAVA
Proper Name BEZLOTOXUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761046 0 1 10212016 1000 MG40 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No MERZ PHARMACEUTICALS GMBH 1830
Trade Name XEOMIN
Proper Name INCOBOTULINUMTOXINA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125360 0 1 7302010
POWDER INTRAMUSCULAR
50 U ( 50 UVIAL )
SINGLE-DOSE VIAL
125360 0 2 7302010
POWDER INTRAMUSCULAR
100 U ( 100 UVIAL )
SINGLE-DOSE VIAL
125360 3 3 11202015
POWDER INTRAMUSCULAR
200 U ( 200 UVIAL )
SINGLE-DOSE VIAL
March 2018 Page 31 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
Trade Name ARZERRA
Proper Name OFATUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125326 0 1 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG5 ML ( 20 MGML )
125326 0 2 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1000 MG50 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
125504 0
COSENTYX
SECUKINUMAB
Approval Date Product
1212015 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
150 MG ( 150 MGVIAL )
125504 0 2 1212015
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MGML ( 150 MGML )
125504 0 3 1212015
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MGML ( 150 MGML )
Trade Name
Proper Name
BLASTN
125290 0
EXTAVIA
INTERFERON BETA-1B
Approval Date Product
8142009 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
03 MG ( 03 MGVIAL )
Trade Name
Proper Name
BLASTN
125319 0
ILARIS
CANAKINUMAB
Approval Date Product
6172009 1
PotencyDosage FormRoutePresentation
180 MGVIAL ( 180 MGVIAL )
March 2018 Page 32 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
125319 88 2 12222016 150 MG ( 150 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
125319 0 3 12222016 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SIMULECT
Proper Name BASILIXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103764 0 1 5121998 10 MG ( 10 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
103764 0 2 5121998 20 MG ( 20 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No NPS PHARMACEUTICALS INC 1908
Trade Name NATPARA
Proper Name PARATHYROID HORMONE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 33 of 42
CDER Billable Biologic Product List
ApplicantLicense No PROMETHEUS LABORATORIES INC 1848
Trade Name PROLEUKIN
Proper Name ALDESLEUKIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103293 0 1 551992 22 MIU ( 22 MIUVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760
Trade Name ARCALYST
Proper Name RILONACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125249 0 1 2272008
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
220MG ( 220MGVIAL )
Trade Name
Proper Name
DUPIXENT
DUPILUMAB
BLASTN
761055 0
Product
1
Approval Date
3282017
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
300 MG2 ML ( 150 MGML )
Trade Name
Proper Name
EYLEA
AFLIBERCEPT
BLASTN
125387 0
Product
1
Approval Date
11182011
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
2 MG005 ML ( 40 MGML )
March 2018 Page 34 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Trade Name ELITEK
Proper Name RASBURICASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103946 0 1 7122002
POWDER INTRAVENOUS SINGLE-DOSE VIAL
15 MG ( 15 MGVIAL )
103946 5020 2 162006
POWDER INTRAVENOUS SINGLE-DOSE VIAL
75 MG ( 75 MGVIAL )
Trade Name
Proper Name
BLASTN
761037 0
KEVZARA
SARILUMAB
Approval Date Product
5222017 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MG114 ML ( 13158 MGML )
761037 0 2 5222017
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MG114 ML ( 17544 MGML )
761037 1 3 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MG114 ML ( 13158 MGML )
761037 1 4 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
200 MG114 ML ( 17544 MGML )
Trade Name
Proper Name
BLASTN
103362 0
LEUKINE
SARGRAMOSTIM
Approval Date Product
351991 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
250 MCG ( 250 MCGVIAL )
103362 0 2 351991
SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL
500 MCGML ( 500 MCGML )
Trade Name PRALUENT
March 2018 Page 35 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Proper Name ALIROCUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125559 0 1 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 2 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 3 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125559 0 4 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name ZALTRAP
Proper Name ZIV-AFLIBERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125418 0 1 832012 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125418 0 2 832012 200 MG8 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SEATTLE GENETICS INC 1853
Trade Name ADCETRIS
Proper Name BRENTUXIMAB VEDOTIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125388 1 1 8192011 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 36 of 42
CDER Billable Biologic Product List
ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593
Trade Name ELAPRASE
Proper Name IDURSULFASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125151 0 1 7242006 6 MG3 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SICOR BIOTECH UAB 1803
Trade Name GRANIX
Proper Name TBO-FILGRASTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125294 0 1 8292012
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
300 MCG0 5 ML ( 600 MCGML )
125294 0 2 8292012
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
480 MCG08 ML ( 600 MCGML )
ApplicantLicense No SMITH AND NEPHEW INC 2004
Trade Name REGRANEX
Proper Name BECAPLERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103691 0 1 12161997
GEL TOPICAL
100 UG ( 100 UGGM )
Trade Name
Proper Name
SANTYL
COLLAGENASE
BLASTN
101995 0
Product
1
Approval Date
641965
PotencyDosage FormRoutePresentation
OINTMENT TOPICAL
30 G amp 90 G TUBE ( 250 UGRAM )
March 2018 Page 37 of 42
CDER Billable Biologic Product List
ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718
Trade Name MYOBLOC
Proper Name RIMABOTULINUM TOXIN B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103846 0 1 1282002
SOLUTION INTRAMUSCULAR
2500 IU05 ML ( 5000 IUML )
SINGLE-DOSE VIAL
103846 0 3 1282002
SOLUTION INTRAMUSCULAR
10000 IU2 ML ( 5000 IUML )
SINGLE-DOSE VIAL
Proper Name RIMABOTULINUMTOXINB
BLASTN
103846 0
Product
2
Approval Date
1282002
PotencyDosage FormRoutePresentation
SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL
5000 IUML ( 5000 IUML )
ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832
Trade Name ZEVALIN
Proper Name IBRITUMOMAB TIUXETAN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125019 0 1 2192002 32 MG2 ML ( 16 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
Trade Name KEPIVANCE
Proper Name PALIFERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125103 0 1 12152004 625 MG ( 625 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name KINERET
Proper Name ANAKINRA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 38 of 42
CDER Billable Biologic Product List
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898
Trade Name ENTYVIO
Proper Name VEDOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125476 0 1 5202014 300 MG ( 300 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No TEVA RESPIRATORY LLC 2047
Trade Name CINQAIR
Proper Name RESLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761033 0 1 3232016 100 MG10 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No THERATECHNOLOGIES INC 2091
Trade Name TROGARZO
Proper Name IBALIZUMAB-UIYK
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761065 0 1 362018 200 MG133 ML ( 150 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 39 of 42
CDER Billable Biologic Product List
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
0375 MG03 ML ( 125 MGML )2222017 125422 038 1
ApplicantLicense No UCB INC 1736
Trade Name CIMZIA
Proper Name CERTOLIZUMAB PEGOL
BLASTN Approval Date PotencyDosage FormRoutePresentation Product
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
200 MG ( 200 MGVIAL ) 4222008 125160 0 1
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )5132009 125160 080 2
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
Trade Name CRYSVITA
Proper Name BUROSUMAB-TWZA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761068 0 1 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
10 MGML ( 10 MGML )
761068 0 2 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
20 MGML ( 20 MGML )
761068 0
Trade Name
Proper Name
BLASTN
March 2018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML ) 4172018 3
MEPSEVII
VESTRONIDASE ALFA-VJBK
Approval Date PotencyDosage FormRoutePresentation Product
Page 40 of 42
CDER Billable Biologic Product List
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
761047 0 1 11152017 10 MG5 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No UNITED THERAPEUTICS CORP 1993
Trade Name UNITUXIN
Proper Name DINUTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125516 0 1 3102015 175 MG5 ML ( 35 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053
Trade Name SILIQ
Proper Name BRODALUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761032 0 1 2152017 210 MG15 ML ( 140 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 41 of 42
CDER Billable Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No WYETH PHARMACEUTICALS INC 0003
Trade Name BESPONSA
Proper Name INOTUZUMAB OZOGAMICIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761040 0 1 8172017 09 MG ( 09 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 42 of 42
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 1 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
9172001 103951 0 26
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
200 MCGML ( 200 MCGML ) 09272012
103951 0 27 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
200 MCG04 ML ( 500 MCGML ) 09272012
103951 0 28 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
300 MCGML ( 300 MCGML ) 09272012
103951 0 29 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
300 MCG06 ML ( 500 MCGML ) 09272012
103951 0 30 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
500 MCGML ( 500 MCGML ) 09272012
ApplicantLicense No ASTELLAS PHARMACEUTICALS US INC 1748
Trade Name AMEVIVE
Proper Name ALEFACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125036 0 1 1302003 75 MGVIAL ( 75 MGVIAL ) 09242008
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
125036 0 2 1302003 15 MGVIAL ( 15 MGVIAL ) 09282012
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No BOEHRINGER INGELHEIM PHARMA KG 1251
Trade Name VERLUMA
Proper Name NOFETUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103769 0 1 10131998 10 MGML ( 10 MGML ) 08132013
INTRAVENOUS
March 2018 Page 2 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No CENTOCOR ORTHO BIOTECH PRODUCTS LP 1824
Trade Name ORTHOCLONE OKT3
Proper Name MUROMONAB-CD3
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103463 0 1 9141992 1 MGML ( 1 MGML ) 01112012
SOLUTION INTRAVENOUS AMPULE
ApplicantLicense No EISAI INCORPORATED 1862
Trade Name ONTAK
Proper Name DENILEUKIN DIFTITOX
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103767 0 1 251999 300 MCG2 ML ( 150 MCGML ) 01302014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No ELI LILLY AND CO 1611
Trade Name XIGRIS
Proper Name DROTRECOGIN ALFA (ACTIVATED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125029 0 1 11212001 5 MGVIAL ( 5 MGVIAL ) 10262011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125029 0 2 11212001 20 MGVIAL ( 20 MGVIAL ) 10102011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GENENTECH INC 1048
Trade Name RAPTIVA
Proper Name EFALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125075 0 1 10272003 125 MGVIAL ( 125 MGVIAL ) 09012009
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
March 2018 Page 3 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103976 0 2 6202003 125 MGVIAL ( 125 MGVIAL ) 08252016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103948 0 3 572001 10 MGVIAL ( 10 MGVIAL ) 07062011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name MYOZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125141 0 1 4282006 50 MGVIAL ( 50 MGVIAL ) 10172014
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name BEXXAR THERAPEUTIC REGIME
Proper Name TOSITUMOMAB AND IODINE I-131 TOSITUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125011 0 1 6272003 01 MGML I-131 TOSITUMOMAB ( 01 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 2 6272003 11 MGML I-131 TOSITUMOMAB ( 11 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 3 6272003 14 MGML TOSITUMOMAB ( 14 MGML 03102014 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 4 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No HEMISPHERX BIOPHARMA INC 1703
Trade Name ALFERON N INJECTION
Proper Name INTERFERON ALFA-N3 (HUMAN LEUKOCYTE DERIVED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103158 0 1 10101989 5 MIUVIAL ( 5 MIUVIAL ) 06272013
SOLUTION INTRALESIONAL MULTI-DOSE VIAL
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name ROFERON A
Proper Name INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103145 0 1 641986 3 MIU05 ML ( 3 MIU05 ML ) 06012009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name ZENAPAX
Proper Name DACLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103749 0 1 12101997 25 MG5 ML ( 25 MG5 ML ) 07072011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No KADMON PHARMACEUTICALS LLC 1867
Trade Name INFERGEN
Proper Name INTERFERON ALFACON-1
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103663 0 1 1061997 9 MCG03 ML ( 30 MCGML ) 07252013
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 5 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103770 0 3 6191998 50 MGVIAL ( 50 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
103770 0 4 6191998 100 MGVIAL ( 100 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name INTRON A
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103132 0 6 641986 10 MIUML ( 10 MIUML ) 09232013
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103132 0 7 641986 225 MIU15 ML ( 225 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 8 641986 375 MIU15 ML ( 375 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 9 641986 75 MIU15 ML ( 75 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103949 0 5 1192001 675 MCGPEN ( 675 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 6 1192001 108 MCGPEN ( 108 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
March 2018 Page 6 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name PEGINTRON
103949 0 7 1192001 1184 MCGVIAL ( 1184 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 8 1192001 162 MCGPEN ( 162 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 9 1192001 1776 MCGVIAL ( 1776 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 10 1192001 2025 MCGPEN ( 2025 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 11 1192001 222 MCGVIAL ( 222 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No PALATIN TECHNOLOGIES INC 1588
Trade Name NEUTROSPEC TECHNETIUM (99M TC)
Proper Name FANOLESOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103928 0 1 722004 025 MGVIAL ( 025 MGVIAL ) 09222008
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No RECORDATI RARE DISEASES INC 1899
Trade Name ELSPAR
Proper Name ASPARAGINASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
101063 0 1 1101978 10000 IU ( 10000 IUVIAL ) 04092014
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
March 2018 Page 7 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No SCHERING CORP 0994
Trade Name PEGINTRONREBETOL COMBO PACK
Proper Name PEGINTERFERON ALFA-2B AND RIBAVIRIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125196 0 1 6132008 ( 4 (120 MCG05ML) REDIPEN amp 140 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 2 6132008 ( 4 (150 MCG05ML) REDIPEN amp 168 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 3 6132008 ( 4 (150 MCG05ML) REDIPEN amp 196 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 4 6132008 ( 4 (50 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 5 6132008 ( 4 (80 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125422 0 2 10172012 05 MG ( 25 MGML ) 08082017
SOLUTION INTRAVETREAL SINGLE-DOSE VIAL
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125164 0 10 11142007 50 MCGML ( 50 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 8 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
125164 0 11 11142007 100 MCGML ( 100 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 12 11142007 200 MCGML ( 200 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 13 11142007 300 MCGML ( 300 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 14 11142007 400 MCGML ( 400 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 15 11142007 400 MCG06 ML ( 400 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 16 11142007 600 MCGML ( 600 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 17 11142007 600 MCG06 ML ( 600 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 18 11142007 800 MCG06 ML ( 800 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 19 11142007 1000 MCGML ( 1000 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 9 of 9
CDER Billable Biologic Product List
ApplicantLicense No ELUSYS THERAPEUTICS INC 1907
Trade Name ANTHIM
Proper Name OBILTOXAXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125509 1 1 3182016 600 MG6 ML ( 100 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No EMD SERONO INC 1773
Trade Name BAVENCIO
Proper Name AVELUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761049 0 1 3232017
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
200 MG10 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
103780 0
REBIF
INTERFERON BETA 1A
Approval Date Product
372002 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
88 MCG02 ML ( 44 MCGML )
103780 0 2 372002
SOLUTION SUBCUTANEOUS AUTOINJECTOR
88 MCG02 ML ( 44 MCGML )
103780 0 3 372002
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
22 MCG05 ML ( 44 MCGML )
103780 0 4 372002
SOLUTION SUBCUTANEOUS AUTOINJECTOR
22 MCG05 ML ( 44 MCGML )
103780 0 5 372002
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
44 MCG05 ML ( 88 MCGML )
103780 0 6 372002
SOLUTION SUBCUTANEOUS AUTOINJECTOR
44 MCG05 ML ( 88 MCGML )
March 2018 Page 17 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name ACTEMRA
Proper Name TOCILIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125276 0 1 182010
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
80 MG4 ML ( 20 MGML )
125276 0 2 182010
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
200 MG10 ML ( 20 MGML )
125276 0 3 182010
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
400 MG20 ML ( 20 MGML )
BLASTN
125472 1
Product
1
Approval Date
10212013
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
162 MG09 ML ( 179 MGML )
Trade Name
Proper Name
BLASTN
103172 0
ACTIVASE
ALTEPLASE
Approval Date Product
11131987 2
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
50 MG ( 50 MGVIAL )
103172 0 3 11131987
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
BLASTN
125085 0
AVASTIN
BEVACIZUMAB
Approval Date Product
2262004 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG4 ML ( 25 MGML )
125085 0 2 2262004
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
400 MG16 ML ( 25 MGML )
March 2018 Page 18 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name CATHFLO ACTIVASE
Proper Name ALTEPLASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103172 0 1 11131987
POWDER INTRACATHETER SINGLE-DOSE VIAL
2 MG ( 2 MGVIAL )
Trade Name
Proper Name
BLASTN
125486 0
GAZYVA
OBINUYUZUMAB
Approval Date Product
1112013 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1000 MG40 ML ( 25 MGML )
Trade Name
Proper Name
BLASTN
761083 0
HEMLIBRA
EMICIZUMAB-KXWH
Approval Date Product
11162017 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML )
761083 0 2 11162017
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
60 MG04 ML ( 150 MGML )
761083 0 3 11162017
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
105 MG07 ML ( 150 MGML )
761083 0 4 11162017
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
150 MGML ( 150 MGML )
Trade Name
Proper Name
BLASTN
103792 0
HERCEPTIN
TRASTUZUMAB
Approval Date Product
9251998 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS MULTI-DOSE VIAL
420 MG ( 420 MGVIAL )
March 2018 Page 19 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
103792 5336 2 2102017 150 MG ( 150 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name KADCYLA
Proper Name ADO-TRASIUZUMAB EMTANSINE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125427 0 1 2222013
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
125427 0 2 2222013
POWDER INTRAVENOUS SINGLE-DOSE VIAL
160 MG ( 160 MGVIAL )
Trade Name
Proper Name
LUCENTIS
RANIBIZUMAB
BLASTN
125156 0
Product
1
Approval Date
6302006
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE
05 MG005 ML ( 10 MGML )
Proper Name RANIDIZUMAB
BLASTN
125156 076
Product
2
Approval Date
8102012
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE
03 MG005 ML ( 6 MGML )
Trade Name
Proper Name
OCREVUS
OCRELIZUMAB
BLASTN
761053 0
Product
1
Approval Date
3282017
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
300 MG10 ML ( 30 MGML )
Trade Name
Proper Name
PERJETA
PERTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 20 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
125409 0 1 682012 420 MG14 ML ( 30 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name PULMOZYME
Proper Name DORNASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103532 0 1 12301993 25 MG25 ML ( 1 MGML )
SOLUTION INHALATION AMPULE
Trade Name RITUXAN
Proper Name RITUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103705 0 1 11261997 100 MG10 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
103705 0 2 11261997 500 MG50 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name RITUXAN HYCELA
Proper Name RITUXIMAB AND HYALURONIDASE HUMAN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761064 0 1 6222017 1400 MG AND 23400 U117 ML ( 11966 MG AND 2000 UML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
761064 0 2 6222017 1600 MG AND 26800 U134 ML ( 11966 MG AND 2000 UML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name TECENTRIQ
Proper Name ATEZOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761034 0 1 582016 1200 MG20 ML ( 60 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name TNKASE
March 2018 Page 21 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Proper Name TENECTEPLASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103909 0 1 622000 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103976 0 1 6202003 150 MG ( 150 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103948 0 1 572001
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML )
Trade Name
Proper Name
FABRAZYME
AGALSIDASE BETA
BLASTN
103979 0
Product
1
Approval Date
4242003
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
5 MG ( 5 MGVIAL )
103979 0 2 4242003
POWDER INTRAVENOUS SINGLE-DOSE VIAL
35 MG ( 35 MGVIAL )
Trade Name
Proper Name
LEMTRADA
ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 22 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENZYME CORP 1596
103948 5139 2 11142014 12 MG12 ML ( 10MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name LUMIZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125291 0 1 5242010 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name NUCALA
Proper Name MEPOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125526 0 1 11142015
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
TANZEUM
ALBIGLUTIDE
BLASTN
125431 0
Product
1
Approval Date
4152014
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS AUTOINJECTOR
30 MG ( 30 MGAUTOINJECTOR )
125431 0 2 4152014
POWDER SUBCUTANEOUS AUTOINJECTOR
50 MG ( 50 MGAUTOINJECTOR )
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name PEGASYS
Proper Name PEGINTERFERON ALFA 2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103964 5204 4 9292011 180 MCG05 ML ( 360 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 23 of 42
CDER Billable Biologic Product List
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Proper Name PEG-INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103964 0 1 10162002 180 MCGML ( 180 MCGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
103964 0 2 10162002 180 MCG05 ML ( 360 MCGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
103964 5204 3 9292011 135 MCG05 ML ( 270 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
ApplicantLicense No HORIZON PHARMA IRELAND LTD 2022
Trade Name ACTIMMUNE
Proper Name INTERFERON GAMMA-1B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103836 0 1 2251999 100 MCG05 ML ( 200 MCGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No HORIZON PHARMA RHEUMATOLOGY LLC 1998
Trade Name KRYSTEXXA
Proper Name PEGLOTICASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125293 0 1 9142010 8MGML ( 8MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 24 of 42
CDER Billable Biologic Product List
ApplicantLicense No HUMAN GENOME SCIENCES INC 1820
Trade Name BENLYSTA
Proper Name BELIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125370 0 1 392011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
120 MG ( 120 MGVIAL )
125370 0 2 392011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
400 MG ( 400 MGVIAL )
125370 0 3 392011
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )
125370 0 4 392011
SOLUTION SUBCUTANEOUS AUTOINJECTOR
200 MGML ( 200 MGML )
BLASTN
761043 0
Product
1
Approval Date
7202017
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )
Trade Name
Proper Name
RAXIBACUMAB
RAXIBACUMAB
BLASTN
125349 0
Product
1
Approval Date
12142012
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1700 MG34 ML ( 50 MGML )
ApplicantLicense No IMCLONE LLC 1695
Trade Name ERBITUX
Proper Name CETUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125084 0 1 2122004 100 MG50 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 25 of 42
CDER Billable Biologic Product List
ApplicantLicense No IMCLONE LLC 1695
125084 0 2 2122004 200 MG100 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No IMMUNEX CORP 1132
Trade Name ENBREL
Proper Name ETANERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103795 0 1 1121998
POWDER SUBCUTANEOUS MULTI-DOSE VIAL
25 MG ( 25 MGVIAL )
103795 5184 2 9272004
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
50 MGML ( 50 MGML )
103795 0 3 9272004
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MGML ( 50 MGML )
103795 5184 4 9272004
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
25 MG05 ML ( 50 MGML )
103795 5556 5 9142017
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MGML ( 50 MGML )
ApplicantLicense No IPSEN BIOPHARM LIMITED 1787
Trade Name DYSPORT
Proper Name ABOBOTULINUMTOXINA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125274 0 1 4292009
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
300 UNITS ( 300 UNITSVIAL )
125274 0 2 4292009
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
500 UNITS ( 500 UNITSVIAL )
March 2018 Page 26 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
Trade Name DARZALEX
Proper Name DARATUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761036 0 1 11162015
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG5 ML ( 20 MGML )
761036 0 2 11162015
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
400 MG20 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
103772 0
REMICADE
INFLIXIMAB
Approval Date Product
8241998 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
BLASTN
103575 0
REOPRO
ABCIXIMAB
Approval Date Product
12221994 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
10 MG5 ML ( 2 MGML )
Trade Name
Proper Name
BLASTN
125289 0
SIMPONI
GOLIMUMAB
Approval Date Product
4242009 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
50 MG05 ML ( 100 MGML )
125289 0 2 4242009
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MG05 ML ( 100 MGML )
125289 0 3 4242009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
100 MGML ( 100 MGML )
March 2018 Page 27 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
125289 0 4 4242009 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name SIMPONI ARIA
Proper Name GOLIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125433 0 1 7182013 50 MG4 ML ( 125 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name STELARA
Proper Name USTEKINUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125261 0 1 9252009 90 MGML ( 90 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125261 0 2 9252009 45 MG05 ML ( 90 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL amp PREFILLED SYRINGE
125261 0 3 9252009 130 MG26 ML ( 5 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761044 0 1 9232016 130 MG26 ML ( 5 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SYLVANT
Proper Name SILTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125496 0 1 4232014 100 MG ( 100 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125496 0 2 4232014 400 MG ( 400 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 28 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
Trade Name TREMFYA
Proper Name GUSELKUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761061 0 1 7132017 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No JAZZ PHARMACEUTICALS INC 1901
Trade Name ERWINAZE
Proper Name ASPARAGINASE ERWINIA CHRYSANTHEMI
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
105359 0 1 11182011 10000 IU ( 10000 IUVIAL )
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103770 0 1 6191998
SOLUTION INTRAMUSCULAR
50 MG05 ML ( 100 MGML )
SINGLE-DOSE VIAL
103770 0 2 6191998
SOLUTION INTRAMUSCULAR
100 MGML ( 100 MGML )
SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name ILUMYA
Proper Name TILDRAKIZUMAB-ASMN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761067 0 1 3202018 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name INTRON A
March 2018 Page 29 of 42
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103132 0 1 641986 10 MIU ( 10 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL INTRAVENOUS SINGLE-DOSE VIAL
103132 0 2 641986 18 MIU ( 18 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL
103132 0 3 641986 50 MIU ( 50 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL
103132 0 4 641986 228 MIU38 ML ( 6 MIUML )
SOLUTION INTRAMUSCULAR SUBCUTANEOUS MULTI-DOSE VIAL
103132 0 5 641986 32 MIU32 ML ( 10 MIUML )
SOLUTION INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL MULTI-DOSE VIAL
Trade Name KEYTRUDA
Proper Name PEMBROLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125514 0 1 942014 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125514 1 2 1152015 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 0 1 1192001 74 MCG ( 74 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SYLATRON
Proper Name PEGINTERFERON ALFA-2B
March 2018 Page 30 of 42
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 5153 2 3292011 296 MCG ( 296 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 3 3292011 444 MCG ( 444 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 4 3292011 888 MCG ( 888 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name ZINPLAVA
Proper Name BEZLOTOXUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761046 0 1 10212016 1000 MG40 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No MERZ PHARMACEUTICALS GMBH 1830
Trade Name XEOMIN
Proper Name INCOBOTULINUMTOXINA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125360 0 1 7302010
POWDER INTRAMUSCULAR
50 U ( 50 UVIAL )
SINGLE-DOSE VIAL
125360 0 2 7302010
POWDER INTRAMUSCULAR
100 U ( 100 UVIAL )
SINGLE-DOSE VIAL
125360 3 3 11202015
POWDER INTRAMUSCULAR
200 U ( 200 UVIAL )
SINGLE-DOSE VIAL
March 2018 Page 31 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
Trade Name ARZERRA
Proper Name OFATUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125326 0 1 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG5 ML ( 20 MGML )
125326 0 2 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1000 MG50 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
125504 0
COSENTYX
SECUKINUMAB
Approval Date Product
1212015 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
150 MG ( 150 MGVIAL )
125504 0 2 1212015
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MGML ( 150 MGML )
125504 0 3 1212015
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MGML ( 150 MGML )
Trade Name
Proper Name
BLASTN
125290 0
EXTAVIA
INTERFERON BETA-1B
Approval Date Product
8142009 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
03 MG ( 03 MGVIAL )
Trade Name
Proper Name
BLASTN
125319 0
ILARIS
CANAKINUMAB
Approval Date Product
6172009 1
PotencyDosage FormRoutePresentation
180 MGVIAL ( 180 MGVIAL )
March 2018 Page 32 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
125319 88 2 12222016 150 MG ( 150 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
125319 0 3 12222016 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SIMULECT
Proper Name BASILIXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103764 0 1 5121998 10 MG ( 10 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
103764 0 2 5121998 20 MG ( 20 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No NPS PHARMACEUTICALS INC 1908
Trade Name NATPARA
Proper Name PARATHYROID HORMONE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 33 of 42
CDER Billable Biologic Product List
ApplicantLicense No PROMETHEUS LABORATORIES INC 1848
Trade Name PROLEUKIN
Proper Name ALDESLEUKIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103293 0 1 551992 22 MIU ( 22 MIUVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760
Trade Name ARCALYST
Proper Name RILONACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125249 0 1 2272008
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
220MG ( 220MGVIAL )
Trade Name
Proper Name
DUPIXENT
DUPILUMAB
BLASTN
761055 0
Product
1
Approval Date
3282017
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
300 MG2 ML ( 150 MGML )
Trade Name
Proper Name
EYLEA
AFLIBERCEPT
BLASTN
125387 0
Product
1
Approval Date
11182011
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
2 MG005 ML ( 40 MGML )
March 2018 Page 34 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Trade Name ELITEK
Proper Name RASBURICASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103946 0 1 7122002
POWDER INTRAVENOUS SINGLE-DOSE VIAL
15 MG ( 15 MGVIAL )
103946 5020 2 162006
POWDER INTRAVENOUS SINGLE-DOSE VIAL
75 MG ( 75 MGVIAL )
Trade Name
Proper Name
BLASTN
761037 0
KEVZARA
SARILUMAB
Approval Date Product
5222017 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MG114 ML ( 13158 MGML )
761037 0 2 5222017
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MG114 ML ( 17544 MGML )
761037 1 3 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MG114 ML ( 13158 MGML )
761037 1 4 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
200 MG114 ML ( 17544 MGML )
Trade Name
Proper Name
BLASTN
103362 0
LEUKINE
SARGRAMOSTIM
Approval Date Product
351991 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
250 MCG ( 250 MCGVIAL )
103362 0 2 351991
SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL
500 MCGML ( 500 MCGML )
Trade Name PRALUENT
March 2018 Page 35 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Proper Name ALIROCUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125559 0 1 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 2 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 3 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125559 0 4 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name ZALTRAP
Proper Name ZIV-AFLIBERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125418 0 1 832012 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125418 0 2 832012 200 MG8 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SEATTLE GENETICS INC 1853
Trade Name ADCETRIS
Proper Name BRENTUXIMAB VEDOTIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125388 1 1 8192011 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 36 of 42
CDER Billable Biologic Product List
ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593
Trade Name ELAPRASE
Proper Name IDURSULFASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125151 0 1 7242006 6 MG3 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SICOR BIOTECH UAB 1803
Trade Name GRANIX
Proper Name TBO-FILGRASTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125294 0 1 8292012
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
300 MCG0 5 ML ( 600 MCGML )
125294 0 2 8292012
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
480 MCG08 ML ( 600 MCGML )
ApplicantLicense No SMITH AND NEPHEW INC 2004
Trade Name REGRANEX
Proper Name BECAPLERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103691 0 1 12161997
GEL TOPICAL
100 UG ( 100 UGGM )
Trade Name
Proper Name
SANTYL
COLLAGENASE
BLASTN
101995 0
Product
1
Approval Date
641965
PotencyDosage FormRoutePresentation
OINTMENT TOPICAL
30 G amp 90 G TUBE ( 250 UGRAM )
March 2018 Page 37 of 42
CDER Billable Biologic Product List
ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718
Trade Name MYOBLOC
Proper Name RIMABOTULINUM TOXIN B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103846 0 1 1282002
SOLUTION INTRAMUSCULAR
2500 IU05 ML ( 5000 IUML )
SINGLE-DOSE VIAL
103846 0 3 1282002
SOLUTION INTRAMUSCULAR
10000 IU2 ML ( 5000 IUML )
SINGLE-DOSE VIAL
Proper Name RIMABOTULINUMTOXINB
BLASTN
103846 0
Product
2
Approval Date
1282002
PotencyDosage FormRoutePresentation
SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL
5000 IUML ( 5000 IUML )
ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832
Trade Name ZEVALIN
Proper Name IBRITUMOMAB TIUXETAN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125019 0 1 2192002 32 MG2 ML ( 16 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
Trade Name KEPIVANCE
Proper Name PALIFERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125103 0 1 12152004 625 MG ( 625 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name KINERET
Proper Name ANAKINRA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 38 of 42
CDER Billable Biologic Product List
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898
Trade Name ENTYVIO
Proper Name VEDOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125476 0 1 5202014 300 MG ( 300 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No TEVA RESPIRATORY LLC 2047
Trade Name CINQAIR
Proper Name RESLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761033 0 1 3232016 100 MG10 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No THERATECHNOLOGIES INC 2091
Trade Name TROGARZO
Proper Name IBALIZUMAB-UIYK
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761065 0 1 362018 200 MG133 ML ( 150 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 39 of 42
CDER Billable Biologic Product List
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
0375 MG03 ML ( 125 MGML )2222017 125422 038 1
ApplicantLicense No UCB INC 1736
Trade Name CIMZIA
Proper Name CERTOLIZUMAB PEGOL
BLASTN Approval Date PotencyDosage FormRoutePresentation Product
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
200 MG ( 200 MGVIAL ) 4222008 125160 0 1
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )5132009 125160 080 2
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
Trade Name CRYSVITA
Proper Name BUROSUMAB-TWZA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761068 0 1 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
10 MGML ( 10 MGML )
761068 0 2 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
20 MGML ( 20 MGML )
761068 0
Trade Name
Proper Name
BLASTN
March 2018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML ) 4172018 3
MEPSEVII
VESTRONIDASE ALFA-VJBK
Approval Date PotencyDosage FormRoutePresentation Product
Page 40 of 42
CDER Billable Biologic Product List
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
761047 0 1 11152017 10 MG5 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No UNITED THERAPEUTICS CORP 1993
Trade Name UNITUXIN
Proper Name DINUTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125516 0 1 3102015 175 MG5 ML ( 35 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053
Trade Name SILIQ
Proper Name BRODALUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761032 0 1 2152017 210 MG15 ML ( 140 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 41 of 42
CDER Billable Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No WYETH PHARMACEUTICALS INC 0003
Trade Name BESPONSA
Proper Name INOTUZUMAB OZOGAMICIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761040 0 1 8172017 09 MG ( 09 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 42 of 42
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 1 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
9172001 103951 0 26
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
200 MCGML ( 200 MCGML ) 09272012
103951 0 27 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
200 MCG04 ML ( 500 MCGML ) 09272012
103951 0 28 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
300 MCGML ( 300 MCGML ) 09272012
103951 0 29 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
300 MCG06 ML ( 500 MCGML ) 09272012
103951 0 30 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
500 MCGML ( 500 MCGML ) 09272012
ApplicantLicense No ASTELLAS PHARMACEUTICALS US INC 1748
Trade Name AMEVIVE
Proper Name ALEFACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125036 0 1 1302003 75 MGVIAL ( 75 MGVIAL ) 09242008
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
125036 0 2 1302003 15 MGVIAL ( 15 MGVIAL ) 09282012
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No BOEHRINGER INGELHEIM PHARMA KG 1251
Trade Name VERLUMA
Proper Name NOFETUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103769 0 1 10131998 10 MGML ( 10 MGML ) 08132013
INTRAVENOUS
March 2018 Page 2 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No CENTOCOR ORTHO BIOTECH PRODUCTS LP 1824
Trade Name ORTHOCLONE OKT3
Proper Name MUROMONAB-CD3
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103463 0 1 9141992 1 MGML ( 1 MGML ) 01112012
SOLUTION INTRAVENOUS AMPULE
ApplicantLicense No EISAI INCORPORATED 1862
Trade Name ONTAK
Proper Name DENILEUKIN DIFTITOX
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103767 0 1 251999 300 MCG2 ML ( 150 MCGML ) 01302014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No ELI LILLY AND CO 1611
Trade Name XIGRIS
Proper Name DROTRECOGIN ALFA (ACTIVATED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125029 0 1 11212001 5 MGVIAL ( 5 MGVIAL ) 10262011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125029 0 2 11212001 20 MGVIAL ( 20 MGVIAL ) 10102011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GENENTECH INC 1048
Trade Name RAPTIVA
Proper Name EFALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125075 0 1 10272003 125 MGVIAL ( 125 MGVIAL ) 09012009
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
March 2018 Page 3 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103976 0 2 6202003 125 MGVIAL ( 125 MGVIAL ) 08252016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103948 0 3 572001 10 MGVIAL ( 10 MGVIAL ) 07062011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name MYOZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125141 0 1 4282006 50 MGVIAL ( 50 MGVIAL ) 10172014
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name BEXXAR THERAPEUTIC REGIME
Proper Name TOSITUMOMAB AND IODINE I-131 TOSITUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125011 0 1 6272003 01 MGML I-131 TOSITUMOMAB ( 01 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 2 6272003 11 MGML I-131 TOSITUMOMAB ( 11 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 3 6272003 14 MGML TOSITUMOMAB ( 14 MGML 03102014 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 4 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No HEMISPHERX BIOPHARMA INC 1703
Trade Name ALFERON N INJECTION
Proper Name INTERFERON ALFA-N3 (HUMAN LEUKOCYTE DERIVED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103158 0 1 10101989 5 MIUVIAL ( 5 MIUVIAL ) 06272013
SOLUTION INTRALESIONAL MULTI-DOSE VIAL
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name ROFERON A
Proper Name INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103145 0 1 641986 3 MIU05 ML ( 3 MIU05 ML ) 06012009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name ZENAPAX
Proper Name DACLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103749 0 1 12101997 25 MG5 ML ( 25 MG5 ML ) 07072011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No KADMON PHARMACEUTICALS LLC 1867
Trade Name INFERGEN
Proper Name INTERFERON ALFACON-1
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103663 0 1 1061997 9 MCG03 ML ( 30 MCGML ) 07252013
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 5 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103770 0 3 6191998 50 MGVIAL ( 50 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
103770 0 4 6191998 100 MGVIAL ( 100 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name INTRON A
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103132 0 6 641986 10 MIUML ( 10 MIUML ) 09232013
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103132 0 7 641986 225 MIU15 ML ( 225 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 8 641986 375 MIU15 ML ( 375 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 9 641986 75 MIU15 ML ( 75 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103949 0 5 1192001 675 MCGPEN ( 675 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 6 1192001 108 MCGPEN ( 108 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
March 2018 Page 6 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name PEGINTRON
103949 0 7 1192001 1184 MCGVIAL ( 1184 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 8 1192001 162 MCGPEN ( 162 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 9 1192001 1776 MCGVIAL ( 1776 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 10 1192001 2025 MCGPEN ( 2025 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 11 1192001 222 MCGVIAL ( 222 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No PALATIN TECHNOLOGIES INC 1588
Trade Name NEUTROSPEC TECHNETIUM (99M TC)
Proper Name FANOLESOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103928 0 1 722004 025 MGVIAL ( 025 MGVIAL ) 09222008
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No RECORDATI RARE DISEASES INC 1899
Trade Name ELSPAR
Proper Name ASPARAGINASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
101063 0 1 1101978 10000 IU ( 10000 IUVIAL ) 04092014
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
March 2018 Page 7 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No SCHERING CORP 0994
Trade Name PEGINTRONREBETOL COMBO PACK
Proper Name PEGINTERFERON ALFA-2B AND RIBAVIRIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125196 0 1 6132008 ( 4 (120 MCG05ML) REDIPEN amp 140 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 2 6132008 ( 4 (150 MCG05ML) REDIPEN amp 168 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 3 6132008 ( 4 (150 MCG05ML) REDIPEN amp 196 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 4 6132008 ( 4 (50 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 5 6132008 ( 4 (80 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125422 0 2 10172012 05 MG ( 25 MGML ) 08082017
SOLUTION INTRAVETREAL SINGLE-DOSE VIAL
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125164 0 10 11142007 50 MCGML ( 50 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 8 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
125164 0 11 11142007 100 MCGML ( 100 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 12 11142007 200 MCGML ( 200 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 13 11142007 300 MCGML ( 300 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 14 11142007 400 MCGML ( 400 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 15 11142007 400 MCG06 ML ( 400 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 16 11142007 600 MCGML ( 600 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 17 11142007 600 MCG06 ML ( 600 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 18 11142007 800 MCG06 ML ( 800 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 19 11142007 1000 MCGML ( 1000 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 9 of 9
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name ACTEMRA
Proper Name TOCILIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125276 0 1 182010
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
80 MG4 ML ( 20 MGML )
125276 0 2 182010
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
200 MG10 ML ( 20 MGML )
125276 0 3 182010
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
400 MG20 ML ( 20 MGML )
BLASTN
125472 1
Product
1
Approval Date
10212013
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
162 MG09 ML ( 179 MGML )
Trade Name
Proper Name
BLASTN
103172 0
ACTIVASE
ALTEPLASE
Approval Date Product
11131987 2
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
50 MG ( 50 MGVIAL )
103172 0 3 11131987
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
BLASTN
125085 0
AVASTIN
BEVACIZUMAB
Approval Date Product
2262004 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG4 ML ( 25 MGML )
125085 0 2 2262004
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
400 MG16 ML ( 25 MGML )
March 2018 Page 18 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name CATHFLO ACTIVASE
Proper Name ALTEPLASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103172 0 1 11131987
POWDER INTRACATHETER SINGLE-DOSE VIAL
2 MG ( 2 MGVIAL )
Trade Name
Proper Name
BLASTN
125486 0
GAZYVA
OBINUYUZUMAB
Approval Date Product
1112013 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1000 MG40 ML ( 25 MGML )
Trade Name
Proper Name
BLASTN
761083 0
HEMLIBRA
EMICIZUMAB-KXWH
Approval Date Product
11162017 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML )
761083 0 2 11162017
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
60 MG04 ML ( 150 MGML )
761083 0 3 11162017
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
105 MG07 ML ( 150 MGML )
761083 0 4 11162017
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
150 MGML ( 150 MGML )
Trade Name
Proper Name
BLASTN
103792 0
HERCEPTIN
TRASTUZUMAB
Approval Date Product
9251998 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS MULTI-DOSE VIAL
420 MG ( 420 MGVIAL )
March 2018 Page 19 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
103792 5336 2 2102017 150 MG ( 150 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name KADCYLA
Proper Name ADO-TRASIUZUMAB EMTANSINE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125427 0 1 2222013
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
125427 0 2 2222013
POWDER INTRAVENOUS SINGLE-DOSE VIAL
160 MG ( 160 MGVIAL )
Trade Name
Proper Name
LUCENTIS
RANIBIZUMAB
BLASTN
125156 0
Product
1
Approval Date
6302006
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE
05 MG005 ML ( 10 MGML )
Proper Name RANIDIZUMAB
BLASTN
125156 076
Product
2
Approval Date
8102012
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE
03 MG005 ML ( 6 MGML )
Trade Name
Proper Name
OCREVUS
OCRELIZUMAB
BLASTN
761053 0
Product
1
Approval Date
3282017
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
300 MG10 ML ( 30 MGML )
Trade Name
Proper Name
PERJETA
PERTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 20 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
125409 0 1 682012 420 MG14 ML ( 30 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name PULMOZYME
Proper Name DORNASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103532 0 1 12301993 25 MG25 ML ( 1 MGML )
SOLUTION INHALATION AMPULE
Trade Name RITUXAN
Proper Name RITUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103705 0 1 11261997 100 MG10 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
103705 0 2 11261997 500 MG50 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name RITUXAN HYCELA
Proper Name RITUXIMAB AND HYALURONIDASE HUMAN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761064 0 1 6222017 1400 MG AND 23400 U117 ML ( 11966 MG AND 2000 UML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
761064 0 2 6222017 1600 MG AND 26800 U134 ML ( 11966 MG AND 2000 UML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name TECENTRIQ
Proper Name ATEZOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761034 0 1 582016 1200 MG20 ML ( 60 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name TNKASE
March 2018 Page 21 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Proper Name TENECTEPLASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103909 0 1 622000 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103976 0 1 6202003 150 MG ( 150 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103948 0 1 572001
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML )
Trade Name
Proper Name
FABRAZYME
AGALSIDASE BETA
BLASTN
103979 0
Product
1
Approval Date
4242003
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
5 MG ( 5 MGVIAL )
103979 0 2 4242003
POWDER INTRAVENOUS SINGLE-DOSE VIAL
35 MG ( 35 MGVIAL )
Trade Name
Proper Name
LEMTRADA
ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 22 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENZYME CORP 1596
103948 5139 2 11142014 12 MG12 ML ( 10MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name LUMIZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125291 0 1 5242010 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name NUCALA
Proper Name MEPOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125526 0 1 11142015
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
TANZEUM
ALBIGLUTIDE
BLASTN
125431 0
Product
1
Approval Date
4152014
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS AUTOINJECTOR
30 MG ( 30 MGAUTOINJECTOR )
125431 0 2 4152014
POWDER SUBCUTANEOUS AUTOINJECTOR
50 MG ( 50 MGAUTOINJECTOR )
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name PEGASYS
Proper Name PEGINTERFERON ALFA 2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103964 5204 4 9292011 180 MCG05 ML ( 360 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 23 of 42
CDER Billable Biologic Product List
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Proper Name PEG-INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103964 0 1 10162002 180 MCGML ( 180 MCGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
103964 0 2 10162002 180 MCG05 ML ( 360 MCGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
103964 5204 3 9292011 135 MCG05 ML ( 270 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
ApplicantLicense No HORIZON PHARMA IRELAND LTD 2022
Trade Name ACTIMMUNE
Proper Name INTERFERON GAMMA-1B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103836 0 1 2251999 100 MCG05 ML ( 200 MCGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No HORIZON PHARMA RHEUMATOLOGY LLC 1998
Trade Name KRYSTEXXA
Proper Name PEGLOTICASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125293 0 1 9142010 8MGML ( 8MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 24 of 42
CDER Billable Biologic Product List
ApplicantLicense No HUMAN GENOME SCIENCES INC 1820
Trade Name BENLYSTA
Proper Name BELIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125370 0 1 392011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
120 MG ( 120 MGVIAL )
125370 0 2 392011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
400 MG ( 400 MGVIAL )
125370 0 3 392011
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )
125370 0 4 392011
SOLUTION SUBCUTANEOUS AUTOINJECTOR
200 MGML ( 200 MGML )
BLASTN
761043 0
Product
1
Approval Date
7202017
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )
Trade Name
Proper Name
RAXIBACUMAB
RAXIBACUMAB
BLASTN
125349 0
Product
1
Approval Date
12142012
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1700 MG34 ML ( 50 MGML )
ApplicantLicense No IMCLONE LLC 1695
Trade Name ERBITUX
Proper Name CETUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125084 0 1 2122004 100 MG50 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 25 of 42
CDER Billable Biologic Product List
ApplicantLicense No IMCLONE LLC 1695
125084 0 2 2122004 200 MG100 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No IMMUNEX CORP 1132
Trade Name ENBREL
Proper Name ETANERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103795 0 1 1121998
POWDER SUBCUTANEOUS MULTI-DOSE VIAL
25 MG ( 25 MGVIAL )
103795 5184 2 9272004
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
50 MGML ( 50 MGML )
103795 0 3 9272004
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MGML ( 50 MGML )
103795 5184 4 9272004
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
25 MG05 ML ( 50 MGML )
103795 5556 5 9142017
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MGML ( 50 MGML )
ApplicantLicense No IPSEN BIOPHARM LIMITED 1787
Trade Name DYSPORT
Proper Name ABOBOTULINUMTOXINA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125274 0 1 4292009
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
300 UNITS ( 300 UNITSVIAL )
125274 0 2 4292009
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
500 UNITS ( 500 UNITSVIAL )
March 2018 Page 26 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
Trade Name DARZALEX
Proper Name DARATUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761036 0 1 11162015
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG5 ML ( 20 MGML )
761036 0 2 11162015
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
400 MG20 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
103772 0
REMICADE
INFLIXIMAB
Approval Date Product
8241998 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
BLASTN
103575 0
REOPRO
ABCIXIMAB
Approval Date Product
12221994 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
10 MG5 ML ( 2 MGML )
Trade Name
Proper Name
BLASTN
125289 0
SIMPONI
GOLIMUMAB
Approval Date Product
4242009 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
50 MG05 ML ( 100 MGML )
125289 0 2 4242009
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MG05 ML ( 100 MGML )
125289 0 3 4242009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
100 MGML ( 100 MGML )
March 2018 Page 27 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
125289 0 4 4242009 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name SIMPONI ARIA
Proper Name GOLIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125433 0 1 7182013 50 MG4 ML ( 125 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name STELARA
Proper Name USTEKINUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125261 0 1 9252009 90 MGML ( 90 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125261 0 2 9252009 45 MG05 ML ( 90 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL amp PREFILLED SYRINGE
125261 0 3 9252009 130 MG26 ML ( 5 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761044 0 1 9232016 130 MG26 ML ( 5 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SYLVANT
Proper Name SILTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125496 0 1 4232014 100 MG ( 100 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125496 0 2 4232014 400 MG ( 400 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 28 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
Trade Name TREMFYA
Proper Name GUSELKUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761061 0 1 7132017 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No JAZZ PHARMACEUTICALS INC 1901
Trade Name ERWINAZE
Proper Name ASPARAGINASE ERWINIA CHRYSANTHEMI
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
105359 0 1 11182011 10000 IU ( 10000 IUVIAL )
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103770 0 1 6191998
SOLUTION INTRAMUSCULAR
50 MG05 ML ( 100 MGML )
SINGLE-DOSE VIAL
103770 0 2 6191998
SOLUTION INTRAMUSCULAR
100 MGML ( 100 MGML )
SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name ILUMYA
Proper Name TILDRAKIZUMAB-ASMN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761067 0 1 3202018 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name INTRON A
March 2018 Page 29 of 42
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103132 0 1 641986 10 MIU ( 10 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL INTRAVENOUS SINGLE-DOSE VIAL
103132 0 2 641986 18 MIU ( 18 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL
103132 0 3 641986 50 MIU ( 50 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL
103132 0 4 641986 228 MIU38 ML ( 6 MIUML )
SOLUTION INTRAMUSCULAR SUBCUTANEOUS MULTI-DOSE VIAL
103132 0 5 641986 32 MIU32 ML ( 10 MIUML )
SOLUTION INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL MULTI-DOSE VIAL
Trade Name KEYTRUDA
Proper Name PEMBROLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125514 0 1 942014 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125514 1 2 1152015 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 0 1 1192001 74 MCG ( 74 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SYLATRON
Proper Name PEGINTERFERON ALFA-2B
March 2018 Page 30 of 42
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 5153 2 3292011 296 MCG ( 296 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 3 3292011 444 MCG ( 444 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 4 3292011 888 MCG ( 888 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name ZINPLAVA
Proper Name BEZLOTOXUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761046 0 1 10212016 1000 MG40 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No MERZ PHARMACEUTICALS GMBH 1830
Trade Name XEOMIN
Proper Name INCOBOTULINUMTOXINA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125360 0 1 7302010
POWDER INTRAMUSCULAR
50 U ( 50 UVIAL )
SINGLE-DOSE VIAL
125360 0 2 7302010
POWDER INTRAMUSCULAR
100 U ( 100 UVIAL )
SINGLE-DOSE VIAL
125360 3 3 11202015
POWDER INTRAMUSCULAR
200 U ( 200 UVIAL )
SINGLE-DOSE VIAL
March 2018 Page 31 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
Trade Name ARZERRA
Proper Name OFATUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125326 0 1 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG5 ML ( 20 MGML )
125326 0 2 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1000 MG50 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
125504 0
COSENTYX
SECUKINUMAB
Approval Date Product
1212015 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
150 MG ( 150 MGVIAL )
125504 0 2 1212015
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MGML ( 150 MGML )
125504 0 3 1212015
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MGML ( 150 MGML )
Trade Name
Proper Name
BLASTN
125290 0
EXTAVIA
INTERFERON BETA-1B
Approval Date Product
8142009 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
03 MG ( 03 MGVIAL )
Trade Name
Proper Name
BLASTN
125319 0
ILARIS
CANAKINUMAB
Approval Date Product
6172009 1
PotencyDosage FormRoutePresentation
180 MGVIAL ( 180 MGVIAL )
March 2018 Page 32 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
125319 88 2 12222016 150 MG ( 150 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
125319 0 3 12222016 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SIMULECT
Proper Name BASILIXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103764 0 1 5121998 10 MG ( 10 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
103764 0 2 5121998 20 MG ( 20 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No NPS PHARMACEUTICALS INC 1908
Trade Name NATPARA
Proper Name PARATHYROID HORMONE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 33 of 42
CDER Billable Biologic Product List
ApplicantLicense No PROMETHEUS LABORATORIES INC 1848
Trade Name PROLEUKIN
Proper Name ALDESLEUKIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103293 0 1 551992 22 MIU ( 22 MIUVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760
Trade Name ARCALYST
Proper Name RILONACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125249 0 1 2272008
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
220MG ( 220MGVIAL )
Trade Name
Proper Name
DUPIXENT
DUPILUMAB
BLASTN
761055 0
Product
1
Approval Date
3282017
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
300 MG2 ML ( 150 MGML )
Trade Name
Proper Name
EYLEA
AFLIBERCEPT
BLASTN
125387 0
Product
1
Approval Date
11182011
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
2 MG005 ML ( 40 MGML )
March 2018 Page 34 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Trade Name ELITEK
Proper Name RASBURICASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103946 0 1 7122002
POWDER INTRAVENOUS SINGLE-DOSE VIAL
15 MG ( 15 MGVIAL )
103946 5020 2 162006
POWDER INTRAVENOUS SINGLE-DOSE VIAL
75 MG ( 75 MGVIAL )
Trade Name
Proper Name
BLASTN
761037 0
KEVZARA
SARILUMAB
Approval Date Product
5222017 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MG114 ML ( 13158 MGML )
761037 0 2 5222017
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MG114 ML ( 17544 MGML )
761037 1 3 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MG114 ML ( 13158 MGML )
761037 1 4 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
200 MG114 ML ( 17544 MGML )
Trade Name
Proper Name
BLASTN
103362 0
LEUKINE
SARGRAMOSTIM
Approval Date Product
351991 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
250 MCG ( 250 MCGVIAL )
103362 0 2 351991
SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL
500 MCGML ( 500 MCGML )
Trade Name PRALUENT
March 2018 Page 35 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Proper Name ALIROCUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125559 0 1 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 2 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 3 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125559 0 4 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name ZALTRAP
Proper Name ZIV-AFLIBERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125418 0 1 832012 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125418 0 2 832012 200 MG8 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SEATTLE GENETICS INC 1853
Trade Name ADCETRIS
Proper Name BRENTUXIMAB VEDOTIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125388 1 1 8192011 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 36 of 42
CDER Billable Biologic Product List
ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593
Trade Name ELAPRASE
Proper Name IDURSULFASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125151 0 1 7242006 6 MG3 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SICOR BIOTECH UAB 1803
Trade Name GRANIX
Proper Name TBO-FILGRASTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125294 0 1 8292012
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
300 MCG0 5 ML ( 600 MCGML )
125294 0 2 8292012
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
480 MCG08 ML ( 600 MCGML )
ApplicantLicense No SMITH AND NEPHEW INC 2004
Trade Name REGRANEX
Proper Name BECAPLERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103691 0 1 12161997
GEL TOPICAL
100 UG ( 100 UGGM )
Trade Name
Proper Name
SANTYL
COLLAGENASE
BLASTN
101995 0
Product
1
Approval Date
641965
PotencyDosage FormRoutePresentation
OINTMENT TOPICAL
30 G amp 90 G TUBE ( 250 UGRAM )
March 2018 Page 37 of 42
CDER Billable Biologic Product List
ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718
Trade Name MYOBLOC
Proper Name RIMABOTULINUM TOXIN B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103846 0 1 1282002
SOLUTION INTRAMUSCULAR
2500 IU05 ML ( 5000 IUML )
SINGLE-DOSE VIAL
103846 0 3 1282002
SOLUTION INTRAMUSCULAR
10000 IU2 ML ( 5000 IUML )
SINGLE-DOSE VIAL
Proper Name RIMABOTULINUMTOXINB
BLASTN
103846 0
Product
2
Approval Date
1282002
PotencyDosage FormRoutePresentation
SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL
5000 IUML ( 5000 IUML )
ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832
Trade Name ZEVALIN
Proper Name IBRITUMOMAB TIUXETAN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125019 0 1 2192002 32 MG2 ML ( 16 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
Trade Name KEPIVANCE
Proper Name PALIFERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125103 0 1 12152004 625 MG ( 625 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name KINERET
Proper Name ANAKINRA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 38 of 42
CDER Billable Biologic Product List
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898
Trade Name ENTYVIO
Proper Name VEDOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125476 0 1 5202014 300 MG ( 300 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No TEVA RESPIRATORY LLC 2047
Trade Name CINQAIR
Proper Name RESLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761033 0 1 3232016 100 MG10 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No THERATECHNOLOGIES INC 2091
Trade Name TROGARZO
Proper Name IBALIZUMAB-UIYK
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761065 0 1 362018 200 MG133 ML ( 150 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 39 of 42
CDER Billable Biologic Product List
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
0375 MG03 ML ( 125 MGML )2222017 125422 038 1
ApplicantLicense No UCB INC 1736
Trade Name CIMZIA
Proper Name CERTOLIZUMAB PEGOL
BLASTN Approval Date PotencyDosage FormRoutePresentation Product
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
200 MG ( 200 MGVIAL ) 4222008 125160 0 1
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )5132009 125160 080 2
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
Trade Name CRYSVITA
Proper Name BUROSUMAB-TWZA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761068 0 1 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
10 MGML ( 10 MGML )
761068 0 2 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
20 MGML ( 20 MGML )
761068 0
Trade Name
Proper Name
BLASTN
March 2018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML ) 4172018 3
MEPSEVII
VESTRONIDASE ALFA-VJBK
Approval Date PotencyDosage FormRoutePresentation Product
Page 40 of 42
CDER Billable Biologic Product List
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
761047 0 1 11152017 10 MG5 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No UNITED THERAPEUTICS CORP 1993
Trade Name UNITUXIN
Proper Name DINUTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125516 0 1 3102015 175 MG5 ML ( 35 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053
Trade Name SILIQ
Proper Name BRODALUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761032 0 1 2152017 210 MG15 ML ( 140 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 41 of 42
CDER Billable Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No WYETH PHARMACEUTICALS INC 0003
Trade Name BESPONSA
Proper Name INOTUZUMAB OZOGAMICIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761040 0 1 8172017 09 MG ( 09 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 42 of 42
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 1 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
9172001 103951 0 26
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
200 MCGML ( 200 MCGML ) 09272012
103951 0 27 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
200 MCG04 ML ( 500 MCGML ) 09272012
103951 0 28 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
300 MCGML ( 300 MCGML ) 09272012
103951 0 29 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
300 MCG06 ML ( 500 MCGML ) 09272012
103951 0 30 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
500 MCGML ( 500 MCGML ) 09272012
ApplicantLicense No ASTELLAS PHARMACEUTICALS US INC 1748
Trade Name AMEVIVE
Proper Name ALEFACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125036 0 1 1302003 75 MGVIAL ( 75 MGVIAL ) 09242008
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
125036 0 2 1302003 15 MGVIAL ( 15 MGVIAL ) 09282012
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No BOEHRINGER INGELHEIM PHARMA KG 1251
Trade Name VERLUMA
Proper Name NOFETUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103769 0 1 10131998 10 MGML ( 10 MGML ) 08132013
INTRAVENOUS
March 2018 Page 2 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No CENTOCOR ORTHO BIOTECH PRODUCTS LP 1824
Trade Name ORTHOCLONE OKT3
Proper Name MUROMONAB-CD3
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103463 0 1 9141992 1 MGML ( 1 MGML ) 01112012
SOLUTION INTRAVENOUS AMPULE
ApplicantLicense No EISAI INCORPORATED 1862
Trade Name ONTAK
Proper Name DENILEUKIN DIFTITOX
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103767 0 1 251999 300 MCG2 ML ( 150 MCGML ) 01302014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No ELI LILLY AND CO 1611
Trade Name XIGRIS
Proper Name DROTRECOGIN ALFA (ACTIVATED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125029 0 1 11212001 5 MGVIAL ( 5 MGVIAL ) 10262011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125029 0 2 11212001 20 MGVIAL ( 20 MGVIAL ) 10102011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GENENTECH INC 1048
Trade Name RAPTIVA
Proper Name EFALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125075 0 1 10272003 125 MGVIAL ( 125 MGVIAL ) 09012009
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
March 2018 Page 3 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103976 0 2 6202003 125 MGVIAL ( 125 MGVIAL ) 08252016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103948 0 3 572001 10 MGVIAL ( 10 MGVIAL ) 07062011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name MYOZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125141 0 1 4282006 50 MGVIAL ( 50 MGVIAL ) 10172014
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name BEXXAR THERAPEUTIC REGIME
Proper Name TOSITUMOMAB AND IODINE I-131 TOSITUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125011 0 1 6272003 01 MGML I-131 TOSITUMOMAB ( 01 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 2 6272003 11 MGML I-131 TOSITUMOMAB ( 11 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 3 6272003 14 MGML TOSITUMOMAB ( 14 MGML 03102014 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 4 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No HEMISPHERX BIOPHARMA INC 1703
Trade Name ALFERON N INJECTION
Proper Name INTERFERON ALFA-N3 (HUMAN LEUKOCYTE DERIVED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103158 0 1 10101989 5 MIUVIAL ( 5 MIUVIAL ) 06272013
SOLUTION INTRALESIONAL MULTI-DOSE VIAL
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name ROFERON A
Proper Name INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103145 0 1 641986 3 MIU05 ML ( 3 MIU05 ML ) 06012009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name ZENAPAX
Proper Name DACLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103749 0 1 12101997 25 MG5 ML ( 25 MG5 ML ) 07072011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No KADMON PHARMACEUTICALS LLC 1867
Trade Name INFERGEN
Proper Name INTERFERON ALFACON-1
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103663 0 1 1061997 9 MCG03 ML ( 30 MCGML ) 07252013
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 5 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103770 0 3 6191998 50 MGVIAL ( 50 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
103770 0 4 6191998 100 MGVIAL ( 100 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name INTRON A
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103132 0 6 641986 10 MIUML ( 10 MIUML ) 09232013
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103132 0 7 641986 225 MIU15 ML ( 225 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 8 641986 375 MIU15 ML ( 375 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 9 641986 75 MIU15 ML ( 75 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103949 0 5 1192001 675 MCGPEN ( 675 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 6 1192001 108 MCGPEN ( 108 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
March 2018 Page 6 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name PEGINTRON
103949 0 7 1192001 1184 MCGVIAL ( 1184 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 8 1192001 162 MCGPEN ( 162 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 9 1192001 1776 MCGVIAL ( 1776 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 10 1192001 2025 MCGPEN ( 2025 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 11 1192001 222 MCGVIAL ( 222 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No PALATIN TECHNOLOGIES INC 1588
Trade Name NEUTROSPEC TECHNETIUM (99M TC)
Proper Name FANOLESOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103928 0 1 722004 025 MGVIAL ( 025 MGVIAL ) 09222008
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No RECORDATI RARE DISEASES INC 1899
Trade Name ELSPAR
Proper Name ASPARAGINASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
101063 0 1 1101978 10000 IU ( 10000 IUVIAL ) 04092014
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
March 2018 Page 7 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No SCHERING CORP 0994
Trade Name PEGINTRONREBETOL COMBO PACK
Proper Name PEGINTERFERON ALFA-2B AND RIBAVIRIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125196 0 1 6132008 ( 4 (120 MCG05ML) REDIPEN amp 140 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 2 6132008 ( 4 (150 MCG05ML) REDIPEN amp 168 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 3 6132008 ( 4 (150 MCG05ML) REDIPEN amp 196 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 4 6132008 ( 4 (50 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 5 6132008 ( 4 (80 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125422 0 2 10172012 05 MG ( 25 MGML ) 08082017
SOLUTION INTRAVETREAL SINGLE-DOSE VIAL
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125164 0 10 11142007 50 MCGML ( 50 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 8 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
125164 0 11 11142007 100 MCGML ( 100 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 12 11142007 200 MCGML ( 200 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 13 11142007 300 MCGML ( 300 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 14 11142007 400 MCGML ( 400 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 15 11142007 400 MCG06 ML ( 400 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 16 11142007 600 MCGML ( 600 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 17 11142007 600 MCG06 ML ( 600 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 18 11142007 800 MCG06 ML ( 800 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 19 11142007 1000 MCGML ( 1000 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 9 of 9
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name CATHFLO ACTIVASE
Proper Name ALTEPLASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103172 0 1 11131987
POWDER INTRACATHETER SINGLE-DOSE VIAL
2 MG ( 2 MGVIAL )
Trade Name
Proper Name
BLASTN
125486 0
GAZYVA
OBINUYUZUMAB
Approval Date Product
1112013 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1000 MG40 ML ( 25 MGML )
Trade Name
Proper Name
BLASTN
761083 0
HEMLIBRA
EMICIZUMAB-KXWH
Approval Date Product
11162017 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML )
761083 0 2 11162017
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
60 MG04 ML ( 150 MGML )
761083 0 3 11162017
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
105 MG07 ML ( 150 MGML )
761083 0 4 11162017
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
150 MGML ( 150 MGML )
Trade Name
Proper Name
BLASTN
103792 0
HERCEPTIN
TRASTUZUMAB
Approval Date Product
9251998 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS MULTI-DOSE VIAL
420 MG ( 420 MGVIAL )
March 2018 Page 19 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
103792 5336 2 2102017 150 MG ( 150 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name KADCYLA
Proper Name ADO-TRASIUZUMAB EMTANSINE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125427 0 1 2222013
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
125427 0 2 2222013
POWDER INTRAVENOUS SINGLE-DOSE VIAL
160 MG ( 160 MGVIAL )
Trade Name
Proper Name
LUCENTIS
RANIBIZUMAB
BLASTN
125156 0
Product
1
Approval Date
6302006
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE
05 MG005 ML ( 10 MGML )
Proper Name RANIDIZUMAB
BLASTN
125156 076
Product
2
Approval Date
8102012
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE
03 MG005 ML ( 6 MGML )
Trade Name
Proper Name
OCREVUS
OCRELIZUMAB
BLASTN
761053 0
Product
1
Approval Date
3282017
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
300 MG10 ML ( 30 MGML )
Trade Name
Proper Name
PERJETA
PERTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 20 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
125409 0 1 682012 420 MG14 ML ( 30 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name PULMOZYME
Proper Name DORNASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103532 0 1 12301993 25 MG25 ML ( 1 MGML )
SOLUTION INHALATION AMPULE
Trade Name RITUXAN
Proper Name RITUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103705 0 1 11261997 100 MG10 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
103705 0 2 11261997 500 MG50 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name RITUXAN HYCELA
Proper Name RITUXIMAB AND HYALURONIDASE HUMAN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761064 0 1 6222017 1400 MG AND 23400 U117 ML ( 11966 MG AND 2000 UML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
761064 0 2 6222017 1600 MG AND 26800 U134 ML ( 11966 MG AND 2000 UML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name TECENTRIQ
Proper Name ATEZOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761034 0 1 582016 1200 MG20 ML ( 60 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name TNKASE
March 2018 Page 21 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Proper Name TENECTEPLASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103909 0 1 622000 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103976 0 1 6202003 150 MG ( 150 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103948 0 1 572001
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML )
Trade Name
Proper Name
FABRAZYME
AGALSIDASE BETA
BLASTN
103979 0
Product
1
Approval Date
4242003
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
5 MG ( 5 MGVIAL )
103979 0 2 4242003
POWDER INTRAVENOUS SINGLE-DOSE VIAL
35 MG ( 35 MGVIAL )
Trade Name
Proper Name
LEMTRADA
ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 22 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENZYME CORP 1596
103948 5139 2 11142014 12 MG12 ML ( 10MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name LUMIZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125291 0 1 5242010 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name NUCALA
Proper Name MEPOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125526 0 1 11142015
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
TANZEUM
ALBIGLUTIDE
BLASTN
125431 0
Product
1
Approval Date
4152014
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS AUTOINJECTOR
30 MG ( 30 MGAUTOINJECTOR )
125431 0 2 4152014
POWDER SUBCUTANEOUS AUTOINJECTOR
50 MG ( 50 MGAUTOINJECTOR )
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name PEGASYS
Proper Name PEGINTERFERON ALFA 2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103964 5204 4 9292011 180 MCG05 ML ( 360 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 23 of 42
CDER Billable Biologic Product List
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Proper Name PEG-INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103964 0 1 10162002 180 MCGML ( 180 MCGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
103964 0 2 10162002 180 MCG05 ML ( 360 MCGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
103964 5204 3 9292011 135 MCG05 ML ( 270 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
ApplicantLicense No HORIZON PHARMA IRELAND LTD 2022
Trade Name ACTIMMUNE
Proper Name INTERFERON GAMMA-1B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103836 0 1 2251999 100 MCG05 ML ( 200 MCGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No HORIZON PHARMA RHEUMATOLOGY LLC 1998
Trade Name KRYSTEXXA
Proper Name PEGLOTICASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125293 0 1 9142010 8MGML ( 8MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 24 of 42
CDER Billable Biologic Product List
ApplicantLicense No HUMAN GENOME SCIENCES INC 1820
Trade Name BENLYSTA
Proper Name BELIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125370 0 1 392011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
120 MG ( 120 MGVIAL )
125370 0 2 392011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
400 MG ( 400 MGVIAL )
125370 0 3 392011
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )
125370 0 4 392011
SOLUTION SUBCUTANEOUS AUTOINJECTOR
200 MGML ( 200 MGML )
BLASTN
761043 0
Product
1
Approval Date
7202017
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )
Trade Name
Proper Name
RAXIBACUMAB
RAXIBACUMAB
BLASTN
125349 0
Product
1
Approval Date
12142012
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1700 MG34 ML ( 50 MGML )
ApplicantLicense No IMCLONE LLC 1695
Trade Name ERBITUX
Proper Name CETUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125084 0 1 2122004 100 MG50 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 25 of 42
CDER Billable Biologic Product List
ApplicantLicense No IMCLONE LLC 1695
125084 0 2 2122004 200 MG100 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No IMMUNEX CORP 1132
Trade Name ENBREL
Proper Name ETANERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103795 0 1 1121998
POWDER SUBCUTANEOUS MULTI-DOSE VIAL
25 MG ( 25 MGVIAL )
103795 5184 2 9272004
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
50 MGML ( 50 MGML )
103795 0 3 9272004
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MGML ( 50 MGML )
103795 5184 4 9272004
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
25 MG05 ML ( 50 MGML )
103795 5556 5 9142017
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MGML ( 50 MGML )
ApplicantLicense No IPSEN BIOPHARM LIMITED 1787
Trade Name DYSPORT
Proper Name ABOBOTULINUMTOXINA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125274 0 1 4292009
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
300 UNITS ( 300 UNITSVIAL )
125274 0 2 4292009
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
500 UNITS ( 500 UNITSVIAL )
March 2018 Page 26 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
Trade Name DARZALEX
Proper Name DARATUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761036 0 1 11162015
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG5 ML ( 20 MGML )
761036 0 2 11162015
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
400 MG20 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
103772 0
REMICADE
INFLIXIMAB
Approval Date Product
8241998 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
BLASTN
103575 0
REOPRO
ABCIXIMAB
Approval Date Product
12221994 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
10 MG5 ML ( 2 MGML )
Trade Name
Proper Name
BLASTN
125289 0
SIMPONI
GOLIMUMAB
Approval Date Product
4242009 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
50 MG05 ML ( 100 MGML )
125289 0 2 4242009
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MG05 ML ( 100 MGML )
125289 0 3 4242009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
100 MGML ( 100 MGML )
March 2018 Page 27 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
125289 0 4 4242009 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name SIMPONI ARIA
Proper Name GOLIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125433 0 1 7182013 50 MG4 ML ( 125 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name STELARA
Proper Name USTEKINUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125261 0 1 9252009 90 MGML ( 90 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125261 0 2 9252009 45 MG05 ML ( 90 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL amp PREFILLED SYRINGE
125261 0 3 9252009 130 MG26 ML ( 5 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761044 0 1 9232016 130 MG26 ML ( 5 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SYLVANT
Proper Name SILTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125496 0 1 4232014 100 MG ( 100 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125496 0 2 4232014 400 MG ( 400 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 28 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
Trade Name TREMFYA
Proper Name GUSELKUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761061 0 1 7132017 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No JAZZ PHARMACEUTICALS INC 1901
Trade Name ERWINAZE
Proper Name ASPARAGINASE ERWINIA CHRYSANTHEMI
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
105359 0 1 11182011 10000 IU ( 10000 IUVIAL )
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103770 0 1 6191998
SOLUTION INTRAMUSCULAR
50 MG05 ML ( 100 MGML )
SINGLE-DOSE VIAL
103770 0 2 6191998
SOLUTION INTRAMUSCULAR
100 MGML ( 100 MGML )
SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name ILUMYA
Proper Name TILDRAKIZUMAB-ASMN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761067 0 1 3202018 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name INTRON A
March 2018 Page 29 of 42
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103132 0 1 641986 10 MIU ( 10 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL INTRAVENOUS SINGLE-DOSE VIAL
103132 0 2 641986 18 MIU ( 18 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL
103132 0 3 641986 50 MIU ( 50 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL
103132 0 4 641986 228 MIU38 ML ( 6 MIUML )
SOLUTION INTRAMUSCULAR SUBCUTANEOUS MULTI-DOSE VIAL
103132 0 5 641986 32 MIU32 ML ( 10 MIUML )
SOLUTION INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL MULTI-DOSE VIAL
Trade Name KEYTRUDA
Proper Name PEMBROLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125514 0 1 942014 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125514 1 2 1152015 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 0 1 1192001 74 MCG ( 74 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SYLATRON
Proper Name PEGINTERFERON ALFA-2B
March 2018 Page 30 of 42
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 5153 2 3292011 296 MCG ( 296 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 3 3292011 444 MCG ( 444 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 4 3292011 888 MCG ( 888 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name ZINPLAVA
Proper Name BEZLOTOXUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761046 0 1 10212016 1000 MG40 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No MERZ PHARMACEUTICALS GMBH 1830
Trade Name XEOMIN
Proper Name INCOBOTULINUMTOXINA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125360 0 1 7302010
POWDER INTRAMUSCULAR
50 U ( 50 UVIAL )
SINGLE-DOSE VIAL
125360 0 2 7302010
POWDER INTRAMUSCULAR
100 U ( 100 UVIAL )
SINGLE-DOSE VIAL
125360 3 3 11202015
POWDER INTRAMUSCULAR
200 U ( 200 UVIAL )
SINGLE-DOSE VIAL
March 2018 Page 31 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
Trade Name ARZERRA
Proper Name OFATUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125326 0 1 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG5 ML ( 20 MGML )
125326 0 2 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1000 MG50 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
125504 0
COSENTYX
SECUKINUMAB
Approval Date Product
1212015 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
150 MG ( 150 MGVIAL )
125504 0 2 1212015
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MGML ( 150 MGML )
125504 0 3 1212015
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MGML ( 150 MGML )
Trade Name
Proper Name
BLASTN
125290 0
EXTAVIA
INTERFERON BETA-1B
Approval Date Product
8142009 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
03 MG ( 03 MGVIAL )
Trade Name
Proper Name
BLASTN
125319 0
ILARIS
CANAKINUMAB
Approval Date Product
6172009 1
PotencyDosage FormRoutePresentation
180 MGVIAL ( 180 MGVIAL )
March 2018 Page 32 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
125319 88 2 12222016 150 MG ( 150 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
125319 0 3 12222016 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SIMULECT
Proper Name BASILIXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103764 0 1 5121998 10 MG ( 10 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
103764 0 2 5121998 20 MG ( 20 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No NPS PHARMACEUTICALS INC 1908
Trade Name NATPARA
Proper Name PARATHYROID HORMONE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 33 of 42
CDER Billable Biologic Product List
ApplicantLicense No PROMETHEUS LABORATORIES INC 1848
Trade Name PROLEUKIN
Proper Name ALDESLEUKIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103293 0 1 551992 22 MIU ( 22 MIUVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760
Trade Name ARCALYST
Proper Name RILONACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125249 0 1 2272008
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
220MG ( 220MGVIAL )
Trade Name
Proper Name
DUPIXENT
DUPILUMAB
BLASTN
761055 0
Product
1
Approval Date
3282017
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
300 MG2 ML ( 150 MGML )
Trade Name
Proper Name
EYLEA
AFLIBERCEPT
BLASTN
125387 0
Product
1
Approval Date
11182011
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
2 MG005 ML ( 40 MGML )
March 2018 Page 34 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Trade Name ELITEK
Proper Name RASBURICASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103946 0 1 7122002
POWDER INTRAVENOUS SINGLE-DOSE VIAL
15 MG ( 15 MGVIAL )
103946 5020 2 162006
POWDER INTRAVENOUS SINGLE-DOSE VIAL
75 MG ( 75 MGVIAL )
Trade Name
Proper Name
BLASTN
761037 0
KEVZARA
SARILUMAB
Approval Date Product
5222017 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MG114 ML ( 13158 MGML )
761037 0 2 5222017
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MG114 ML ( 17544 MGML )
761037 1 3 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MG114 ML ( 13158 MGML )
761037 1 4 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
200 MG114 ML ( 17544 MGML )
Trade Name
Proper Name
BLASTN
103362 0
LEUKINE
SARGRAMOSTIM
Approval Date Product
351991 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
250 MCG ( 250 MCGVIAL )
103362 0 2 351991
SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL
500 MCGML ( 500 MCGML )
Trade Name PRALUENT
March 2018 Page 35 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Proper Name ALIROCUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125559 0 1 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 2 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 3 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125559 0 4 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name ZALTRAP
Proper Name ZIV-AFLIBERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125418 0 1 832012 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125418 0 2 832012 200 MG8 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SEATTLE GENETICS INC 1853
Trade Name ADCETRIS
Proper Name BRENTUXIMAB VEDOTIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125388 1 1 8192011 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 36 of 42
CDER Billable Biologic Product List
ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593
Trade Name ELAPRASE
Proper Name IDURSULFASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125151 0 1 7242006 6 MG3 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SICOR BIOTECH UAB 1803
Trade Name GRANIX
Proper Name TBO-FILGRASTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125294 0 1 8292012
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
300 MCG0 5 ML ( 600 MCGML )
125294 0 2 8292012
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
480 MCG08 ML ( 600 MCGML )
ApplicantLicense No SMITH AND NEPHEW INC 2004
Trade Name REGRANEX
Proper Name BECAPLERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103691 0 1 12161997
GEL TOPICAL
100 UG ( 100 UGGM )
Trade Name
Proper Name
SANTYL
COLLAGENASE
BLASTN
101995 0
Product
1
Approval Date
641965
PotencyDosage FormRoutePresentation
OINTMENT TOPICAL
30 G amp 90 G TUBE ( 250 UGRAM )
March 2018 Page 37 of 42
CDER Billable Biologic Product List
ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718
Trade Name MYOBLOC
Proper Name RIMABOTULINUM TOXIN B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103846 0 1 1282002
SOLUTION INTRAMUSCULAR
2500 IU05 ML ( 5000 IUML )
SINGLE-DOSE VIAL
103846 0 3 1282002
SOLUTION INTRAMUSCULAR
10000 IU2 ML ( 5000 IUML )
SINGLE-DOSE VIAL
Proper Name RIMABOTULINUMTOXINB
BLASTN
103846 0
Product
2
Approval Date
1282002
PotencyDosage FormRoutePresentation
SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL
5000 IUML ( 5000 IUML )
ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832
Trade Name ZEVALIN
Proper Name IBRITUMOMAB TIUXETAN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125019 0 1 2192002 32 MG2 ML ( 16 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
Trade Name KEPIVANCE
Proper Name PALIFERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125103 0 1 12152004 625 MG ( 625 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name KINERET
Proper Name ANAKINRA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 38 of 42
CDER Billable Biologic Product List
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898
Trade Name ENTYVIO
Proper Name VEDOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125476 0 1 5202014 300 MG ( 300 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No TEVA RESPIRATORY LLC 2047
Trade Name CINQAIR
Proper Name RESLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761033 0 1 3232016 100 MG10 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No THERATECHNOLOGIES INC 2091
Trade Name TROGARZO
Proper Name IBALIZUMAB-UIYK
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761065 0 1 362018 200 MG133 ML ( 150 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 39 of 42
CDER Billable Biologic Product List
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
0375 MG03 ML ( 125 MGML )2222017 125422 038 1
ApplicantLicense No UCB INC 1736
Trade Name CIMZIA
Proper Name CERTOLIZUMAB PEGOL
BLASTN Approval Date PotencyDosage FormRoutePresentation Product
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
200 MG ( 200 MGVIAL ) 4222008 125160 0 1
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )5132009 125160 080 2
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
Trade Name CRYSVITA
Proper Name BUROSUMAB-TWZA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761068 0 1 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
10 MGML ( 10 MGML )
761068 0 2 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
20 MGML ( 20 MGML )
761068 0
Trade Name
Proper Name
BLASTN
March 2018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML ) 4172018 3
MEPSEVII
VESTRONIDASE ALFA-VJBK
Approval Date PotencyDosage FormRoutePresentation Product
Page 40 of 42
CDER Billable Biologic Product List
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
761047 0 1 11152017 10 MG5 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No UNITED THERAPEUTICS CORP 1993
Trade Name UNITUXIN
Proper Name DINUTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125516 0 1 3102015 175 MG5 ML ( 35 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053
Trade Name SILIQ
Proper Name BRODALUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761032 0 1 2152017 210 MG15 ML ( 140 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 41 of 42
CDER Billable Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No WYETH PHARMACEUTICALS INC 0003
Trade Name BESPONSA
Proper Name INOTUZUMAB OZOGAMICIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761040 0 1 8172017 09 MG ( 09 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 42 of 42
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 1 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
9172001 103951 0 26
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
200 MCGML ( 200 MCGML ) 09272012
103951 0 27 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
200 MCG04 ML ( 500 MCGML ) 09272012
103951 0 28 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
300 MCGML ( 300 MCGML ) 09272012
103951 0 29 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
300 MCG06 ML ( 500 MCGML ) 09272012
103951 0 30 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
500 MCGML ( 500 MCGML ) 09272012
ApplicantLicense No ASTELLAS PHARMACEUTICALS US INC 1748
Trade Name AMEVIVE
Proper Name ALEFACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125036 0 1 1302003 75 MGVIAL ( 75 MGVIAL ) 09242008
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
125036 0 2 1302003 15 MGVIAL ( 15 MGVIAL ) 09282012
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No BOEHRINGER INGELHEIM PHARMA KG 1251
Trade Name VERLUMA
Proper Name NOFETUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103769 0 1 10131998 10 MGML ( 10 MGML ) 08132013
INTRAVENOUS
March 2018 Page 2 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No CENTOCOR ORTHO BIOTECH PRODUCTS LP 1824
Trade Name ORTHOCLONE OKT3
Proper Name MUROMONAB-CD3
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103463 0 1 9141992 1 MGML ( 1 MGML ) 01112012
SOLUTION INTRAVENOUS AMPULE
ApplicantLicense No EISAI INCORPORATED 1862
Trade Name ONTAK
Proper Name DENILEUKIN DIFTITOX
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103767 0 1 251999 300 MCG2 ML ( 150 MCGML ) 01302014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No ELI LILLY AND CO 1611
Trade Name XIGRIS
Proper Name DROTRECOGIN ALFA (ACTIVATED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125029 0 1 11212001 5 MGVIAL ( 5 MGVIAL ) 10262011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125029 0 2 11212001 20 MGVIAL ( 20 MGVIAL ) 10102011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GENENTECH INC 1048
Trade Name RAPTIVA
Proper Name EFALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125075 0 1 10272003 125 MGVIAL ( 125 MGVIAL ) 09012009
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
March 2018 Page 3 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103976 0 2 6202003 125 MGVIAL ( 125 MGVIAL ) 08252016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103948 0 3 572001 10 MGVIAL ( 10 MGVIAL ) 07062011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name MYOZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125141 0 1 4282006 50 MGVIAL ( 50 MGVIAL ) 10172014
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name BEXXAR THERAPEUTIC REGIME
Proper Name TOSITUMOMAB AND IODINE I-131 TOSITUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125011 0 1 6272003 01 MGML I-131 TOSITUMOMAB ( 01 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 2 6272003 11 MGML I-131 TOSITUMOMAB ( 11 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 3 6272003 14 MGML TOSITUMOMAB ( 14 MGML 03102014 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 4 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No HEMISPHERX BIOPHARMA INC 1703
Trade Name ALFERON N INJECTION
Proper Name INTERFERON ALFA-N3 (HUMAN LEUKOCYTE DERIVED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103158 0 1 10101989 5 MIUVIAL ( 5 MIUVIAL ) 06272013
SOLUTION INTRALESIONAL MULTI-DOSE VIAL
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name ROFERON A
Proper Name INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103145 0 1 641986 3 MIU05 ML ( 3 MIU05 ML ) 06012009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name ZENAPAX
Proper Name DACLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103749 0 1 12101997 25 MG5 ML ( 25 MG5 ML ) 07072011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No KADMON PHARMACEUTICALS LLC 1867
Trade Name INFERGEN
Proper Name INTERFERON ALFACON-1
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103663 0 1 1061997 9 MCG03 ML ( 30 MCGML ) 07252013
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 5 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103770 0 3 6191998 50 MGVIAL ( 50 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
103770 0 4 6191998 100 MGVIAL ( 100 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name INTRON A
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103132 0 6 641986 10 MIUML ( 10 MIUML ) 09232013
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103132 0 7 641986 225 MIU15 ML ( 225 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 8 641986 375 MIU15 ML ( 375 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 9 641986 75 MIU15 ML ( 75 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103949 0 5 1192001 675 MCGPEN ( 675 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 6 1192001 108 MCGPEN ( 108 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
March 2018 Page 6 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name PEGINTRON
103949 0 7 1192001 1184 MCGVIAL ( 1184 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 8 1192001 162 MCGPEN ( 162 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 9 1192001 1776 MCGVIAL ( 1776 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 10 1192001 2025 MCGPEN ( 2025 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 11 1192001 222 MCGVIAL ( 222 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No PALATIN TECHNOLOGIES INC 1588
Trade Name NEUTROSPEC TECHNETIUM (99M TC)
Proper Name FANOLESOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103928 0 1 722004 025 MGVIAL ( 025 MGVIAL ) 09222008
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No RECORDATI RARE DISEASES INC 1899
Trade Name ELSPAR
Proper Name ASPARAGINASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
101063 0 1 1101978 10000 IU ( 10000 IUVIAL ) 04092014
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
March 2018 Page 7 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No SCHERING CORP 0994
Trade Name PEGINTRONREBETOL COMBO PACK
Proper Name PEGINTERFERON ALFA-2B AND RIBAVIRIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125196 0 1 6132008 ( 4 (120 MCG05ML) REDIPEN amp 140 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 2 6132008 ( 4 (150 MCG05ML) REDIPEN amp 168 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 3 6132008 ( 4 (150 MCG05ML) REDIPEN amp 196 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 4 6132008 ( 4 (50 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 5 6132008 ( 4 (80 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125422 0 2 10172012 05 MG ( 25 MGML ) 08082017
SOLUTION INTRAVETREAL SINGLE-DOSE VIAL
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125164 0 10 11142007 50 MCGML ( 50 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 8 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
125164 0 11 11142007 100 MCGML ( 100 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 12 11142007 200 MCGML ( 200 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 13 11142007 300 MCGML ( 300 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 14 11142007 400 MCGML ( 400 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 15 11142007 400 MCG06 ML ( 400 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 16 11142007 600 MCGML ( 600 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 17 11142007 600 MCG06 ML ( 600 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 18 11142007 800 MCG06 ML ( 800 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 19 11142007 1000 MCGML ( 1000 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 9 of 9
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
103792 5336 2 2102017 150 MG ( 150 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name KADCYLA
Proper Name ADO-TRASIUZUMAB EMTANSINE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125427 0 1 2222013
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
125427 0 2 2222013
POWDER INTRAVENOUS SINGLE-DOSE VIAL
160 MG ( 160 MGVIAL )
Trade Name
Proper Name
LUCENTIS
RANIBIZUMAB
BLASTN
125156 0
Product
1
Approval Date
6302006
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE
05 MG005 ML ( 10 MGML )
Proper Name RANIDIZUMAB
BLASTN
125156 076
Product
2
Approval Date
8102012
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL amp PREFILLED SYRINGE
03 MG005 ML ( 6 MGML )
Trade Name
Proper Name
OCREVUS
OCRELIZUMAB
BLASTN
761053 0
Product
1
Approval Date
3282017
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
300 MG10 ML ( 30 MGML )
Trade Name
Proper Name
PERJETA
PERTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 20 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
125409 0 1 682012 420 MG14 ML ( 30 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name PULMOZYME
Proper Name DORNASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103532 0 1 12301993 25 MG25 ML ( 1 MGML )
SOLUTION INHALATION AMPULE
Trade Name RITUXAN
Proper Name RITUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103705 0 1 11261997 100 MG10 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
103705 0 2 11261997 500 MG50 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name RITUXAN HYCELA
Proper Name RITUXIMAB AND HYALURONIDASE HUMAN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761064 0 1 6222017 1400 MG AND 23400 U117 ML ( 11966 MG AND 2000 UML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
761064 0 2 6222017 1600 MG AND 26800 U134 ML ( 11966 MG AND 2000 UML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name TECENTRIQ
Proper Name ATEZOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761034 0 1 582016 1200 MG20 ML ( 60 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name TNKASE
March 2018 Page 21 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Proper Name TENECTEPLASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103909 0 1 622000 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103976 0 1 6202003 150 MG ( 150 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103948 0 1 572001
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML )
Trade Name
Proper Name
FABRAZYME
AGALSIDASE BETA
BLASTN
103979 0
Product
1
Approval Date
4242003
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
5 MG ( 5 MGVIAL )
103979 0 2 4242003
POWDER INTRAVENOUS SINGLE-DOSE VIAL
35 MG ( 35 MGVIAL )
Trade Name
Proper Name
LEMTRADA
ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 22 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENZYME CORP 1596
103948 5139 2 11142014 12 MG12 ML ( 10MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name LUMIZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125291 0 1 5242010 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name NUCALA
Proper Name MEPOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125526 0 1 11142015
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
TANZEUM
ALBIGLUTIDE
BLASTN
125431 0
Product
1
Approval Date
4152014
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS AUTOINJECTOR
30 MG ( 30 MGAUTOINJECTOR )
125431 0 2 4152014
POWDER SUBCUTANEOUS AUTOINJECTOR
50 MG ( 50 MGAUTOINJECTOR )
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name PEGASYS
Proper Name PEGINTERFERON ALFA 2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103964 5204 4 9292011 180 MCG05 ML ( 360 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 23 of 42
CDER Billable Biologic Product List
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Proper Name PEG-INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103964 0 1 10162002 180 MCGML ( 180 MCGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
103964 0 2 10162002 180 MCG05 ML ( 360 MCGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
103964 5204 3 9292011 135 MCG05 ML ( 270 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
ApplicantLicense No HORIZON PHARMA IRELAND LTD 2022
Trade Name ACTIMMUNE
Proper Name INTERFERON GAMMA-1B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103836 0 1 2251999 100 MCG05 ML ( 200 MCGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No HORIZON PHARMA RHEUMATOLOGY LLC 1998
Trade Name KRYSTEXXA
Proper Name PEGLOTICASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125293 0 1 9142010 8MGML ( 8MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 24 of 42
CDER Billable Biologic Product List
ApplicantLicense No HUMAN GENOME SCIENCES INC 1820
Trade Name BENLYSTA
Proper Name BELIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125370 0 1 392011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
120 MG ( 120 MGVIAL )
125370 0 2 392011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
400 MG ( 400 MGVIAL )
125370 0 3 392011
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )
125370 0 4 392011
SOLUTION SUBCUTANEOUS AUTOINJECTOR
200 MGML ( 200 MGML )
BLASTN
761043 0
Product
1
Approval Date
7202017
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )
Trade Name
Proper Name
RAXIBACUMAB
RAXIBACUMAB
BLASTN
125349 0
Product
1
Approval Date
12142012
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1700 MG34 ML ( 50 MGML )
ApplicantLicense No IMCLONE LLC 1695
Trade Name ERBITUX
Proper Name CETUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125084 0 1 2122004 100 MG50 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 25 of 42
CDER Billable Biologic Product List
ApplicantLicense No IMCLONE LLC 1695
125084 0 2 2122004 200 MG100 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No IMMUNEX CORP 1132
Trade Name ENBREL
Proper Name ETANERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103795 0 1 1121998
POWDER SUBCUTANEOUS MULTI-DOSE VIAL
25 MG ( 25 MGVIAL )
103795 5184 2 9272004
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
50 MGML ( 50 MGML )
103795 0 3 9272004
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MGML ( 50 MGML )
103795 5184 4 9272004
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
25 MG05 ML ( 50 MGML )
103795 5556 5 9142017
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MGML ( 50 MGML )
ApplicantLicense No IPSEN BIOPHARM LIMITED 1787
Trade Name DYSPORT
Proper Name ABOBOTULINUMTOXINA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125274 0 1 4292009
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
300 UNITS ( 300 UNITSVIAL )
125274 0 2 4292009
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
500 UNITS ( 500 UNITSVIAL )
March 2018 Page 26 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
Trade Name DARZALEX
Proper Name DARATUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761036 0 1 11162015
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG5 ML ( 20 MGML )
761036 0 2 11162015
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
400 MG20 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
103772 0
REMICADE
INFLIXIMAB
Approval Date Product
8241998 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
BLASTN
103575 0
REOPRO
ABCIXIMAB
Approval Date Product
12221994 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
10 MG5 ML ( 2 MGML )
Trade Name
Proper Name
BLASTN
125289 0
SIMPONI
GOLIMUMAB
Approval Date Product
4242009 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
50 MG05 ML ( 100 MGML )
125289 0 2 4242009
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MG05 ML ( 100 MGML )
125289 0 3 4242009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
100 MGML ( 100 MGML )
March 2018 Page 27 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
125289 0 4 4242009 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name SIMPONI ARIA
Proper Name GOLIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125433 0 1 7182013 50 MG4 ML ( 125 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name STELARA
Proper Name USTEKINUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125261 0 1 9252009 90 MGML ( 90 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125261 0 2 9252009 45 MG05 ML ( 90 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL amp PREFILLED SYRINGE
125261 0 3 9252009 130 MG26 ML ( 5 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761044 0 1 9232016 130 MG26 ML ( 5 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SYLVANT
Proper Name SILTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125496 0 1 4232014 100 MG ( 100 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125496 0 2 4232014 400 MG ( 400 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 28 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
Trade Name TREMFYA
Proper Name GUSELKUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761061 0 1 7132017 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No JAZZ PHARMACEUTICALS INC 1901
Trade Name ERWINAZE
Proper Name ASPARAGINASE ERWINIA CHRYSANTHEMI
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
105359 0 1 11182011 10000 IU ( 10000 IUVIAL )
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103770 0 1 6191998
SOLUTION INTRAMUSCULAR
50 MG05 ML ( 100 MGML )
SINGLE-DOSE VIAL
103770 0 2 6191998
SOLUTION INTRAMUSCULAR
100 MGML ( 100 MGML )
SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name ILUMYA
Proper Name TILDRAKIZUMAB-ASMN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761067 0 1 3202018 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name INTRON A
March 2018 Page 29 of 42
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103132 0 1 641986 10 MIU ( 10 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL INTRAVENOUS SINGLE-DOSE VIAL
103132 0 2 641986 18 MIU ( 18 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL
103132 0 3 641986 50 MIU ( 50 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL
103132 0 4 641986 228 MIU38 ML ( 6 MIUML )
SOLUTION INTRAMUSCULAR SUBCUTANEOUS MULTI-DOSE VIAL
103132 0 5 641986 32 MIU32 ML ( 10 MIUML )
SOLUTION INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL MULTI-DOSE VIAL
Trade Name KEYTRUDA
Proper Name PEMBROLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125514 0 1 942014 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125514 1 2 1152015 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 0 1 1192001 74 MCG ( 74 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SYLATRON
Proper Name PEGINTERFERON ALFA-2B
March 2018 Page 30 of 42
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 5153 2 3292011 296 MCG ( 296 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 3 3292011 444 MCG ( 444 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 4 3292011 888 MCG ( 888 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name ZINPLAVA
Proper Name BEZLOTOXUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761046 0 1 10212016 1000 MG40 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No MERZ PHARMACEUTICALS GMBH 1830
Trade Name XEOMIN
Proper Name INCOBOTULINUMTOXINA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125360 0 1 7302010
POWDER INTRAMUSCULAR
50 U ( 50 UVIAL )
SINGLE-DOSE VIAL
125360 0 2 7302010
POWDER INTRAMUSCULAR
100 U ( 100 UVIAL )
SINGLE-DOSE VIAL
125360 3 3 11202015
POWDER INTRAMUSCULAR
200 U ( 200 UVIAL )
SINGLE-DOSE VIAL
March 2018 Page 31 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
Trade Name ARZERRA
Proper Name OFATUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125326 0 1 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG5 ML ( 20 MGML )
125326 0 2 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1000 MG50 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
125504 0
COSENTYX
SECUKINUMAB
Approval Date Product
1212015 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
150 MG ( 150 MGVIAL )
125504 0 2 1212015
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MGML ( 150 MGML )
125504 0 3 1212015
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MGML ( 150 MGML )
Trade Name
Proper Name
BLASTN
125290 0
EXTAVIA
INTERFERON BETA-1B
Approval Date Product
8142009 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
03 MG ( 03 MGVIAL )
Trade Name
Proper Name
BLASTN
125319 0
ILARIS
CANAKINUMAB
Approval Date Product
6172009 1
PotencyDosage FormRoutePresentation
180 MGVIAL ( 180 MGVIAL )
March 2018 Page 32 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
125319 88 2 12222016 150 MG ( 150 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
125319 0 3 12222016 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SIMULECT
Proper Name BASILIXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103764 0 1 5121998 10 MG ( 10 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
103764 0 2 5121998 20 MG ( 20 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No NPS PHARMACEUTICALS INC 1908
Trade Name NATPARA
Proper Name PARATHYROID HORMONE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 33 of 42
CDER Billable Biologic Product List
ApplicantLicense No PROMETHEUS LABORATORIES INC 1848
Trade Name PROLEUKIN
Proper Name ALDESLEUKIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103293 0 1 551992 22 MIU ( 22 MIUVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760
Trade Name ARCALYST
Proper Name RILONACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125249 0 1 2272008
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
220MG ( 220MGVIAL )
Trade Name
Proper Name
DUPIXENT
DUPILUMAB
BLASTN
761055 0
Product
1
Approval Date
3282017
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
300 MG2 ML ( 150 MGML )
Trade Name
Proper Name
EYLEA
AFLIBERCEPT
BLASTN
125387 0
Product
1
Approval Date
11182011
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
2 MG005 ML ( 40 MGML )
March 2018 Page 34 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Trade Name ELITEK
Proper Name RASBURICASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103946 0 1 7122002
POWDER INTRAVENOUS SINGLE-DOSE VIAL
15 MG ( 15 MGVIAL )
103946 5020 2 162006
POWDER INTRAVENOUS SINGLE-DOSE VIAL
75 MG ( 75 MGVIAL )
Trade Name
Proper Name
BLASTN
761037 0
KEVZARA
SARILUMAB
Approval Date Product
5222017 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MG114 ML ( 13158 MGML )
761037 0 2 5222017
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MG114 ML ( 17544 MGML )
761037 1 3 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MG114 ML ( 13158 MGML )
761037 1 4 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
200 MG114 ML ( 17544 MGML )
Trade Name
Proper Name
BLASTN
103362 0
LEUKINE
SARGRAMOSTIM
Approval Date Product
351991 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
250 MCG ( 250 MCGVIAL )
103362 0 2 351991
SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL
500 MCGML ( 500 MCGML )
Trade Name PRALUENT
March 2018 Page 35 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Proper Name ALIROCUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125559 0 1 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 2 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 3 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125559 0 4 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name ZALTRAP
Proper Name ZIV-AFLIBERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125418 0 1 832012 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125418 0 2 832012 200 MG8 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SEATTLE GENETICS INC 1853
Trade Name ADCETRIS
Proper Name BRENTUXIMAB VEDOTIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125388 1 1 8192011 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 36 of 42
CDER Billable Biologic Product List
ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593
Trade Name ELAPRASE
Proper Name IDURSULFASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125151 0 1 7242006 6 MG3 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SICOR BIOTECH UAB 1803
Trade Name GRANIX
Proper Name TBO-FILGRASTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125294 0 1 8292012
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
300 MCG0 5 ML ( 600 MCGML )
125294 0 2 8292012
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
480 MCG08 ML ( 600 MCGML )
ApplicantLicense No SMITH AND NEPHEW INC 2004
Trade Name REGRANEX
Proper Name BECAPLERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103691 0 1 12161997
GEL TOPICAL
100 UG ( 100 UGGM )
Trade Name
Proper Name
SANTYL
COLLAGENASE
BLASTN
101995 0
Product
1
Approval Date
641965
PotencyDosage FormRoutePresentation
OINTMENT TOPICAL
30 G amp 90 G TUBE ( 250 UGRAM )
March 2018 Page 37 of 42
CDER Billable Biologic Product List
ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718
Trade Name MYOBLOC
Proper Name RIMABOTULINUM TOXIN B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103846 0 1 1282002
SOLUTION INTRAMUSCULAR
2500 IU05 ML ( 5000 IUML )
SINGLE-DOSE VIAL
103846 0 3 1282002
SOLUTION INTRAMUSCULAR
10000 IU2 ML ( 5000 IUML )
SINGLE-DOSE VIAL
Proper Name RIMABOTULINUMTOXINB
BLASTN
103846 0
Product
2
Approval Date
1282002
PotencyDosage FormRoutePresentation
SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL
5000 IUML ( 5000 IUML )
ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832
Trade Name ZEVALIN
Proper Name IBRITUMOMAB TIUXETAN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125019 0 1 2192002 32 MG2 ML ( 16 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
Trade Name KEPIVANCE
Proper Name PALIFERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125103 0 1 12152004 625 MG ( 625 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name KINERET
Proper Name ANAKINRA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 38 of 42
CDER Billable Biologic Product List
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898
Trade Name ENTYVIO
Proper Name VEDOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125476 0 1 5202014 300 MG ( 300 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No TEVA RESPIRATORY LLC 2047
Trade Name CINQAIR
Proper Name RESLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761033 0 1 3232016 100 MG10 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No THERATECHNOLOGIES INC 2091
Trade Name TROGARZO
Proper Name IBALIZUMAB-UIYK
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761065 0 1 362018 200 MG133 ML ( 150 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 39 of 42
CDER Billable Biologic Product List
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
0375 MG03 ML ( 125 MGML )2222017 125422 038 1
ApplicantLicense No UCB INC 1736
Trade Name CIMZIA
Proper Name CERTOLIZUMAB PEGOL
BLASTN Approval Date PotencyDosage FormRoutePresentation Product
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
200 MG ( 200 MGVIAL ) 4222008 125160 0 1
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )5132009 125160 080 2
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
Trade Name CRYSVITA
Proper Name BUROSUMAB-TWZA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761068 0 1 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
10 MGML ( 10 MGML )
761068 0 2 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
20 MGML ( 20 MGML )
761068 0
Trade Name
Proper Name
BLASTN
March 2018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML ) 4172018 3
MEPSEVII
VESTRONIDASE ALFA-VJBK
Approval Date PotencyDosage FormRoutePresentation Product
Page 40 of 42
CDER Billable Biologic Product List
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
761047 0 1 11152017 10 MG5 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No UNITED THERAPEUTICS CORP 1993
Trade Name UNITUXIN
Proper Name DINUTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125516 0 1 3102015 175 MG5 ML ( 35 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053
Trade Name SILIQ
Proper Name BRODALUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761032 0 1 2152017 210 MG15 ML ( 140 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 41 of 42
CDER Billable Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No WYETH PHARMACEUTICALS INC 0003
Trade Name BESPONSA
Proper Name INOTUZUMAB OZOGAMICIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761040 0 1 8172017 09 MG ( 09 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 42 of 42
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 1 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
9172001 103951 0 26
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
200 MCGML ( 200 MCGML ) 09272012
103951 0 27 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
200 MCG04 ML ( 500 MCGML ) 09272012
103951 0 28 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
300 MCGML ( 300 MCGML ) 09272012
103951 0 29 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
300 MCG06 ML ( 500 MCGML ) 09272012
103951 0 30 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
500 MCGML ( 500 MCGML ) 09272012
ApplicantLicense No ASTELLAS PHARMACEUTICALS US INC 1748
Trade Name AMEVIVE
Proper Name ALEFACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125036 0 1 1302003 75 MGVIAL ( 75 MGVIAL ) 09242008
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
125036 0 2 1302003 15 MGVIAL ( 15 MGVIAL ) 09282012
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No BOEHRINGER INGELHEIM PHARMA KG 1251
Trade Name VERLUMA
Proper Name NOFETUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103769 0 1 10131998 10 MGML ( 10 MGML ) 08132013
INTRAVENOUS
March 2018 Page 2 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No CENTOCOR ORTHO BIOTECH PRODUCTS LP 1824
Trade Name ORTHOCLONE OKT3
Proper Name MUROMONAB-CD3
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103463 0 1 9141992 1 MGML ( 1 MGML ) 01112012
SOLUTION INTRAVENOUS AMPULE
ApplicantLicense No EISAI INCORPORATED 1862
Trade Name ONTAK
Proper Name DENILEUKIN DIFTITOX
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103767 0 1 251999 300 MCG2 ML ( 150 MCGML ) 01302014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No ELI LILLY AND CO 1611
Trade Name XIGRIS
Proper Name DROTRECOGIN ALFA (ACTIVATED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125029 0 1 11212001 5 MGVIAL ( 5 MGVIAL ) 10262011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125029 0 2 11212001 20 MGVIAL ( 20 MGVIAL ) 10102011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GENENTECH INC 1048
Trade Name RAPTIVA
Proper Name EFALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125075 0 1 10272003 125 MGVIAL ( 125 MGVIAL ) 09012009
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
March 2018 Page 3 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103976 0 2 6202003 125 MGVIAL ( 125 MGVIAL ) 08252016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103948 0 3 572001 10 MGVIAL ( 10 MGVIAL ) 07062011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name MYOZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125141 0 1 4282006 50 MGVIAL ( 50 MGVIAL ) 10172014
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name BEXXAR THERAPEUTIC REGIME
Proper Name TOSITUMOMAB AND IODINE I-131 TOSITUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125011 0 1 6272003 01 MGML I-131 TOSITUMOMAB ( 01 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 2 6272003 11 MGML I-131 TOSITUMOMAB ( 11 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 3 6272003 14 MGML TOSITUMOMAB ( 14 MGML 03102014 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 4 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No HEMISPHERX BIOPHARMA INC 1703
Trade Name ALFERON N INJECTION
Proper Name INTERFERON ALFA-N3 (HUMAN LEUKOCYTE DERIVED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103158 0 1 10101989 5 MIUVIAL ( 5 MIUVIAL ) 06272013
SOLUTION INTRALESIONAL MULTI-DOSE VIAL
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name ROFERON A
Proper Name INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103145 0 1 641986 3 MIU05 ML ( 3 MIU05 ML ) 06012009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name ZENAPAX
Proper Name DACLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103749 0 1 12101997 25 MG5 ML ( 25 MG5 ML ) 07072011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No KADMON PHARMACEUTICALS LLC 1867
Trade Name INFERGEN
Proper Name INTERFERON ALFACON-1
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103663 0 1 1061997 9 MCG03 ML ( 30 MCGML ) 07252013
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 5 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103770 0 3 6191998 50 MGVIAL ( 50 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
103770 0 4 6191998 100 MGVIAL ( 100 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name INTRON A
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103132 0 6 641986 10 MIUML ( 10 MIUML ) 09232013
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103132 0 7 641986 225 MIU15 ML ( 225 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 8 641986 375 MIU15 ML ( 375 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 9 641986 75 MIU15 ML ( 75 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103949 0 5 1192001 675 MCGPEN ( 675 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 6 1192001 108 MCGPEN ( 108 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
March 2018 Page 6 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name PEGINTRON
103949 0 7 1192001 1184 MCGVIAL ( 1184 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 8 1192001 162 MCGPEN ( 162 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 9 1192001 1776 MCGVIAL ( 1776 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 10 1192001 2025 MCGPEN ( 2025 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 11 1192001 222 MCGVIAL ( 222 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No PALATIN TECHNOLOGIES INC 1588
Trade Name NEUTROSPEC TECHNETIUM (99M TC)
Proper Name FANOLESOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103928 0 1 722004 025 MGVIAL ( 025 MGVIAL ) 09222008
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No RECORDATI RARE DISEASES INC 1899
Trade Name ELSPAR
Proper Name ASPARAGINASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
101063 0 1 1101978 10000 IU ( 10000 IUVIAL ) 04092014
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
March 2018 Page 7 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No SCHERING CORP 0994
Trade Name PEGINTRONREBETOL COMBO PACK
Proper Name PEGINTERFERON ALFA-2B AND RIBAVIRIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125196 0 1 6132008 ( 4 (120 MCG05ML) REDIPEN amp 140 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 2 6132008 ( 4 (150 MCG05ML) REDIPEN amp 168 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 3 6132008 ( 4 (150 MCG05ML) REDIPEN amp 196 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 4 6132008 ( 4 (50 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 5 6132008 ( 4 (80 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125422 0 2 10172012 05 MG ( 25 MGML ) 08082017
SOLUTION INTRAVETREAL SINGLE-DOSE VIAL
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125164 0 10 11142007 50 MCGML ( 50 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 8 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
125164 0 11 11142007 100 MCGML ( 100 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 12 11142007 200 MCGML ( 200 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 13 11142007 300 MCGML ( 300 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 14 11142007 400 MCGML ( 400 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 15 11142007 400 MCG06 ML ( 400 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 16 11142007 600 MCGML ( 600 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 17 11142007 600 MCG06 ML ( 600 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 18 11142007 800 MCG06 ML ( 800 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 19 11142007 1000 MCGML ( 1000 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 9 of 9
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
125409 0 1 682012 420 MG14 ML ( 30 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name PULMOZYME
Proper Name DORNASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103532 0 1 12301993 25 MG25 ML ( 1 MGML )
SOLUTION INHALATION AMPULE
Trade Name RITUXAN
Proper Name RITUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103705 0 1 11261997 100 MG10 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
103705 0 2 11261997 500 MG50 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name RITUXAN HYCELA
Proper Name RITUXIMAB AND HYALURONIDASE HUMAN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761064 0 1 6222017 1400 MG AND 23400 U117 ML ( 11966 MG AND 2000 UML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
761064 0 2 6222017 1600 MG AND 26800 U134 ML ( 11966 MG AND 2000 UML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name TECENTRIQ
Proper Name ATEZOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761034 0 1 582016 1200 MG20 ML ( 60 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name TNKASE
March 2018 Page 21 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Proper Name TENECTEPLASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103909 0 1 622000 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103976 0 1 6202003 150 MG ( 150 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103948 0 1 572001
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML )
Trade Name
Proper Name
FABRAZYME
AGALSIDASE BETA
BLASTN
103979 0
Product
1
Approval Date
4242003
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
5 MG ( 5 MGVIAL )
103979 0 2 4242003
POWDER INTRAVENOUS SINGLE-DOSE VIAL
35 MG ( 35 MGVIAL )
Trade Name
Proper Name
LEMTRADA
ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 22 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENZYME CORP 1596
103948 5139 2 11142014 12 MG12 ML ( 10MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name LUMIZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125291 0 1 5242010 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name NUCALA
Proper Name MEPOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125526 0 1 11142015
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
TANZEUM
ALBIGLUTIDE
BLASTN
125431 0
Product
1
Approval Date
4152014
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS AUTOINJECTOR
30 MG ( 30 MGAUTOINJECTOR )
125431 0 2 4152014
POWDER SUBCUTANEOUS AUTOINJECTOR
50 MG ( 50 MGAUTOINJECTOR )
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name PEGASYS
Proper Name PEGINTERFERON ALFA 2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103964 5204 4 9292011 180 MCG05 ML ( 360 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 23 of 42
CDER Billable Biologic Product List
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Proper Name PEG-INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103964 0 1 10162002 180 MCGML ( 180 MCGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
103964 0 2 10162002 180 MCG05 ML ( 360 MCGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
103964 5204 3 9292011 135 MCG05 ML ( 270 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
ApplicantLicense No HORIZON PHARMA IRELAND LTD 2022
Trade Name ACTIMMUNE
Proper Name INTERFERON GAMMA-1B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103836 0 1 2251999 100 MCG05 ML ( 200 MCGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No HORIZON PHARMA RHEUMATOLOGY LLC 1998
Trade Name KRYSTEXXA
Proper Name PEGLOTICASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125293 0 1 9142010 8MGML ( 8MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 24 of 42
CDER Billable Biologic Product List
ApplicantLicense No HUMAN GENOME SCIENCES INC 1820
Trade Name BENLYSTA
Proper Name BELIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125370 0 1 392011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
120 MG ( 120 MGVIAL )
125370 0 2 392011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
400 MG ( 400 MGVIAL )
125370 0 3 392011
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )
125370 0 4 392011
SOLUTION SUBCUTANEOUS AUTOINJECTOR
200 MGML ( 200 MGML )
BLASTN
761043 0
Product
1
Approval Date
7202017
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )
Trade Name
Proper Name
RAXIBACUMAB
RAXIBACUMAB
BLASTN
125349 0
Product
1
Approval Date
12142012
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1700 MG34 ML ( 50 MGML )
ApplicantLicense No IMCLONE LLC 1695
Trade Name ERBITUX
Proper Name CETUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125084 0 1 2122004 100 MG50 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 25 of 42
CDER Billable Biologic Product List
ApplicantLicense No IMCLONE LLC 1695
125084 0 2 2122004 200 MG100 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No IMMUNEX CORP 1132
Trade Name ENBREL
Proper Name ETANERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103795 0 1 1121998
POWDER SUBCUTANEOUS MULTI-DOSE VIAL
25 MG ( 25 MGVIAL )
103795 5184 2 9272004
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
50 MGML ( 50 MGML )
103795 0 3 9272004
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MGML ( 50 MGML )
103795 5184 4 9272004
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
25 MG05 ML ( 50 MGML )
103795 5556 5 9142017
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MGML ( 50 MGML )
ApplicantLicense No IPSEN BIOPHARM LIMITED 1787
Trade Name DYSPORT
Proper Name ABOBOTULINUMTOXINA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125274 0 1 4292009
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
300 UNITS ( 300 UNITSVIAL )
125274 0 2 4292009
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
500 UNITS ( 500 UNITSVIAL )
March 2018 Page 26 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
Trade Name DARZALEX
Proper Name DARATUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761036 0 1 11162015
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG5 ML ( 20 MGML )
761036 0 2 11162015
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
400 MG20 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
103772 0
REMICADE
INFLIXIMAB
Approval Date Product
8241998 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
BLASTN
103575 0
REOPRO
ABCIXIMAB
Approval Date Product
12221994 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
10 MG5 ML ( 2 MGML )
Trade Name
Proper Name
BLASTN
125289 0
SIMPONI
GOLIMUMAB
Approval Date Product
4242009 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
50 MG05 ML ( 100 MGML )
125289 0 2 4242009
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MG05 ML ( 100 MGML )
125289 0 3 4242009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
100 MGML ( 100 MGML )
March 2018 Page 27 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
125289 0 4 4242009 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name SIMPONI ARIA
Proper Name GOLIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125433 0 1 7182013 50 MG4 ML ( 125 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name STELARA
Proper Name USTEKINUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125261 0 1 9252009 90 MGML ( 90 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125261 0 2 9252009 45 MG05 ML ( 90 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL amp PREFILLED SYRINGE
125261 0 3 9252009 130 MG26 ML ( 5 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761044 0 1 9232016 130 MG26 ML ( 5 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SYLVANT
Proper Name SILTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125496 0 1 4232014 100 MG ( 100 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125496 0 2 4232014 400 MG ( 400 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 28 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
Trade Name TREMFYA
Proper Name GUSELKUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761061 0 1 7132017 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No JAZZ PHARMACEUTICALS INC 1901
Trade Name ERWINAZE
Proper Name ASPARAGINASE ERWINIA CHRYSANTHEMI
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
105359 0 1 11182011 10000 IU ( 10000 IUVIAL )
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103770 0 1 6191998
SOLUTION INTRAMUSCULAR
50 MG05 ML ( 100 MGML )
SINGLE-DOSE VIAL
103770 0 2 6191998
SOLUTION INTRAMUSCULAR
100 MGML ( 100 MGML )
SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name ILUMYA
Proper Name TILDRAKIZUMAB-ASMN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761067 0 1 3202018 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name INTRON A
March 2018 Page 29 of 42
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103132 0 1 641986 10 MIU ( 10 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL INTRAVENOUS SINGLE-DOSE VIAL
103132 0 2 641986 18 MIU ( 18 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL
103132 0 3 641986 50 MIU ( 50 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL
103132 0 4 641986 228 MIU38 ML ( 6 MIUML )
SOLUTION INTRAMUSCULAR SUBCUTANEOUS MULTI-DOSE VIAL
103132 0 5 641986 32 MIU32 ML ( 10 MIUML )
SOLUTION INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL MULTI-DOSE VIAL
Trade Name KEYTRUDA
Proper Name PEMBROLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125514 0 1 942014 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125514 1 2 1152015 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 0 1 1192001 74 MCG ( 74 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SYLATRON
Proper Name PEGINTERFERON ALFA-2B
March 2018 Page 30 of 42
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 5153 2 3292011 296 MCG ( 296 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 3 3292011 444 MCG ( 444 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 4 3292011 888 MCG ( 888 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name ZINPLAVA
Proper Name BEZLOTOXUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761046 0 1 10212016 1000 MG40 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No MERZ PHARMACEUTICALS GMBH 1830
Trade Name XEOMIN
Proper Name INCOBOTULINUMTOXINA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125360 0 1 7302010
POWDER INTRAMUSCULAR
50 U ( 50 UVIAL )
SINGLE-DOSE VIAL
125360 0 2 7302010
POWDER INTRAMUSCULAR
100 U ( 100 UVIAL )
SINGLE-DOSE VIAL
125360 3 3 11202015
POWDER INTRAMUSCULAR
200 U ( 200 UVIAL )
SINGLE-DOSE VIAL
March 2018 Page 31 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
Trade Name ARZERRA
Proper Name OFATUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125326 0 1 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG5 ML ( 20 MGML )
125326 0 2 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1000 MG50 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
125504 0
COSENTYX
SECUKINUMAB
Approval Date Product
1212015 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
150 MG ( 150 MGVIAL )
125504 0 2 1212015
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MGML ( 150 MGML )
125504 0 3 1212015
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MGML ( 150 MGML )
Trade Name
Proper Name
BLASTN
125290 0
EXTAVIA
INTERFERON BETA-1B
Approval Date Product
8142009 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
03 MG ( 03 MGVIAL )
Trade Name
Proper Name
BLASTN
125319 0
ILARIS
CANAKINUMAB
Approval Date Product
6172009 1
PotencyDosage FormRoutePresentation
180 MGVIAL ( 180 MGVIAL )
March 2018 Page 32 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
125319 88 2 12222016 150 MG ( 150 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
125319 0 3 12222016 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SIMULECT
Proper Name BASILIXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103764 0 1 5121998 10 MG ( 10 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
103764 0 2 5121998 20 MG ( 20 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No NPS PHARMACEUTICALS INC 1908
Trade Name NATPARA
Proper Name PARATHYROID HORMONE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 33 of 42
CDER Billable Biologic Product List
ApplicantLicense No PROMETHEUS LABORATORIES INC 1848
Trade Name PROLEUKIN
Proper Name ALDESLEUKIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103293 0 1 551992 22 MIU ( 22 MIUVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760
Trade Name ARCALYST
Proper Name RILONACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125249 0 1 2272008
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
220MG ( 220MGVIAL )
Trade Name
Proper Name
DUPIXENT
DUPILUMAB
BLASTN
761055 0
Product
1
Approval Date
3282017
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
300 MG2 ML ( 150 MGML )
Trade Name
Proper Name
EYLEA
AFLIBERCEPT
BLASTN
125387 0
Product
1
Approval Date
11182011
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
2 MG005 ML ( 40 MGML )
March 2018 Page 34 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Trade Name ELITEK
Proper Name RASBURICASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103946 0 1 7122002
POWDER INTRAVENOUS SINGLE-DOSE VIAL
15 MG ( 15 MGVIAL )
103946 5020 2 162006
POWDER INTRAVENOUS SINGLE-DOSE VIAL
75 MG ( 75 MGVIAL )
Trade Name
Proper Name
BLASTN
761037 0
KEVZARA
SARILUMAB
Approval Date Product
5222017 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MG114 ML ( 13158 MGML )
761037 0 2 5222017
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MG114 ML ( 17544 MGML )
761037 1 3 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MG114 ML ( 13158 MGML )
761037 1 4 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
200 MG114 ML ( 17544 MGML )
Trade Name
Proper Name
BLASTN
103362 0
LEUKINE
SARGRAMOSTIM
Approval Date Product
351991 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
250 MCG ( 250 MCGVIAL )
103362 0 2 351991
SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL
500 MCGML ( 500 MCGML )
Trade Name PRALUENT
March 2018 Page 35 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Proper Name ALIROCUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125559 0 1 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 2 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 3 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125559 0 4 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name ZALTRAP
Proper Name ZIV-AFLIBERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125418 0 1 832012 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125418 0 2 832012 200 MG8 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SEATTLE GENETICS INC 1853
Trade Name ADCETRIS
Proper Name BRENTUXIMAB VEDOTIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125388 1 1 8192011 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 36 of 42
CDER Billable Biologic Product List
ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593
Trade Name ELAPRASE
Proper Name IDURSULFASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125151 0 1 7242006 6 MG3 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SICOR BIOTECH UAB 1803
Trade Name GRANIX
Proper Name TBO-FILGRASTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125294 0 1 8292012
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
300 MCG0 5 ML ( 600 MCGML )
125294 0 2 8292012
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
480 MCG08 ML ( 600 MCGML )
ApplicantLicense No SMITH AND NEPHEW INC 2004
Trade Name REGRANEX
Proper Name BECAPLERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103691 0 1 12161997
GEL TOPICAL
100 UG ( 100 UGGM )
Trade Name
Proper Name
SANTYL
COLLAGENASE
BLASTN
101995 0
Product
1
Approval Date
641965
PotencyDosage FormRoutePresentation
OINTMENT TOPICAL
30 G amp 90 G TUBE ( 250 UGRAM )
March 2018 Page 37 of 42
CDER Billable Biologic Product List
ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718
Trade Name MYOBLOC
Proper Name RIMABOTULINUM TOXIN B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103846 0 1 1282002
SOLUTION INTRAMUSCULAR
2500 IU05 ML ( 5000 IUML )
SINGLE-DOSE VIAL
103846 0 3 1282002
SOLUTION INTRAMUSCULAR
10000 IU2 ML ( 5000 IUML )
SINGLE-DOSE VIAL
Proper Name RIMABOTULINUMTOXINB
BLASTN
103846 0
Product
2
Approval Date
1282002
PotencyDosage FormRoutePresentation
SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL
5000 IUML ( 5000 IUML )
ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832
Trade Name ZEVALIN
Proper Name IBRITUMOMAB TIUXETAN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125019 0 1 2192002 32 MG2 ML ( 16 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
Trade Name KEPIVANCE
Proper Name PALIFERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125103 0 1 12152004 625 MG ( 625 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name KINERET
Proper Name ANAKINRA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 38 of 42
CDER Billable Biologic Product List
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898
Trade Name ENTYVIO
Proper Name VEDOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125476 0 1 5202014 300 MG ( 300 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No TEVA RESPIRATORY LLC 2047
Trade Name CINQAIR
Proper Name RESLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761033 0 1 3232016 100 MG10 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No THERATECHNOLOGIES INC 2091
Trade Name TROGARZO
Proper Name IBALIZUMAB-UIYK
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761065 0 1 362018 200 MG133 ML ( 150 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 39 of 42
CDER Billable Biologic Product List
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
0375 MG03 ML ( 125 MGML )2222017 125422 038 1
ApplicantLicense No UCB INC 1736
Trade Name CIMZIA
Proper Name CERTOLIZUMAB PEGOL
BLASTN Approval Date PotencyDosage FormRoutePresentation Product
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
200 MG ( 200 MGVIAL ) 4222008 125160 0 1
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )5132009 125160 080 2
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
Trade Name CRYSVITA
Proper Name BUROSUMAB-TWZA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761068 0 1 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
10 MGML ( 10 MGML )
761068 0 2 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
20 MGML ( 20 MGML )
761068 0
Trade Name
Proper Name
BLASTN
March 2018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML ) 4172018 3
MEPSEVII
VESTRONIDASE ALFA-VJBK
Approval Date PotencyDosage FormRoutePresentation Product
Page 40 of 42
CDER Billable Biologic Product List
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
761047 0 1 11152017 10 MG5 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No UNITED THERAPEUTICS CORP 1993
Trade Name UNITUXIN
Proper Name DINUTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125516 0 1 3102015 175 MG5 ML ( 35 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053
Trade Name SILIQ
Proper Name BRODALUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761032 0 1 2152017 210 MG15 ML ( 140 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 41 of 42
CDER Billable Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No WYETH PHARMACEUTICALS INC 0003
Trade Name BESPONSA
Proper Name INOTUZUMAB OZOGAMICIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761040 0 1 8172017 09 MG ( 09 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 42 of 42
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 1 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
9172001 103951 0 26
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
200 MCGML ( 200 MCGML ) 09272012
103951 0 27 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
200 MCG04 ML ( 500 MCGML ) 09272012
103951 0 28 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
300 MCGML ( 300 MCGML ) 09272012
103951 0 29 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
300 MCG06 ML ( 500 MCGML ) 09272012
103951 0 30 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
500 MCGML ( 500 MCGML ) 09272012
ApplicantLicense No ASTELLAS PHARMACEUTICALS US INC 1748
Trade Name AMEVIVE
Proper Name ALEFACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125036 0 1 1302003 75 MGVIAL ( 75 MGVIAL ) 09242008
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
125036 0 2 1302003 15 MGVIAL ( 15 MGVIAL ) 09282012
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No BOEHRINGER INGELHEIM PHARMA KG 1251
Trade Name VERLUMA
Proper Name NOFETUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103769 0 1 10131998 10 MGML ( 10 MGML ) 08132013
INTRAVENOUS
March 2018 Page 2 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No CENTOCOR ORTHO BIOTECH PRODUCTS LP 1824
Trade Name ORTHOCLONE OKT3
Proper Name MUROMONAB-CD3
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103463 0 1 9141992 1 MGML ( 1 MGML ) 01112012
SOLUTION INTRAVENOUS AMPULE
ApplicantLicense No EISAI INCORPORATED 1862
Trade Name ONTAK
Proper Name DENILEUKIN DIFTITOX
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103767 0 1 251999 300 MCG2 ML ( 150 MCGML ) 01302014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No ELI LILLY AND CO 1611
Trade Name XIGRIS
Proper Name DROTRECOGIN ALFA (ACTIVATED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125029 0 1 11212001 5 MGVIAL ( 5 MGVIAL ) 10262011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125029 0 2 11212001 20 MGVIAL ( 20 MGVIAL ) 10102011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GENENTECH INC 1048
Trade Name RAPTIVA
Proper Name EFALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125075 0 1 10272003 125 MGVIAL ( 125 MGVIAL ) 09012009
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
March 2018 Page 3 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103976 0 2 6202003 125 MGVIAL ( 125 MGVIAL ) 08252016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103948 0 3 572001 10 MGVIAL ( 10 MGVIAL ) 07062011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name MYOZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125141 0 1 4282006 50 MGVIAL ( 50 MGVIAL ) 10172014
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name BEXXAR THERAPEUTIC REGIME
Proper Name TOSITUMOMAB AND IODINE I-131 TOSITUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125011 0 1 6272003 01 MGML I-131 TOSITUMOMAB ( 01 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 2 6272003 11 MGML I-131 TOSITUMOMAB ( 11 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 3 6272003 14 MGML TOSITUMOMAB ( 14 MGML 03102014 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 4 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No HEMISPHERX BIOPHARMA INC 1703
Trade Name ALFERON N INJECTION
Proper Name INTERFERON ALFA-N3 (HUMAN LEUKOCYTE DERIVED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103158 0 1 10101989 5 MIUVIAL ( 5 MIUVIAL ) 06272013
SOLUTION INTRALESIONAL MULTI-DOSE VIAL
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name ROFERON A
Proper Name INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103145 0 1 641986 3 MIU05 ML ( 3 MIU05 ML ) 06012009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name ZENAPAX
Proper Name DACLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103749 0 1 12101997 25 MG5 ML ( 25 MG5 ML ) 07072011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No KADMON PHARMACEUTICALS LLC 1867
Trade Name INFERGEN
Proper Name INTERFERON ALFACON-1
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103663 0 1 1061997 9 MCG03 ML ( 30 MCGML ) 07252013
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 5 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103770 0 3 6191998 50 MGVIAL ( 50 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
103770 0 4 6191998 100 MGVIAL ( 100 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name INTRON A
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103132 0 6 641986 10 MIUML ( 10 MIUML ) 09232013
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103132 0 7 641986 225 MIU15 ML ( 225 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 8 641986 375 MIU15 ML ( 375 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 9 641986 75 MIU15 ML ( 75 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103949 0 5 1192001 675 MCGPEN ( 675 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 6 1192001 108 MCGPEN ( 108 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
March 2018 Page 6 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name PEGINTRON
103949 0 7 1192001 1184 MCGVIAL ( 1184 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 8 1192001 162 MCGPEN ( 162 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 9 1192001 1776 MCGVIAL ( 1776 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 10 1192001 2025 MCGPEN ( 2025 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 11 1192001 222 MCGVIAL ( 222 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No PALATIN TECHNOLOGIES INC 1588
Trade Name NEUTROSPEC TECHNETIUM (99M TC)
Proper Name FANOLESOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103928 0 1 722004 025 MGVIAL ( 025 MGVIAL ) 09222008
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No RECORDATI RARE DISEASES INC 1899
Trade Name ELSPAR
Proper Name ASPARAGINASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
101063 0 1 1101978 10000 IU ( 10000 IUVIAL ) 04092014
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
March 2018 Page 7 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No SCHERING CORP 0994
Trade Name PEGINTRONREBETOL COMBO PACK
Proper Name PEGINTERFERON ALFA-2B AND RIBAVIRIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125196 0 1 6132008 ( 4 (120 MCG05ML) REDIPEN amp 140 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 2 6132008 ( 4 (150 MCG05ML) REDIPEN amp 168 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 3 6132008 ( 4 (150 MCG05ML) REDIPEN amp 196 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 4 6132008 ( 4 (50 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 5 6132008 ( 4 (80 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125422 0 2 10172012 05 MG ( 25 MGML ) 08082017
SOLUTION INTRAVETREAL SINGLE-DOSE VIAL
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125164 0 10 11142007 50 MCGML ( 50 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 8 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
125164 0 11 11142007 100 MCGML ( 100 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 12 11142007 200 MCGML ( 200 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 13 11142007 300 MCGML ( 300 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 14 11142007 400 MCGML ( 400 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 15 11142007 400 MCG06 ML ( 400 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 16 11142007 600 MCGML ( 600 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 17 11142007 600 MCG06 ML ( 600 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 18 11142007 800 MCG06 ML ( 800 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 19 11142007 1000 MCGML ( 1000 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 9 of 9
CDER Billable Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Proper Name TENECTEPLASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103909 0 1 622000 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103976 0 1 6202003 150 MG ( 150 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103948 0 1 572001
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML )
Trade Name
Proper Name
FABRAZYME
AGALSIDASE BETA
BLASTN
103979 0
Product
1
Approval Date
4242003
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
5 MG ( 5 MGVIAL )
103979 0 2 4242003
POWDER INTRAVENOUS SINGLE-DOSE VIAL
35 MG ( 35 MGVIAL )
Trade Name
Proper Name
LEMTRADA
ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 22 of 42
CDER Billable Biologic Product List
ApplicantLicense No GENZYME CORP 1596
103948 5139 2 11142014 12 MG12 ML ( 10MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name LUMIZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125291 0 1 5242010 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name NUCALA
Proper Name MEPOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125526 0 1 11142015
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
TANZEUM
ALBIGLUTIDE
BLASTN
125431 0
Product
1
Approval Date
4152014
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS AUTOINJECTOR
30 MG ( 30 MGAUTOINJECTOR )
125431 0 2 4152014
POWDER SUBCUTANEOUS AUTOINJECTOR
50 MG ( 50 MGAUTOINJECTOR )
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name PEGASYS
Proper Name PEGINTERFERON ALFA 2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103964 5204 4 9292011 180 MCG05 ML ( 360 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 23 of 42
CDER Billable Biologic Product List
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Proper Name PEG-INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103964 0 1 10162002 180 MCGML ( 180 MCGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
103964 0 2 10162002 180 MCG05 ML ( 360 MCGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
103964 5204 3 9292011 135 MCG05 ML ( 270 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
ApplicantLicense No HORIZON PHARMA IRELAND LTD 2022
Trade Name ACTIMMUNE
Proper Name INTERFERON GAMMA-1B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103836 0 1 2251999 100 MCG05 ML ( 200 MCGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No HORIZON PHARMA RHEUMATOLOGY LLC 1998
Trade Name KRYSTEXXA
Proper Name PEGLOTICASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125293 0 1 9142010 8MGML ( 8MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 24 of 42
CDER Billable Biologic Product List
ApplicantLicense No HUMAN GENOME SCIENCES INC 1820
Trade Name BENLYSTA
Proper Name BELIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125370 0 1 392011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
120 MG ( 120 MGVIAL )
125370 0 2 392011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
400 MG ( 400 MGVIAL )
125370 0 3 392011
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )
125370 0 4 392011
SOLUTION SUBCUTANEOUS AUTOINJECTOR
200 MGML ( 200 MGML )
BLASTN
761043 0
Product
1
Approval Date
7202017
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )
Trade Name
Proper Name
RAXIBACUMAB
RAXIBACUMAB
BLASTN
125349 0
Product
1
Approval Date
12142012
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1700 MG34 ML ( 50 MGML )
ApplicantLicense No IMCLONE LLC 1695
Trade Name ERBITUX
Proper Name CETUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125084 0 1 2122004 100 MG50 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 25 of 42
CDER Billable Biologic Product List
ApplicantLicense No IMCLONE LLC 1695
125084 0 2 2122004 200 MG100 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No IMMUNEX CORP 1132
Trade Name ENBREL
Proper Name ETANERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103795 0 1 1121998
POWDER SUBCUTANEOUS MULTI-DOSE VIAL
25 MG ( 25 MGVIAL )
103795 5184 2 9272004
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
50 MGML ( 50 MGML )
103795 0 3 9272004
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MGML ( 50 MGML )
103795 5184 4 9272004
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
25 MG05 ML ( 50 MGML )
103795 5556 5 9142017
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MGML ( 50 MGML )
ApplicantLicense No IPSEN BIOPHARM LIMITED 1787
Trade Name DYSPORT
Proper Name ABOBOTULINUMTOXINA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125274 0 1 4292009
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
300 UNITS ( 300 UNITSVIAL )
125274 0 2 4292009
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
500 UNITS ( 500 UNITSVIAL )
March 2018 Page 26 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
Trade Name DARZALEX
Proper Name DARATUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761036 0 1 11162015
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG5 ML ( 20 MGML )
761036 0 2 11162015
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
400 MG20 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
103772 0
REMICADE
INFLIXIMAB
Approval Date Product
8241998 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
BLASTN
103575 0
REOPRO
ABCIXIMAB
Approval Date Product
12221994 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
10 MG5 ML ( 2 MGML )
Trade Name
Proper Name
BLASTN
125289 0
SIMPONI
GOLIMUMAB
Approval Date Product
4242009 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
50 MG05 ML ( 100 MGML )
125289 0 2 4242009
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MG05 ML ( 100 MGML )
125289 0 3 4242009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
100 MGML ( 100 MGML )
March 2018 Page 27 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
125289 0 4 4242009 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name SIMPONI ARIA
Proper Name GOLIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125433 0 1 7182013 50 MG4 ML ( 125 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name STELARA
Proper Name USTEKINUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125261 0 1 9252009 90 MGML ( 90 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125261 0 2 9252009 45 MG05 ML ( 90 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL amp PREFILLED SYRINGE
125261 0 3 9252009 130 MG26 ML ( 5 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761044 0 1 9232016 130 MG26 ML ( 5 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SYLVANT
Proper Name SILTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125496 0 1 4232014 100 MG ( 100 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125496 0 2 4232014 400 MG ( 400 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 28 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
Trade Name TREMFYA
Proper Name GUSELKUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761061 0 1 7132017 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No JAZZ PHARMACEUTICALS INC 1901
Trade Name ERWINAZE
Proper Name ASPARAGINASE ERWINIA CHRYSANTHEMI
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
105359 0 1 11182011 10000 IU ( 10000 IUVIAL )
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103770 0 1 6191998
SOLUTION INTRAMUSCULAR
50 MG05 ML ( 100 MGML )
SINGLE-DOSE VIAL
103770 0 2 6191998
SOLUTION INTRAMUSCULAR
100 MGML ( 100 MGML )
SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name ILUMYA
Proper Name TILDRAKIZUMAB-ASMN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761067 0 1 3202018 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name INTRON A
March 2018 Page 29 of 42
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103132 0 1 641986 10 MIU ( 10 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL INTRAVENOUS SINGLE-DOSE VIAL
103132 0 2 641986 18 MIU ( 18 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL
103132 0 3 641986 50 MIU ( 50 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL
103132 0 4 641986 228 MIU38 ML ( 6 MIUML )
SOLUTION INTRAMUSCULAR SUBCUTANEOUS MULTI-DOSE VIAL
103132 0 5 641986 32 MIU32 ML ( 10 MIUML )
SOLUTION INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL MULTI-DOSE VIAL
Trade Name KEYTRUDA
Proper Name PEMBROLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125514 0 1 942014 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125514 1 2 1152015 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 0 1 1192001 74 MCG ( 74 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SYLATRON
Proper Name PEGINTERFERON ALFA-2B
March 2018 Page 30 of 42
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 5153 2 3292011 296 MCG ( 296 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 3 3292011 444 MCG ( 444 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 4 3292011 888 MCG ( 888 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name ZINPLAVA
Proper Name BEZLOTOXUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761046 0 1 10212016 1000 MG40 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No MERZ PHARMACEUTICALS GMBH 1830
Trade Name XEOMIN
Proper Name INCOBOTULINUMTOXINA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125360 0 1 7302010
POWDER INTRAMUSCULAR
50 U ( 50 UVIAL )
SINGLE-DOSE VIAL
125360 0 2 7302010
POWDER INTRAMUSCULAR
100 U ( 100 UVIAL )
SINGLE-DOSE VIAL
125360 3 3 11202015
POWDER INTRAMUSCULAR
200 U ( 200 UVIAL )
SINGLE-DOSE VIAL
March 2018 Page 31 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
Trade Name ARZERRA
Proper Name OFATUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125326 0 1 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG5 ML ( 20 MGML )
125326 0 2 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1000 MG50 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
125504 0
COSENTYX
SECUKINUMAB
Approval Date Product
1212015 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
150 MG ( 150 MGVIAL )
125504 0 2 1212015
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MGML ( 150 MGML )
125504 0 3 1212015
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MGML ( 150 MGML )
Trade Name
Proper Name
BLASTN
125290 0
EXTAVIA
INTERFERON BETA-1B
Approval Date Product
8142009 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
03 MG ( 03 MGVIAL )
Trade Name
Proper Name
BLASTN
125319 0
ILARIS
CANAKINUMAB
Approval Date Product
6172009 1
PotencyDosage FormRoutePresentation
180 MGVIAL ( 180 MGVIAL )
March 2018 Page 32 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
125319 88 2 12222016 150 MG ( 150 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
125319 0 3 12222016 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SIMULECT
Proper Name BASILIXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103764 0 1 5121998 10 MG ( 10 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
103764 0 2 5121998 20 MG ( 20 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No NPS PHARMACEUTICALS INC 1908
Trade Name NATPARA
Proper Name PARATHYROID HORMONE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 33 of 42
CDER Billable Biologic Product List
ApplicantLicense No PROMETHEUS LABORATORIES INC 1848
Trade Name PROLEUKIN
Proper Name ALDESLEUKIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103293 0 1 551992 22 MIU ( 22 MIUVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760
Trade Name ARCALYST
Proper Name RILONACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125249 0 1 2272008
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
220MG ( 220MGVIAL )
Trade Name
Proper Name
DUPIXENT
DUPILUMAB
BLASTN
761055 0
Product
1
Approval Date
3282017
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
300 MG2 ML ( 150 MGML )
Trade Name
Proper Name
EYLEA
AFLIBERCEPT
BLASTN
125387 0
Product
1
Approval Date
11182011
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
2 MG005 ML ( 40 MGML )
March 2018 Page 34 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Trade Name ELITEK
Proper Name RASBURICASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103946 0 1 7122002
POWDER INTRAVENOUS SINGLE-DOSE VIAL
15 MG ( 15 MGVIAL )
103946 5020 2 162006
POWDER INTRAVENOUS SINGLE-DOSE VIAL
75 MG ( 75 MGVIAL )
Trade Name
Proper Name
BLASTN
761037 0
KEVZARA
SARILUMAB
Approval Date Product
5222017 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MG114 ML ( 13158 MGML )
761037 0 2 5222017
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MG114 ML ( 17544 MGML )
761037 1 3 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MG114 ML ( 13158 MGML )
761037 1 4 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
200 MG114 ML ( 17544 MGML )
Trade Name
Proper Name
BLASTN
103362 0
LEUKINE
SARGRAMOSTIM
Approval Date Product
351991 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
250 MCG ( 250 MCGVIAL )
103362 0 2 351991
SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL
500 MCGML ( 500 MCGML )
Trade Name PRALUENT
March 2018 Page 35 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Proper Name ALIROCUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125559 0 1 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 2 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 3 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125559 0 4 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name ZALTRAP
Proper Name ZIV-AFLIBERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125418 0 1 832012 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125418 0 2 832012 200 MG8 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SEATTLE GENETICS INC 1853
Trade Name ADCETRIS
Proper Name BRENTUXIMAB VEDOTIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125388 1 1 8192011 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 36 of 42
CDER Billable Biologic Product List
ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593
Trade Name ELAPRASE
Proper Name IDURSULFASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125151 0 1 7242006 6 MG3 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SICOR BIOTECH UAB 1803
Trade Name GRANIX
Proper Name TBO-FILGRASTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125294 0 1 8292012
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
300 MCG0 5 ML ( 600 MCGML )
125294 0 2 8292012
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
480 MCG08 ML ( 600 MCGML )
ApplicantLicense No SMITH AND NEPHEW INC 2004
Trade Name REGRANEX
Proper Name BECAPLERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103691 0 1 12161997
GEL TOPICAL
100 UG ( 100 UGGM )
Trade Name
Proper Name
SANTYL
COLLAGENASE
BLASTN
101995 0
Product
1
Approval Date
641965
PotencyDosage FormRoutePresentation
OINTMENT TOPICAL
30 G amp 90 G TUBE ( 250 UGRAM )
March 2018 Page 37 of 42
CDER Billable Biologic Product List
ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718
Trade Name MYOBLOC
Proper Name RIMABOTULINUM TOXIN B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103846 0 1 1282002
SOLUTION INTRAMUSCULAR
2500 IU05 ML ( 5000 IUML )
SINGLE-DOSE VIAL
103846 0 3 1282002
SOLUTION INTRAMUSCULAR
10000 IU2 ML ( 5000 IUML )
SINGLE-DOSE VIAL
Proper Name RIMABOTULINUMTOXINB
BLASTN
103846 0
Product
2
Approval Date
1282002
PotencyDosage FormRoutePresentation
SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL
5000 IUML ( 5000 IUML )
ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832
Trade Name ZEVALIN
Proper Name IBRITUMOMAB TIUXETAN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125019 0 1 2192002 32 MG2 ML ( 16 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
Trade Name KEPIVANCE
Proper Name PALIFERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125103 0 1 12152004 625 MG ( 625 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name KINERET
Proper Name ANAKINRA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 38 of 42
CDER Billable Biologic Product List
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898
Trade Name ENTYVIO
Proper Name VEDOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125476 0 1 5202014 300 MG ( 300 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No TEVA RESPIRATORY LLC 2047
Trade Name CINQAIR
Proper Name RESLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761033 0 1 3232016 100 MG10 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No THERATECHNOLOGIES INC 2091
Trade Name TROGARZO
Proper Name IBALIZUMAB-UIYK
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761065 0 1 362018 200 MG133 ML ( 150 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 39 of 42
CDER Billable Biologic Product List
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
0375 MG03 ML ( 125 MGML )2222017 125422 038 1
ApplicantLicense No UCB INC 1736
Trade Name CIMZIA
Proper Name CERTOLIZUMAB PEGOL
BLASTN Approval Date PotencyDosage FormRoutePresentation Product
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
200 MG ( 200 MGVIAL ) 4222008 125160 0 1
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )5132009 125160 080 2
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
Trade Name CRYSVITA
Proper Name BUROSUMAB-TWZA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761068 0 1 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
10 MGML ( 10 MGML )
761068 0 2 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
20 MGML ( 20 MGML )
761068 0
Trade Name
Proper Name
BLASTN
March 2018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML ) 4172018 3
MEPSEVII
VESTRONIDASE ALFA-VJBK
Approval Date PotencyDosage FormRoutePresentation Product
Page 40 of 42
CDER Billable Biologic Product List
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
761047 0 1 11152017 10 MG5 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No UNITED THERAPEUTICS CORP 1993
Trade Name UNITUXIN
Proper Name DINUTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125516 0 1 3102015 175 MG5 ML ( 35 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053
Trade Name SILIQ
Proper Name BRODALUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761032 0 1 2152017 210 MG15 ML ( 140 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 41 of 42
CDER Billable Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No WYETH PHARMACEUTICALS INC 0003
Trade Name BESPONSA
Proper Name INOTUZUMAB OZOGAMICIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761040 0 1 8172017 09 MG ( 09 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 42 of 42
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 1 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
9172001 103951 0 26
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
200 MCGML ( 200 MCGML ) 09272012
103951 0 27 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
200 MCG04 ML ( 500 MCGML ) 09272012
103951 0 28 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
300 MCGML ( 300 MCGML ) 09272012
103951 0 29 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
300 MCG06 ML ( 500 MCGML ) 09272012
103951 0 30 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
500 MCGML ( 500 MCGML ) 09272012
ApplicantLicense No ASTELLAS PHARMACEUTICALS US INC 1748
Trade Name AMEVIVE
Proper Name ALEFACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125036 0 1 1302003 75 MGVIAL ( 75 MGVIAL ) 09242008
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
125036 0 2 1302003 15 MGVIAL ( 15 MGVIAL ) 09282012
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No BOEHRINGER INGELHEIM PHARMA KG 1251
Trade Name VERLUMA
Proper Name NOFETUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103769 0 1 10131998 10 MGML ( 10 MGML ) 08132013
INTRAVENOUS
March 2018 Page 2 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No CENTOCOR ORTHO BIOTECH PRODUCTS LP 1824
Trade Name ORTHOCLONE OKT3
Proper Name MUROMONAB-CD3
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103463 0 1 9141992 1 MGML ( 1 MGML ) 01112012
SOLUTION INTRAVENOUS AMPULE
ApplicantLicense No EISAI INCORPORATED 1862
Trade Name ONTAK
Proper Name DENILEUKIN DIFTITOX
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103767 0 1 251999 300 MCG2 ML ( 150 MCGML ) 01302014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No ELI LILLY AND CO 1611
Trade Name XIGRIS
Proper Name DROTRECOGIN ALFA (ACTIVATED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125029 0 1 11212001 5 MGVIAL ( 5 MGVIAL ) 10262011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125029 0 2 11212001 20 MGVIAL ( 20 MGVIAL ) 10102011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GENENTECH INC 1048
Trade Name RAPTIVA
Proper Name EFALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125075 0 1 10272003 125 MGVIAL ( 125 MGVIAL ) 09012009
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
March 2018 Page 3 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103976 0 2 6202003 125 MGVIAL ( 125 MGVIAL ) 08252016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103948 0 3 572001 10 MGVIAL ( 10 MGVIAL ) 07062011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name MYOZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125141 0 1 4282006 50 MGVIAL ( 50 MGVIAL ) 10172014
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name BEXXAR THERAPEUTIC REGIME
Proper Name TOSITUMOMAB AND IODINE I-131 TOSITUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125011 0 1 6272003 01 MGML I-131 TOSITUMOMAB ( 01 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 2 6272003 11 MGML I-131 TOSITUMOMAB ( 11 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 3 6272003 14 MGML TOSITUMOMAB ( 14 MGML 03102014 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 4 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No HEMISPHERX BIOPHARMA INC 1703
Trade Name ALFERON N INJECTION
Proper Name INTERFERON ALFA-N3 (HUMAN LEUKOCYTE DERIVED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103158 0 1 10101989 5 MIUVIAL ( 5 MIUVIAL ) 06272013
SOLUTION INTRALESIONAL MULTI-DOSE VIAL
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name ROFERON A
Proper Name INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103145 0 1 641986 3 MIU05 ML ( 3 MIU05 ML ) 06012009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name ZENAPAX
Proper Name DACLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103749 0 1 12101997 25 MG5 ML ( 25 MG5 ML ) 07072011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No KADMON PHARMACEUTICALS LLC 1867
Trade Name INFERGEN
Proper Name INTERFERON ALFACON-1
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103663 0 1 1061997 9 MCG03 ML ( 30 MCGML ) 07252013
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 5 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103770 0 3 6191998 50 MGVIAL ( 50 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
103770 0 4 6191998 100 MGVIAL ( 100 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name INTRON A
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103132 0 6 641986 10 MIUML ( 10 MIUML ) 09232013
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103132 0 7 641986 225 MIU15 ML ( 225 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 8 641986 375 MIU15 ML ( 375 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 9 641986 75 MIU15 ML ( 75 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103949 0 5 1192001 675 MCGPEN ( 675 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 6 1192001 108 MCGPEN ( 108 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
March 2018 Page 6 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name PEGINTRON
103949 0 7 1192001 1184 MCGVIAL ( 1184 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 8 1192001 162 MCGPEN ( 162 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 9 1192001 1776 MCGVIAL ( 1776 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 10 1192001 2025 MCGPEN ( 2025 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 11 1192001 222 MCGVIAL ( 222 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No PALATIN TECHNOLOGIES INC 1588
Trade Name NEUTROSPEC TECHNETIUM (99M TC)
Proper Name FANOLESOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103928 0 1 722004 025 MGVIAL ( 025 MGVIAL ) 09222008
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No RECORDATI RARE DISEASES INC 1899
Trade Name ELSPAR
Proper Name ASPARAGINASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
101063 0 1 1101978 10000 IU ( 10000 IUVIAL ) 04092014
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
March 2018 Page 7 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No SCHERING CORP 0994
Trade Name PEGINTRONREBETOL COMBO PACK
Proper Name PEGINTERFERON ALFA-2B AND RIBAVIRIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125196 0 1 6132008 ( 4 (120 MCG05ML) REDIPEN amp 140 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 2 6132008 ( 4 (150 MCG05ML) REDIPEN amp 168 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 3 6132008 ( 4 (150 MCG05ML) REDIPEN amp 196 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 4 6132008 ( 4 (50 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 5 6132008 ( 4 (80 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125422 0 2 10172012 05 MG ( 25 MGML ) 08082017
SOLUTION INTRAVETREAL SINGLE-DOSE VIAL
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125164 0 10 11142007 50 MCGML ( 50 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 8 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
125164 0 11 11142007 100 MCGML ( 100 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 12 11142007 200 MCGML ( 200 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 13 11142007 300 MCGML ( 300 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 14 11142007 400 MCGML ( 400 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 15 11142007 400 MCG06 ML ( 400 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 16 11142007 600 MCGML ( 600 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 17 11142007 600 MCG06 ML ( 600 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 18 11142007 800 MCG06 ML ( 800 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 19 11142007 1000 MCGML ( 1000 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 9 of 9
CDER Billable Biologic Product List
ApplicantLicense No GENZYME CORP 1596
103948 5139 2 11142014 12 MG12 ML ( 10MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name LUMIZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125291 0 1 5242010 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name NUCALA
Proper Name MEPOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125526 0 1 11142015
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
TANZEUM
ALBIGLUTIDE
BLASTN
125431 0
Product
1
Approval Date
4152014
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS AUTOINJECTOR
30 MG ( 30 MGAUTOINJECTOR )
125431 0 2 4152014
POWDER SUBCUTANEOUS AUTOINJECTOR
50 MG ( 50 MGAUTOINJECTOR )
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name PEGASYS
Proper Name PEGINTERFERON ALFA 2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103964 5204 4 9292011 180 MCG05 ML ( 360 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 23 of 42
CDER Billable Biologic Product List
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Proper Name PEG-INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103964 0 1 10162002 180 MCGML ( 180 MCGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
103964 0 2 10162002 180 MCG05 ML ( 360 MCGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
103964 5204 3 9292011 135 MCG05 ML ( 270 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
ApplicantLicense No HORIZON PHARMA IRELAND LTD 2022
Trade Name ACTIMMUNE
Proper Name INTERFERON GAMMA-1B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103836 0 1 2251999 100 MCG05 ML ( 200 MCGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No HORIZON PHARMA RHEUMATOLOGY LLC 1998
Trade Name KRYSTEXXA
Proper Name PEGLOTICASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125293 0 1 9142010 8MGML ( 8MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 24 of 42
CDER Billable Biologic Product List
ApplicantLicense No HUMAN GENOME SCIENCES INC 1820
Trade Name BENLYSTA
Proper Name BELIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125370 0 1 392011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
120 MG ( 120 MGVIAL )
125370 0 2 392011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
400 MG ( 400 MGVIAL )
125370 0 3 392011
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )
125370 0 4 392011
SOLUTION SUBCUTANEOUS AUTOINJECTOR
200 MGML ( 200 MGML )
BLASTN
761043 0
Product
1
Approval Date
7202017
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )
Trade Name
Proper Name
RAXIBACUMAB
RAXIBACUMAB
BLASTN
125349 0
Product
1
Approval Date
12142012
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1700 MG34 ML ( 50 MGML )
ApplicantLicense No IMCLONE LLC 1695
Trade Name ERBITUX
Proper Name CETUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125084 0 1 2122004 100 MG50 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 25 of 42
CDER Billable Biologic Product List
ApplicantLicense No IMCLONE LLC 1695
125084 0 2 2122004 200 MG100 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No IMMUNEX CORP 1132
Trade Name ENBREL
Proper Name ETANERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103795 0 1 1121998
POWDER SUBCUTANEOUS MULTI-DOSE VIAL
25 MG ( 25 MGVIAL )
103795 5184 2 9272004
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
50 MGML ( 50 MGML )
103795 0 3 9272004
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MGML ( 50 MGML )
103795 5184 4 9272004
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
25 MG05 ML ( 50 MGML )
103795 5556 5 9142017
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MGML ( 50 MGML )
ApplicantLicense No IPSEN BIOPHARM LIMITED 1787
Trade Name DYSPORT
Proper Name ABOBOTULINUMTOXINA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125274 0 1 4292009
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
300 UNITS ( 300 UNITSVIAL )
125274 0 2 4292009
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
500 UNITS ( 500 UNITSVIAL )
March 2018 Page 26 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
Trade Name DARZALEX
Proper Name DARATUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761036 0 1 11162015
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG5 ML ( 20 MGML )
761036 0 2 11162015
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
400 MG20 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
103772 0
REMICADE
INFLIXIMAB
Approval Date Product
8241998 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
BLASTN
103575 0
REOPRO
ABCIXIMAB
Approval Date Product
12221994 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
10 MG5 ML ( 2 MGML )
Trade Name
Proper Name
BLASTN
125289 0
SIMPONI
GOLIMUMAB
Approval Date Product
4242009 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
50 MG05 ML ( 100 MGML )
125289 0 2 4242009
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MG05 ML ( 100 MGML )
125289 0 3 4242009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
100 MGML ( 100 MGML )
March 2018 Page 27 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
125289 0 4 4242009 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name SIMPONI ARIA
Proper Name GOLIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125433 0 1 7182013 50 MG4 ML ( 125 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name STELARA
Proper Name USTEKINUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125261 0 1 9252009 90 MGML ( 90 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125261 0 2 9252009 45 MG05 ML ( 90 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL amp PREFILLED SYRINGE
125261 0 3 9252009 130 MG26 ML ( 5 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761044 0 1 9232016 130 MG26 ML ( 5 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SYLVANT
Proper Name SILTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125496 0 1 4232014 100 MG ( 100 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125496 0 2 4232014 400 MG ( 400 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 28 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
Trade Name TREMFYA
Proper Name GUSELKUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761061 0 1 7132017 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No JAZZ PHARMACEUTICALS INC 1901
Trade Name ERWINAZE
Proper Name ASPARAGINASE ERWINIA CHRYSANTHEMI
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
105359 0 1 11182011 10000 IU ( 10000 IUVIAL )
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103770 0 1 6191998
SOLUTION INTRAMUSCULAR
50 MG05 ML ( 100 MGML )
SINGLE-DOSE VIAL
103770 0 2 6191998
SOLUTION INTRAMUSCULAR
100 MGML ( 100 MGML )
SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name ILUMYA
Proper Name TILDRAKIZUMAB-ASMN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761067 0 1 3202018 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name INTRON A
March 2018 Page 29 of 42
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103132 0 1 641986 10 MIU ( 10 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL INTRAVENOUS SINGLE-DOSE VIAL
103132 0 2 641986 18 MIU ( 18 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL
103132 0 3 641986 50 MIU ( 50 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL
103132 0 4 641986 228 MIU38 ML ( 6 MIUML )
SOLUTION INTRAMUSCULAR SUBCUTANEOUS MULTI-DOSE VIAL
103132 0 5 641986 32 MIU32 ML ( 10 MIUML )
SOLUTION INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL MULTI-DOSE VIAL
Trade Name KEYTRUDA
Proper Name PEMBROLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125514 0 1 942014 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125514 1 2 1152015 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 0 1 1192001 74 MCG ( 74 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SYLATRON
Proper Name PEGINTERFERON ALFA-2B
March 2018 Page 30 of 42
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 5153 2 3292011 296 MCG ( 296 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 3 3292011 444 MCG ( 444 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 4 3292011 888 MCG ( 888 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name ZINPLAVA
Proper Name BEZLOTOXUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761046 0 1 10212016 1000 MG40 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No MERZ PHARMACEUTICALS GMBH 1830
Trade Name XEOMIN
Proper Name INCOBOTULINUMTOXINA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125360 0 1 7302010
POWDER INTRAMUSCULAR
50 U ( 50 UVIAL )
SINGLE-DOSE VIAL
125360 0 2 7302010
POWDER INTRAMUSCULAR
100 U ( 100 UVIAL )
SINGLE-DOSE VIAL
125360 3 3 11202015
POWDER INTRAMUSCULAR
200 U ( 200 UVIAL )
SINGLE-DOSE VIAL
March 2018 Page 31 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
Trade Name ARZERRA
Proper Name OFATUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125326 0 1 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG5 ML ( 20 MGML )
125326 0 2 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1000 MG50 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
125504 0
COSENTYX
SECUKINUMAB
Approval Date Product
1212015 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
150 MG ( 150 MGVIAL )
125504 0 2 1212015
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MGML ( 150 MGML )
125504 0 3 1212015
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MGML ( 150 MGML )
Trade Name
Proper Name
BLASTN
125290 0
EXTAVIA
INTERFERON BETA-1B
Approval Date Product
8142009 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
03 MG ( 03 MGVIAL )
Trade Name
Proper Name
BLASTN
125319 0
ILARIS
CANAKINUMAB
Approval Date Product
6172009 1
PotencyDosage FormRoutePresentation
180 MGVIAL ( 180 MGVIAL )
March 2018 Page 32 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
125319 88 2 12222016 150 MG ( 150 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
125319 0 3 12222016 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SIMULECT
Proper Name BASILIXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103764 0 1 5121998 10 MG ( 10 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
103764 0 2 5121998 20 MG ( 20 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No NPS PHARMACEUTICALS INC 1908
Trade Name NATPARA
Proper Name PARATHYROID HORMONE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 33 of 42
CDER Billable Biologic Product List
ApplicantLicense No PROMETHEUS LABORATORIES INC 1848
Trade Name PROLEUKIN
Proper Name ALDESLEUKIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103293 0 1 551992 22 MIU ( 22 MIUVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760
Trade Name ARCALYST
Proper Name RILONACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125249 0 1 2272008
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
220MG ( 220MGVIAL )
Trade Name
Proper Name
DUPIXENT
DUPILUMAB
BLASTN
761055 0
Product
1
Approval Date
3282017
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
300 MG2 ML ( 150 MGML )
Trade Name
Proper Name
EYLEA
AFLIBERCEPT
BLASTN
125387 0
Product
1
Approval Date
11182011
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
2 MG005 ML ( 40 MGML )
March 2018 Page 34 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Trade Name ELITEK
Proper Name RASBURICASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103946 0 1 7122002
POWDER INTRAVENOUS SINGLE-DOSE VIAL
15 MG ( 15 MGVIAL )
103946 5020 2 162006
POWDER INTRAVENOUS SINGLE-DOSE VIAL
75 MG ( 75 MGVIAL )
Trade Name
Proper Name
BLASTN
761037 0
KEVZARA
SARILUMAB
Approval Date Product
5222017 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MG114 ML ( 13158 MGML )
761037 0 2 5222017
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MG114 ML ( 17544 MGML )
761037 1 3 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MG114 ML ( 13158 MGML )
761037 1 4 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
200 MG114 ML ( 17544 MGML )
Trade Name
Proper Name
BLASTN
103362 0
LEUKINE
SARGRAMOSTIM
Approval Date Product
351991 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
250 MCG ( 250 MCGVIAL )
103362 0 2 351991
SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL
500 MCGML ( 500 MCGML )
Trade Name PRALUENT
March 2018 Page 35 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Proper Name ALIROCUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125559 0 1 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 2 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 3 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125559 0 4 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name ZALTRAP
Proper Name ZIV-AFLIBERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125418 0 1 832012 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125418 0 2 832012 200 MG8 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SEATTLE GENETICS INC 1853
Trade Name ADCETRIS
Proper Name BRENTUXIMAB VEDOTIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125388 1 1 8192011 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 36 of 42
CDER Billable Biologic Product List
ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593
Trade Name ELAPRASE
Proper Name IDURSULFASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125151 0 1 7242006 6 MG3 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SICOR BIOTECH UAB 1803
Trade Name GRANIX
Proper Name TBO-FILGRASTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125294 0 1 8292012
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
300 MCG0 5 ML ( 600 MCGML )
125294 0 2 8292012
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
480 MCG08 ML ( 600 MCGML )
ApplicantLicense No SMITH AND NEPHEW INC 2004
Trade Name REGRANEX
Proper Name BECAPLERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103691 0 1 12161997
GEL TOPICAL
100 UG ( 100 UGGM )
Trade Name
Proper Name
SANTYL
COLLAGENASE
BLASTN
101995 0
Product
1
Approval Date
641965
PotencyDosage FormRoutePresentation
OINTMENT TOPICAL
30 G amp 90 G TUBE ( 250 UGRAM )
March 2018 Page 37 of 42
CDER Billable Biologic Product List
ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718
Trade Name MYOBLOC
Proper Name RIMABOTULINUM TOXIN B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103846 0 1 1282002
SOLUTION INTRAMUSCULAR
2500 IU05 ML ( 5000 IUML )
SINGLE-DOSE VIAL
103846 0 3 1282002
SOLUTION INTRAMUSCULAR
10000 IU2 ML ( 5000 IUML )
SINGLE-DOSE VIAL
Proper Name RIMABOTULINUMTOXINB
BLASTN
103846 0
Product
2
Approval Date
1282002
PotencyDosage FormRoutePresentation
SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL
5000 IUML ( 5000 IUML )
ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832
Trade Name ZEVALIN
Proper Name IBRITUMOMAB TIUXETAN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125019 0 1 2192002 32 MG2 ML ( 16 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
Trade Name KEPIVANCE
Proper Name PALIFERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125103 0 1 12152004 625 MG ( 625 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name KINERET
Proper Name ANAKINRA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 38 of 42
CDER Billable Biologic Product List
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898
Trade Name ENTYVIO
Proper Name VEDOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125476 0 1 5202014 300 MG ( 300 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No TEVA RESPIRATORY LLC 2047
Trade Name CINQAIR
Proper Name RESLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761033 0 1 3232016 100 MG10 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No THERATECHNOLOGIES INC 2091
Trade Name TROGARZO
Proper Name IBALIZUMAB-UIYK
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761065 0 1 362018 200 MG133 ML ( 150 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 39 of 42
CDER Billable Biologic Product List
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
0375 MG03 ML ( 125 MGML )2222017 125422 038 1
ApplicantLicense No UCB INC 1736
Trade Name CIMZIA
Proper Name CERTOLIZUMAB PEGOL
BLASTN Approval Date PotencyDosage FormRoutePresentation Product
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
200 MG ( 200 MGVIAL ) 4222008 125160 0 1
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )5132009 125160 080 2
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
Trade Name CRYSVITA
Proper Name BUROSUMAB-TWZA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761068 0 1 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
10 MGML ( 10 MGML )
761068 0 2 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
20 MGML ( 20 MGML )
761068 0
Trade Name
Proper Name
BLASTN
March 2018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML ) 4172018 3
MEPSEVII
VESTRONIDASE ALFA-VJBK
Approval Date PotencyDosage FormRoutePresentation Product
Page 40 of 42
CDER Billable Biologic Product List
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
761047 0 1 11152017 10 MG5 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No UNITED THERAPEUTICS CORP 1993
Trade Name UNITUXIN
Proper Name DINUTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125516 0 1 3102015 175 MG5 ML ( 35 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053
Trade Name SILIQ
Proper Name BRODALUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761032 0 1 2152017 210 MG15 ML ( 140 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 41 of 42
CDER Billable Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No WYETH PHARMACEUTICALS INC 0003
Trade Name BESPONSA
Proper Name INOTUZUMAB OZOGAMICIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761040 0 1 8172017 09 MG ( 09 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 42 of 42
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 1 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
9172001 103951 0 26
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
200 MCGML ( 200 MCGML ) 09272012
103951 0 27 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
200 MCG04 ML ( 500 MCGML ) 09272012
103951 0 28 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
300 MCGML ( 300 MCGML ) 09272012
103951 0 29 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
300 MCG06 ML ( 500 MCGML ) 09272012
103951 0 30 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
500 MCGML ( 500 MCGML ) 09272012
ApplicantLicense No ASTELLAS PHARMACEUTICALS US INC 1748
Trade Name AMEVIVE
Proper Name ALEFACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125036 0 1 1302003 75 MGVIAL ( 75 MGVIAL ) 09242008
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
125036 0 2 1302003 15 MGVIAL ( 15 MGVIAL ) 09282012
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No BOEHRINGER INGELHEIM PHARMA KG 1251
Trade Name VERLUMA
Proper Name NOFETUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103769 0 1 10131998 10 MGML ( 10 MGML ) 08132013
INTRAVENOUS
March 2018 Page 2 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No CENTOCOR ORTHO BIOTECH PRODUCTS LP 1824
Trade Name ORTHOCLONE OKT3
Proper Name MUROMONAB-CD3
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103463 0 1 9141992 1 MGML ( 1 MGML ) 01112012
SOLUTION INTRAVENOUS AMPULE
ApplicantLicense No EISAI INCORPORATED 1862
Trade Name ONTAK
Proper Name DENILEUKIN DIFTITOX
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103767 0 1 251999 300 MCG2 ML ( 150 MCGML ) 01302014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No ELI LILLY AND CO 1611
Trade Name XIGRIS
Proper Name DROTRECOGIN ALFA (ACTIVATED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125029 0 1 11212001 5 MGVIAL ( 5 MGVIAL ) 10262011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125029 0 2 11212001 20 MGVIAL ( 20 MGVIAL ) 10102011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GENENTECH INC 1048
Trade Name RAPTIVA
Proper Name EFALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125075 0 1 10272003 125 MGVIAL ( 125 MGVIAL ) 09012009
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
March 2018 Page 3 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103976 0 2 6202003 125 MGVIAL ( 125 MGVIAL ) 08252016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103948 0 3 572001 10 MGVIAL ( 10 MGVIAL ) 07062011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name MYOZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125141 0 1 4282006 50 MGVIAL ( 50 MGVIAL ) 10172014
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name BEXXAR THERAPEUTIC REGIME
Proper Name TOSITUMOMAB AND IODINE I-131 TOSITUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125011 0 1 6272003 01 MGML I-131 TOSITUMOMAB ( 01 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 2 6272003 11 MGML I-131 TOSITUMOMAB ( 11 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 3 6272003 14 MGML TOSITUMOMAB ( 14 MGML 03102014 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 4 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No HEMISPHERX BIOPHARMA INC 1703
Trade Name ALFERON N INJECTION
Proper Name INTERFERON ALFA-N3 (HUMAN LEUKOCYTE DERIVED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103158 0 1 10101989 5 MIUVIAL ( 5 MIUVIAL ) 06272013
SOLUTION INTRALESIONAL MULTI-DOSE VIAL
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name ROFERON A
Proper Name INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103145 0 1 641986 3 MIU05 ML ( 3 MIU05 ML ) 06012009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name ZENAPAX
Proper Name DACLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103749 0 1 12101997 25 MG5 ML ( 25 MG5 ML ) 07072011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No KADMON PHARMACEUTICALS LLC 1867
Trade Name INFERGEN
Proper Name INTERFERON ALFACON-1
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103663 0 1 1061997 9 MCG03 ML ( 30 MCGML ) 07252013
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 5 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103770 0 3 6191998 50 MGVIAL ( 50 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
103770 0 4 6191998 100 MGVIAL ( 100 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name INTRON A
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103132 0 6 641986 10 MIUML ( 10 MIUML ) 09232013
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103132 0 7 641986 225 MIU15 ML ( 225 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 8 641986 375 MIU15 ML ( 375 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 9 641986 75 MIU15 ML ( 75 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103949 0 5 1192001 675 MCGPEN ( 675 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 6 1192001 108 MCGPEN ( 108 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
March 2018 Page 6 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name PEGINTRON
103949 0 7 1192001 1184 MCGVIAL ( 1184 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 8 1192001 162 MCGPEN ( 162 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 9 1192001 1776 MCGVIAL ( 1776 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 10 1192001 2025 MCGPEN ( 2025 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 11 1192001 222 MCGVIAL ( 222 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No PALATIN TECHNOLOGIES INC 1588
Trade Name NEUTROSPEC TECHNETIUM (99M TC)
Proper Name FANOLESOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103928 0 1 722004 025 MGVIAL ( 025 MGVIAL ) 09222008
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No RECORDATI RARE DISEASES INC 1899
Trade Name ELSPAR
Proper Name ASPARAGINASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
101063 0 1 1101978 10000 IU ( 10000 IUVIAL ) 04092014
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
March 2018 Page 7 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No SCHERING CORP 0994
Trade Name PEGINTRONREBETOL COMBO PACK
Proper Name PEGINTERFERON ALFA-2B AND RIBAVIRIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125196 0 1 6132008 ( 4 (120 MCG05ML) REDIPEN amp 140 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 2 6132008 ( 4 (150 MCG05ML) REDIPEN amp 168 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 3 6132008 ( 4 (150 MCG05ML) REDIPEN amp 196 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 4 6132008 ( 4 (50 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 5 6132008 ( 4 (80 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125422 0 2 10172012 05 MG ( 25 MGML ) 08082017
SOLUTION INTRAVETREAL SINGLE-DOSE VIAL
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125164 0 10 11142007 50 MCGML ( 50 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 8 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
125164 0 11 11142007 100 MCGML ( 100 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 12 11142007 200 MCGML ( 200 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 13 11142007 300 MCGML ( 300 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 14 11142007 400 MCGML ( 400 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 15 11142007 400 MCG06 ML ( 400 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 16 11142007 600 MCGML ( 600 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 17 11142007 600 MCG06 ML ( 600 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 18 11142007 800 MCG06 ML ( 800 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 19 11142007 1000 MCGML ( 1000 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 9 of 9
CDER Billable Biologic Product List
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Proper Name PEG-INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103964 0 1 10162002 180 MCGML ( 180 MCGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
103964 0 2 10162002 180 MCG05 ML ( 360 MCGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
103964 5204 3 9292011 135 MCG05 ML ( 270 MCGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
ApplicantLicense No HORIZON PHARMA IRELAND LTD 2022
Trade Name ACTIMMUNE
Proper Name INTERFERON GAMMA-1B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103836 0 1 2251999 100 MCG05 ML ( 200 MCGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No HORIZON PHARMA RHEUMATOLOGY LLC 1998
Trade Name KRYSTEXXA
Proper Name PEGLOTICASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125293 0 1 9142010 8MGML ( 8MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 24 of 42
CDER Billable Biologic Product List
ApplicantLicense No HUMAN GENOME SCIENCES INC 1820
Trade Name BENLYSTA
Proper Name BELIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125370 0 1 392011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
120 MG ( 120 MGVIAL )
125370 0 2 392011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
400 MG ( 400 MGVIAL )
125370 0 3 392011
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )
125370 0 4 392011
SOLUTION SUBCUTANEOUS AUTOINJECTOR
200 MGML ( 200 MGML )
BLASTN
761043 0
Product
1
Approval Date
7202017
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )
Trade Name
Proper Name
RAXIBACUMAB
RAXIBACUMAB
BLASTN
125349 0
Product
1
Approval Date
12142012
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1700 MG34 ML ( 50 MGML )
ApplicantLicense No IMCLONE LLC 1695
Trade Name ERBITUX
Proper Name CETUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125084 0 1 2122004 100 MG50 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 25 of 42
CDER Billable Biologic Product List
ApplicantLicense No IMCLONE LLC 1695
125084 0 2 2122004 200 MG100 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No IMMUNEX CORP 1132
Trade Name ENBREL
Proper Name ETANERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103795 0 1 1121998
POWDER SUBCUTANEOUS MULTI-DOSE VIAL
25 MG ( 25 MGVIAL )
103795 5184 2 9272004
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
50 MGML ( 50 MGML )
103795 0 3 9272004
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MGML ( 50 MGML )
103795 5184 4 9272004
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
25 MG05 ML ( 50 MGML )
103795 5556 5 9142017
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MGML ( 50 MGML )
ApplicantLicense No IPSEN BIOPHARM LIMITED 1787
Trade Name DYSPORT
Proper Name ABOBOTULINUMTOXINA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125274 0 1 4292009
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
300 UNITS ( 300 UNITSVIAL )
125274 0 2 4292009
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
500 UNITS ( 500 UNITSVIAL )
March 2018 Page 26 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
Trade Name DARZALEX
Proper Name DARATUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761036 0 1 11162015
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG5 ML ( 20 MGML )
761036 0 2 11162015
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
400 MG20 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
103772 0
REMICADE
INFLIXIMAB
Approval Date Product
8241998 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
BLASTN
103575 0
REOPRO
ABCIXIMAB
Approval Date Product
12221994 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
10 MG5 ML ( 2 MGML )
Trade Name
Proper Name
BLASTN
125289 0
SIMPONI
GOLIMUMAB
Approval Date Product
4242009 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
50 MG05 ML ( 100 MGML )
125289 0 2 4242009
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MG05 ML ( 100 MGML )
125289 0 3 4242009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
100 MGML ( 100 MGML )
March 2018 Page 27 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
125289 0 4 4242009 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name SIMPONI ARIA
Proper Name GOLIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125433 0 1 7182013 50 MG4 ML ( 125 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name STELARA
Proper Name USTEKINUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125261 0 1 9252009 90 MGML ( 90 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125261 0 2 9252009 45 MG05 ML ( 90 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL amp PREFILLED SYRINGE
125261 0 3 9252009 130 MG26 ML ( 5 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761044 0 1 9232016 130 MG26 ML ( 5 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SYLVANT
Proper Name SILTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125496 0 1 4232014 100 MG ( 100 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125496 0 2 4232014 400 MG ( 400 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 28 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
Trade Name TREMFYA
Proper Name GUSELKUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761061 0 1 7132017 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No JAZZ PHARMACEUTICALS INC 1901
Trade Name ERWINAZE
Proper Name ASPARAGINASE ERWINIA CHRYSANTHEMI
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
105359 0 1 11182011 10000 IU ( 10000 IUVIAL )
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103770 0 1 6191998
SOLUTION INTRAMUSCULAR
50 MG05 ML ( 100 MGML )
SINGLE-DOSE VIAL
103770 0 2 6191998
SOLUTION INTRAMUSCULAR
100 MGML ( 100 MGML )
SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name ILUMYA
Proper Name TILDRAKIZUMAB-ASMN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761067 0 1 3202018 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name INTRON A
March 2018 Page 29 of 42
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103132 0 1 641986 10 MIU ( 10 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL INTRAVENOUS SINGLE-DOSE VIAL
103132 0 2 641986 18 MIU ( 18 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL
103132 0 3 641986 50 MIU ( 50 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL
103132 0 4 641986 228 MIU38 ML ( 6 MIUML )
SOLUTION INTRAMUSCULAR SUBCUTANEOUS MULTI-DOSE VIAL
103132 0 5 641986 32 MIU32 ML ( 10 MIUML )
SOLUTION INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL MULTI-DOSE VIAL
Trade Name KEYTRUDA
Proper Name PEMBROLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125514 0 1 942014 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125514 1 2 1152015 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 0 1 1192001 74 MCG ( 74 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SYLATRON
Proper Name PEGINTERFERON ALFA-2B
March 2018 Page 30 of 42
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 5153 2 3292011 296 MCG ( 296 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 3 3292011 444 MCG ( 444 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 4 3292011 888 MCG ( 888 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name ZINPLAVA
Proper Name BEZLOTOXUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761046 0 1 10212016 1000 MG40 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No MERZ PHARMACEUTICALS GMBH 1830
Trade Name XEOMIN
Proper Name INCOBOTULINUMTOXINA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125360 0 1 7302010
POWDER INTRAMUSCULAR
50 U ( 50 UVIAL )
SINGLE-DOSE VIAL
125360 0 2 7302010
POWDER INTRAMUSCULAR
100 U ( 100 UVIAL )
SINGLE-DOSE VIAL
125360 3 3 11202015
POWDER INTRAMUSCULAR
200 U ( 200 UVIAL )
SINGLE-DOSE VIAL
March 2018 Page 31 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
Trade Name ARZERRA
Proper Name OFATUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125326 0 1 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG5 ML ( 20 MGML )
125326 0 2 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1000 MG50 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
125504 0
COSENTYX
SECUKINUMAB
Approval Date Product
1212015 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
150 MG ( 150 MGVIAL )
125504 0 2 1212015
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MGML ( 150 MGML )
125504 0 3 1212015
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MGML ( 150 MGML )
Trade Name
Proper Name
BLASTN
125290 0
EXTAVIA
INTERFERON BETA-1B
Approval Date Product
8142009 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
03 MG ( 03 MGVIAL )
Trade Name
Proper Name
BLASTN
125319 0
ILARIS
CANAKINUMAB
Approval Date Product
6172009 1
PotencyDosage FormRoutePresentation
180 MGVIAL ( 180 MGVIAL )
March 2018 Page 32 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
125319 88 2 12222016 150 MG ( 150 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
125319 0 3 12222016 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SIMULECT
Proper Name BASILIXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103764 0 1 5121998 10 MG ( 10 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
103764 0 2 5121998 20 MG ( 20 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No NPS PHARMACEUTICALS INC 1908
Trade Name NATPARA
Proper Name PARATHYROID HORMONE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 33 of 42
CDER Billable Biologic Product List
ApplicantLicense No PROMETHEUS LABORATORIES INC 1848
Trade Name PROLEUKIN
Proper Name ALDESLEUKIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103293 0 1 551992 22 MIU ( 22 MIUVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760
Trade Name ARCALYST
Proper Name RILONACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125249 0 1 2272008
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
220MG ( 220MGVIAL )
Trade Name
Proper Name
DUPIXENT
DUPILUMAB
BLASTN
761055 0
Product
1
Approval Date
3282017
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
300 MG2 ML ( 150 MGML )
Trade Name
Proper Name
EYLEA
AFLIBERCEPT
BLASTN
125387 0
Product
1
Approval Date
11182011
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
2 MG005 ML ( 40 MGML )
March 2018 Page 34 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Trade Name ELITEK
Proper Name RASBURICASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103946 0 1 7122002
POWDER INTRAVENOUS SINGLE-DOSE VIAL
15 MG ( 15 MGVIAL )
103946 5020 2 162006
POWDER INTRAVENOUS SINGLE-DOSE VIAL
75 MG ( 75 MGVIAL )
Trade Name
Proper Name
BLASTN
761037 0
KEVZARA
SARILUMAB
Approval Date Product
5222017 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MG114 ML ( 13158 MGML )
761037 0 2 5222017
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MG114 ML ( 17544 MGML )
761037 1 3 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MG114 ML ( 13158 MGML )
761037 1 4 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
200 MG114 ML ( 17544 MGML )
Trade Name
Proper Name
BLASTN
103362 0
LEUKINE
SARGRAMOSTIM
Approval Date Product
351991 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
250 MCG ( 250 MCGVIAL )
103362 0 2 351991
SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL
500 MCGML ( 500 MCGML )
Trade Name PRALUENT
March 2018 Page 35 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Proper Name ALIROCUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125559 0 1 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 2 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 3 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125559 0 4 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name ZALTRAP
Proper Name ZIV-AFLIBERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125418 0 1 832012 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125418 0 2 832012 200 MG8 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SEATTLE GENETICS INC 1853
Trade Name ADCETRIS
Proper Name BRENTUXIMAB VEDOTIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125388 1 1 8192011 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 36 of 42
CDER Billable Biologic Product List
ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593
Trade Name ELAPRASE
Proper Name IDURSULFASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125151 0 1 7242006 6 MG3 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SICOR BIOTECH UAB 1803
Trade Name GRANIX
Proper Name TBO-FILGRASTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125294 0 1 8292012
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
300 MCG0 5 ML ( 600 MCGML )
125294 0 2 8292012
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
480 MCG08 ML ( 600 MCGML )
ApplicantLicense No SMITH AND NEPHEW INC 2004
Trade Name REGRANEX
Proper Name BECAPLERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103691 0 1 12161997
GEL TOPICAL
100 UG ( 100 UGGM )
Trade Name
Proper Name
SANTYL
COLLAGENASE
BLASTN
101995 0
Product
1
Approval Date
641965
PotencyDosage FormRoutePresentation
OINTMENT TOPICAL
30 G amp 90 G TUBE ( 250 UGRAM )
March 2018 Page 37 of 42
CDER Billable Biologic Product List
ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718
Trade Name MYOBLOC
Proper Name RIMABOTULINUM TOXIN B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103846 0 1 1282002
SOLUTION INTRAMUSCULAR
2500 IU05 ML ( 5000 IUML )
SINGLE-DOSE VIAL
103846 0 3 1282002
SOLUTION INTRAMUSCULAR
10000 IU2 ML ( 5000 IUML )
SINGLE-DOSE VIAL
Proper Name RIMABOTULINUMTOXINB
BLASTN
103846 0
Product
2
Approval Date
1282002
PotencyDosage FormRoutePresentation
SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL
5000 IUML ( 5000 IUML )
ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832
Trade Name ZEVALIN
Proper Name IBRITUMOMAB TIUXETAN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125019 0 1 2192002 32 MG2 ML ( 16 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
Trade Name KEPIVANCE
Proper Name PALIFERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125103 0 1 12152004 625 MG ( 625 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name KINERET
Proper Name ANAKINRA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 38 of 42
CDER Billable Biologic Product List
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898
Trade Name ENTYVIO
Proper Name VEDOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125476 0 1 5202014 300 MG ( 300 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No TEVA RESPIRATORY LLC 2047
Trade Name CINQAIR
Proper Name RESLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761033 0 1 3232016 100 MG10 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No THERATECHNOLOGIES INC 2091
Trade Name TROGARZO
Proper Name IBALIZUMAB-UIYK
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761065 0 1 362018 200 MG133 ML ( 150 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 39 of 42
CDER Billable Biologic Product List
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
0375 MG03 ML ( 125 MGML )2222017 125422 038 1
ApplicantLicense No UCB INC 1736
Trade Name CIMZIA
Proper Name CERTOLIZUMAB PEGOL
BLASTN Approval Date PotencyDosage FormRoutePresentation Product
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
200 MG ( 200 MGVIAL ) 4222008 125160 0 1
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )5132009 125160 080 2
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
Trade Name CRYSVITA
Proper Name BUROSUMAB-TWZA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761068 0 1 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
10 MGML ( 10 MGML )
761068 0 2 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
20 MGML ( 20 MGML )
761068 0
Trade Name
Proper Name
BLASTN
March 2018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML ) 4172018 3
MEPSEVII
VESTRONIDASE ALFA-VJBK
Approval Date PotencyDosage FormRoutePresentation Product
Page 40 of 42
CDER Billable Biologic Product List
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
761047 0 1 11152017 10 MG5 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No UNITED THERAPEUTICS CORP 1993
Trade Name UNITUXIN
Proper Name DINUTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125516 0 1 3102015 175 MG5 ML ( 35 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053
Trade Name SILIQ
Proper Name BRODALUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761032 0 1 2152017 210 MG15 ML ( 140 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 41 of 42
CDER Billable Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No WYETH PHARMACEUTICALS INC 0003
Trade Name BESPONSA
Proper Name INOTUZUMAB OZOGAMICIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761040 0 1 8172017 09 MG ( 09 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 42 of 42
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 1 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
9172001 103951 0 26
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
200 MCGML ( 200 MCGML ) 09272012
103951 0 27 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
200 MCG04 ML ( 500 MCGML ) 09272012
103951 0 28 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
300 MCGML ( 300 MCGML ) 09272012
103951 0 29 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
300 MCG06 ML ( 500 MCGML ) 09272012
103951 0 30 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
500 MCGML ( 500 MCGML ) 09272012
ApplicantLicense No ASTELLAS PHARMACEUTICALS US INC 1748
Trade Name AMEVIVE
Proper Name ALEFACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125036 0 1 1302003 75 MGVIAL ( 75 MGVIAL ) 09242008
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
125036 0 2 1302003 15 MGVIAL ( 15 MGVIAL ) 09282012
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No BOEHRINGER INGELHEIM PHARMA KG 1251
Trade Name VERLUMA
Proper Name NOFETUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103769 0 1 10131998 10 MGML ( 10 MGML ) 08132013
INTRAVENOUS
March 2018 Page 2 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No CENTOCOR ORTHO BIOTECH PRODUCTS LP 1824
Trade Name ORTHOCLONE OKT3
Proper Name MUROMONAB-CD3
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103463 0 1 9141992 1 MGML ( 1 MGML ) 01112012
SOLUTION INTRAVENOUS AMPULE
ApplicantLicense No EISAI INCORPORATED 1862
Trade Name ONTAK
Proper Name DENILEUKIN DIFTITOX
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103767 0 1 251999 300 MCG2 ML ( 150 MCGML ) 01302014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No ELI LILLY AND CO 1611
Trade Name XIGRIS
Proper Name DROTRECOGIN ALFA (ACTIVATED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125029 0 1 11212001 5 MGVIAL ( 5 MGVIAL ) 10262011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125029 0 2 11212001 20 MGVIAL ( 20 MGVIAL ) 10102011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GENENTECH INC 1048
Trade Name RAPTIVA
Proper Name EFALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125075 0 1 10272003 125 MGVIAL ( 125 MGVIAL ) 09012009
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
March 2018 Page 3 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103976 0 2 6202003 125 MGVIAL ( 125 MGVIAL ) 08252016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103948 0 3 572001 10 MGVIAL ( 10 MGVIAL ) 07062011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name MYOZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125141 0 1 4282006 50 MGVIAL ( 50 MGVIAL ) 10172014
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name BEXXAR THERAPEUTIC REGIME
Proper Name TOSITUMOMAB AND IODINE I-131 TOSITUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125011 0 1 6272003 01 MGML I-131 TOSITUMOMAB ( 01 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 2 6272003 11 MGML I-131 TOSITUMOMAB ( 11 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 3 6272003 14 MGML TOSITUMOMAB ( 14 MGML 03102014 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 4 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No HEMISPHERX BIOPHARMA INC 1703
Trade Name ALFERON N INJECTION
Proper Name INTERFERON ALFA-N3 (HUMAN LEUKOCYTE DERIVED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103158 0 1 10101989 5 MIUVIAL ( 5 MIUVIAL ) 06272013
SOLUTION INTRALESIONAL MULTI-DOSE VIAL
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name ROFERON A
Proper Name INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103145 0 1 641986 3 MIU05 ML ( 3 MIU05 ML ) 06012009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name ZENAPAX
Proper Name DACLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103749 0 1 12101997 25 MG5 ML ( 25 MG5 ML ) 07072011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No KADMON PHARMACEUTICALS LLC 1867
Trade Name INFERGEN
Proper Name INTERFERON ALFACON-1
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103663 0 1 1061997 9 MCG03 ML ( 30 MCGML ) 07252013
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 5 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103770 0 3 6191998 50 MGVIAL ( 50 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
103770 0 4 6191998 100 MGVIAL ( 100 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name INTRON A
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103132 0 6 641986 10 MIUML ( 10 MIUML ) 09232013
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103132 0 7 641986 225 MIU15 ML ( 225 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 8 641986 375 MIU15 ML ( 375 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 9 641986 75 MIU15 ML ( 75 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103949 0 5 1192001 675 MCGPEN ( 675 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 6 1192001 108 MCGPEN ( 108 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
March 2018 Page 6 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name PEGINTRON
103949 0 7 1192001 1184 MCGVIAL ( 1184 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 8 1192001 162 MCGPEN ( 162 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 9 1192001 1776 MCGVIAL ( 1776 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 10 1192001 2025 MCGPEN ( 2025 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 11 1192001 222 MCGVIAL ( 222 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No PALATIN TECHNOLOGIES INC 1588
Trade Name NEUTROSPEC TECHNETIUM (99M TC)
Proper Name FANOLESOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103928 0 1 722004 025 MGVIAL ( 025 MGVIAL ) 09222008
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No RECORDATI RARE DISEASES INC 1899
Trade Name ELSPAR
Proper Name ASPARAGINASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
101063 0 1 1101978 10000 IU ( 10000 IUVIAL ) 04092014
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
March 2018 Page 7 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No SCHERING CORP 0994
Trade Name PEGINTRONREBETOL COMBO PACK
Proper Name PEGINTERFERON ALFA-2B AND RIBAVIRIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125196 0 1 6132008 ( 4 (120 MCG05ML) REDIPEN amp 140 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 2 6132008 ( 4 (150 MCG05ML) REDIPEN amp 168 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 3 6132008 ( 4 (150 MCG05ML) REDIPEN amp 196 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 4 6132008 ( 4 (50 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 5 6132008 ( 4 (80 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125422 0 2 10172012 05 MG ( 25 MGML ) 08082017
SOLUTION INTRAVETREAL SINGLE-DOSE VIAL
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125164 0 10 11142007 50 MCGML ( 50 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 8 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
125164 0 11 11142007 100 MCGML ( 100 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 12 11142007 200 MCGML ( 200 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 13 11142007 300 MCGML ( 300 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 14 11142007 400 MCGML ( 400 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 15 11142007 400 MCG06 ML ( 400 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 16 11142007 600 MCGML ( 600 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 17 11142007 600 MCG06 ML ( 600 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 18 11142007 800 MCG06 ML ( 800 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 19 11142007 1000 MCGML ( 1000 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 9 of 9
CDER Billable Biologic Product List
ApplicantLicense No HUMAN GENOME SCIENCES INC 1820
Trade Name BENLYSTA
Proper Name BELIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125370 0 1 392011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
120 MG ( 120 MGVIAL )
125370 0 2 392011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
400 MG ( 400 MGVIAL )
125370 0 3 392011
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )
125370 0 4 392011
SOLUTION SUBCUTANEOUS AUTOINJECTOR
200 MGML ( 200 MGML )
BLASTN
761043 0
Product
1
Approval Date
7202017
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )
Trade Name
Proper Name
RAXIBACUMAB
RAXIBACUMAB
BLASTN
125349 0
Product
1
Approval Date
12142012
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1700 MG34 ML ( 50 MGML )
ApplicantLicense No IMCLONE LLC 1695
Trade Name ERBITUX
Proper Name CETUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125084 0 1 2122004 100 MG50 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 25 of 42
CDER Billable Biologic Product List
ApplicantLicense No IMCLONE LLC 1695
125084 0 2 2122004 200 MG100 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No IMMUNEX CORP 1132
Trade Name ENBREL
Proper Name ETANERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103795 0 1 1121998
POWDER SUBCUTANEOUS MULTI-DOSE VIAL
25 MG ( 25 MGVIAL )
103795 5184 2 9272004
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
50 MGML ( 50 MGML )
103795 0 3 9272004
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MGML ( 50 MGML )
103795 5184 4 9272004
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
25 MG05 ML ( 50 MGML )
103795 5556 5 9142017
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MGML ( 50 MGML )
ApplicantLicense No IPSEN BIOPHARM LIMITED 1787
Trade Name DYSPORT
Proper Name ABOBOTULINUMTOXINA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125274 0 1 4292009
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
300 UNITS ( 300 UNITSVIAL )
125274 0 2 4292009
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
500 UNITS ( 500 UNITSVIAL )
March 2018 Page 26 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
Trade Name DARZALEX
Proper Name DARATUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761036 0 1 11162015
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG5 ML ( 20 MGML )
761036 0 2 11162015
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
400 MG20 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
103772 0
REMICADE
INFLIXIMAB
Approval Date Product
8241998 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
BLASTN
103575 0
REOPRO
ABCIXIMAB
Approval Date Product
12221994 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
10 MG5 ML ( 2 MGML )
Trade Name
Proper Name
BLASTN
125289 0
SIMPONI
GOLIMUMAB
Approval Date Product
4242009 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
50 MG05 ML ( 100 MGML )
125289 0 2 4242009
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MG05 ML ( 100 MGML )
125289 0 3 4242009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
100 MGML ( 100 MGML )
March 2018 Page 27 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
125289 0 4 4242009 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name SIMPONI ARIA
Proper Name GOLIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125433 0 1 7182013 50 MG4 ML ( 125 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name STELARA
Proper Name USTEKINUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125261 0 1 9252009 90 MGML ( 90 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125261 0 2 9252009 45 MG05 ML ( 90 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL amp PREFILLED SYRINGE
125261 0 3 9252009 130 MG26 ML ( 5 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761044 0 1 9232016 130 MG26 ML ( 5 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SYLVANT
Proper Name SILTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125496 0 1 4232014 100 MG ( 100 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125496 0 2 4232014 400 MG ( 400 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 28 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
Trade Name TREMFYA
Proper Name GUSELKUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761061 0 1 7132017 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No JAZZ PHARMACEUTICALS INC 1901
Trade Name ERWINAZE
Proper Name ASPARAGINASE ERWINIA CHRYSANTHEMI
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
105359 0 1 11182011 10000 IU ( 10000 IUVIAL )
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103770 0 1 6191998
SOLUTION INTRAMUSCULAR
50 MG05 ML ( 100 MGML )
SINGLE-DOSE VIAL
103770 0 2 6191998
SOLUTION INTRAMUSCULAR
100 MGML ( 100 MGML )
SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name ILUMYA
Proper Name TILDRAKIZUMAB-ASMN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761067 0 1 3202018 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name INTRON A
March 2018 Page 29 of 42
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103132 0 1 641986 10 MIU ( 10 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL INTRAVENOUS SINGLE-DOSE VIAL
103132 0 2 641986 18 MIU ( 18 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL
103132 0 3 641986 50 MIU ( 50 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL
103132 0 4 641986 228 MIU38 ML ( 6 MIUML )
SOLUTION INTRAMUSCULAR SUBCUTANEOUS MULTI-DOSE VIAL
103132 0 5 641986 32 MIU32 ML ( 10 MIUML )
SOLUTION INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL MULTI-DOSE VIAL
Trade Name KEYTRUDA
Proper Name PEMBROLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125514 0 1 942014 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125514 1 2 1152015 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 0 1 1192001 74 MCG ( 74 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SYLATRON
Proper Name PEGINTERFERON ALFA-2B
March 2018 Page 30 of 42
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 5153 2 3292011 296 MCG ( 296 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 3 3292011 444 MCG ( 444 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 4 3292011 888 MCG ( 888 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name ZINPLAVA
Proper Name BEZLOTOXUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761046 0 1 10212016 1000 MG40 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No MERZ PHARMACEUTICALS GMBH 1830
Trade Name XEOMIN
Proper Name INCOBOTULINUMTOXINA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125360 0 1 7302010
POWDER INTRAMUSCULAR
50 U ( 50 UVIAL )
SINGLE-DOSE VIAL
125360 0 2 7302010
POWDER INTRAMUSCULAR
100 U ( 100 UVIAL )
SINGLE-DOSE VIAL
125360 3 3 11202015
POWDER INTRAMUSCULAR
200 U ( 200 UVIAL )
SINGLE-DOSE VIAL
March 2018 Page 31 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
Trade Name ARZERRA
Proper Name OFATUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125326 0 1 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG5 ML ( 20 MGML )
125326 0 2 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1000 MG50 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
125504 0
COSENTYX
SECUKINUMAB
Approval Date Product
1212015 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
150 MG ( 150 MGVIAL )
125504 0 2 1212015
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MGML ( 150 MGML )
125504 0 3 1212015
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MGML ( 150 MGML )
Trade Name
Proper Name
BLASTN
125290 0
EXTAVIA
INTERFERON BETA-1B
Approval Date Product
8142009 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
03 MG ( 03 MGVIAL )
Trade Name
Proper Name
BLASTN
125319 0
ILARIS
CANAKINUMAB
Approval Date Product
6172009 1
PotencyDosage FormRoutePresentation
180 MGVIAL ( 180 MGVIAL )
March 2018 Page 32 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
125319 88 2 12222016 150 MG ( 150 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
125319 0 3 12222016 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SIMULECT
Proper Name BASILIXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103764 0 1 5121998 10 MG ( 10 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
103764 0 2 5121998 20 MG ( 20 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No NPS PHARMACEUTICALS INC 1908
Trade Name NATPARA
Proper Name PARATHYROID HORMONE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 33 of 42
CDER Billable Biologic Product List
ApplicantLicense No PROMETHEUS LABORATORIES INC 1848
Trade Name PROLEUKIN
Proper Name ALDESLEUKIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103293 0 1 551992 22 MIU ( 22 MIUVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760
Trade Name ARCALYST
Proper Name RILONACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125249 0 1 2272008
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
220MG ( 220MGVIAL )
Trade Name
Proper Name
DUPIXENT
DUPILUMAB
BLASTN
761055 0
Product
1
Approval Date
3282017
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
300 MG2 ML ( 150 MGML )
Trade Name
Proper Name
EYLEA
AFLIBERCEPT
BLASTN
125387 0
Product
1
Approval Date
11182011
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
2 MG005 ML ( 40 MGML )
March 2018 Page 34 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Trade Name ELITEK
Proper Name RASBURICASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103946 0 1 7122002
POWDER INTRAVENOUS SINGLE-DOSE VIAL
15 MG ( 15 MGVIAL )
103946 5020 2 162006
POWDER INTRAVENOUS SINGLE-DOSE VIAL
75 MG ( 75 MGVIAL )
Trade Name
Proper Name
BLASTN
761037 0
KEVZARA
SARILUMAB
Approval Date Product
5222017 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MG114 ML ( 13158 MGML )
761037 0 2 5222017
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MG114 ML ( 17544 MGML )
761037 1 3 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MG114 ML ( 13158 MGML )
761037 1 4 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
200 MG114 ML ( 17544 MGML )
Trade Name
Proper Name
BLASTN
103362 0
LEUKINE
SARGRAMOSTIM
Approval Date Product
351991 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
250 MCG ( 250 MCGVIAL )
103362 0 2 351991
SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL
500 MCGML ( 500 MCGML )
Trade Name PRALUENT
March 2018 Page 35 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Proper Name ALIROCUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125559 0 1 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 2 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 3 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125559 0 4 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name ZALTRAP
Proper Name ZIV-AFLIBERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125418 0 1 832012 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125418 0 2 832012 200 MG8 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SEATTLE GENETICS INC 1853
Trade Name ADCETRIS
Proper Name BRENTUXIMAB VEDOTIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125388 1 1 8192011 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 36 of 42
CDER Billable Biologic Product List
ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593
Trade Name ELAPRASE
Proper Name IDURSULFASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125151 0 1 7242006 6 MG3 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SICOR BIOTECH UAB 1803
Trade Name GRANIX
Proper Name TBO-FILGRASTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125294 0 1 8292012
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
300 MCG0 5 ML ( 600 MCGML )
125294 0 2 8292012
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
480 MCG08 ML ( 600 MCGML )
ApplicantLicense No SMITH AND NEPHEW INC 2004
Trade Name REGRANEX
Proper Name BECAPLERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103691 0 1 12161997
GEL TOPICAL
100 UG ( 100 UGGM )
Trade Name
Proper Name
SANTYL
COLLAGENASE
BLASTN
101995 0
Product
1
Approval Date
641965
PotencyDosage FormRoutePresentation
OINTMENT TOPICAL
30 G amp 90 G TUBE ( 250 UGRAM )
March 2018 Page 37 of 42
CDER Billable Biologic Product List
ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718
Trade Name MYOBLOC
Proper Name RIMABOTULINUM TOXIN B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103846 0 1 1282002
SOLUTION INTRAMUSCULAR
2500 IU05 ML ( 5000 IUML )
SINGLE-DOSE VIAL
103846 0 3 1282002
SOLUTION INTRAMUSCULAR
10000 IU2 ML ( 5000 IUML )
SINGLE-DOSE VIAL
Proper Name RIMABOTULINUMTOXINB
BLASTN
103846 0
Product
2
Approval Date
1282002
PotencyDosage FormRoutePresentation
SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL
5000 IUML ( 5000 IUML )
ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832
Trade Name ZEVALIN
Proper Name IBRITUMOMAB TIUXETAN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125019 0 1 2192002 32 MG2 ML ( 16 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
Trade Name KEPIVANCE
Proper Name PALIFERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125103 0 1 12152004 625 MG ( 625 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name KINERET
Proper Name ANAKINRA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 38 of 42
CDER Billable Biologic Product List
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898
Trade Name ENTYVIO
Proper Name VEDOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125476 0 1 5202014 300 MG ( 300 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No TEVA RESPIRATORY LLC 2047
Trade Name CINQAIR
Proper Name RESLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761033 0 1 3232016 100 MG10 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No THERATECHNOLOGIES INC 2091
Trade Name TROGARZO
Proper Name IBALIZUMAB-UIYK
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761065 0 1 362018 200 MG133 ML ( 150 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 39 of 42
CDER Billable Biologic Product List
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
0375 MG03 ML ( 125 MGML )2222017 125422 038 1
ApplicantLicense No UCB INC 1736
Trade Name CIMZIA
Proper Name CERTOLIZUMAB PEGOL
BLASTN Approval Date PotencyDosage FormRoutePresentation Product
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
200 MG ( 200 MGVIAL ) 4222008 125160 0 1
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )5132009 125160 080 2
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
Trade Name CRYSVITA
Proper Name BUROSUMAB-TWZA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761068 0 1 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
10 MGML ( 10 MGML )
761068 0 2 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
20 MGML ( 20 MGML )
761068 0
Trade Name
Proper Name
BLASTN
March 2018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML ) 4172018 3
MEPSEVII
VESTRONIDASE ALFA-VJBK
Approval Date PotencyDosage FormRoutePresentation Product
Page 40 of 42
CDER Billable Biologic Product List
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
761047 0 1 11152017 10 MG5 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No UNITED THERAPEUTICS CORP 1993
Trade Name UNITUXIN
Proper Name DINUTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125516 0 1 3102015 175 MG5 ML ( 35 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053
Trade Name SILIQ
Proper Name BRODALUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761032 0 1 2152017 210 MG15 ML ( 140 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 41 of 42
CDER Billable Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No WYETH PHARMACEUTICALS INC 0003
Trade Name BESPONSA
Proper Name INOTUZUMAB OZOGAMICIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761040 0 1 8172017 09 MG ( 09 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 42 of 42
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 1 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
9172001 103951 0 26
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
200 MCGML ( 200 MCGML ) 09272012
103951 0 27 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
200 MCG04 ML ( 500 MCGML ) 09272012
103951 0 28 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
300 MCGML ( 300 MCGML ) 09272012
103951 0 29 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
300 MCG06 ML ( 500 MCGML ) 09272012
103951 0 30 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
500 MCGML ( 500 MCGML ) 09272012
ApplicantLicense No ASTELLAS PHARMACEUTICALS US INC 1748
Trade Name AMEVIVE
Proper Name ALEFACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125036 0 1 1302003 75 MGVIAL ( 75 MGVIAL ) 09242008
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
125036 0 2 1302003 15 MGVIAL ( 15 MGVIAL ) 09282012
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No BOEHRINGER INGELHEIM PHARMA KG 1251
Trade Name VERLUMA
Proper Name NOFETUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103769 0 1 10131998 10 MGML ( 10 MGML ) 08132013
INTRAVENOUS
March 2018 Page 2 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No CENTOCOR ORTHO BIOTECH PRODUCTS LP 1824
Trade Name ORTHOCLONE OKT3
Proper Name MUROMONAB-CD3
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103463 0 1 9141992 1 MGML ( 1 MGML ) 01112012
SOLUTION INTRAVENOUS AMPULE
ApplicantLicense No EISAI INCORPORATED 1862
Trade Name ONTAK
Proper Name DENILEUKIN DIFTITOX
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103767 0 1 251999 300 MCG2 ML ( 150 MCGML ) 01302014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No ELI LILLY AND CO 1611
Trade Name XIGRIS
Proper Name DROTRECOGIN ALFA (ACTIVATED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125029 0 1 11212001 5 MGVIAL ( 5 MGVIAL ) 10262011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125029 0 2 11212001 20 MGVIAL ( 20 MGVIAL ) 10102011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GENENTECH INC 1048
Trade Name RAPTIVA
Proper Name EFALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125075 0 1 10272003 125 MGVIAL ( 125 MGVIAL ) 09012009
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
March 2018 Page 3 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103976 0 2 6202003 125 MGVIAL ( 125 MGVIAL ) 08252016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103948 0 3 572001 10 MGVIAL ( 10 MGVIAL ) 07062011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name MYOZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125141 0 1 4282006 50 MGVIAL ( 50 MGVIAL ) 10172014
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name BEXXAR THERAPEUTIC REGIME
Proper Name TOSITUMOMAB AND IODINE I-131 TOSITUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125011 0 1 6272003 01 MGML I-131 TOSITUMOMAB ( 01 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 2 6272003 11 MGML I-131 TOSITUMOMAB ( 11 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 3 6272003 14 MGML TOSITUMOMAB ( 14 MGML 03102014 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 4 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No HEMISPHERX BIOPHARMA INC 1703
Trade Name ALFERON N INJECTION
Proper Name INTERFERON ALFA-N3 (HUMAN LEUKOCYTE DERIVED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103158 0 1 10101989 5 MIUVIAL ( 5 MIUVIAL ) 06272013
SOLUTION INTRALESIONAL MULTI-DOSE VIAL
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name ROFERON A
Proper Name INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103145 0 1 641986 3 MIU05 ML ( 3 MIU05 ML ) 06012009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name ZENAPAX
Proper Name DACLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103749 0 1 12101997 25 MG5 ML ( 25 MG5 ML ) 07072011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No KADMON PHARMACEUTICALS LLC 1867
Trade Name INFERGEN
Proper Name INTERFERON ALFACON-1
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103663 0 1 1061997 9 MCG03 ML ( 30 MCGML ) 07252013
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 5 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103770 0 3 6191998 50 MGVIAL ( 50 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
103770 0 4 6191998 100 MGVIAL ( 100 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name INTRON A
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103132 0 6 641986 10 MIUML ( 10 MIUML ) 09232013
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103132 0 7 641986 225 MIU15 ML ( 225 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 8 641986 375 MIU15 ML ( 375 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 9 641986 75 MIU15 ML ( 75 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103949 0 5 1192001 675 MCGPEN ( 675 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 6 1192001 108 MCGPEN ( 108 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
March 2018 Page 6 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name PEGINTRON
103949 0 7 1192001 1184 MCGVIAL ( 1184 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 8 1192001 162 MCGPEN ( 162 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 9 1192001 1776 MCGVIAL ( 1776 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 10 1192001 2025 MCGPEN ( 2025 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 11 1192001 222 MCGVIAL ( 222 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No PALATIN TECHNOLOGIES INC 1588
Trade Name NEUTROSPEC TECHNETIUM (99M TC)
Proper Name FANOLESOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103928 0 1 722004 025 MGVIAL ( 025 MGVIAL ) 09222008
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No RECORDATI RARE DISEASES INC 1899
Trade Name ELSPAR
Proper Name ASPARAGINASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
101063 0 1 1101978 10000 IU ( 10000 IUVIAL ) 04092014
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
March 2018 Page 7 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No SCHERING CORP 0994
Trade Name PEGINTRONREBETOL COMBO PACK
Proper Name PEGINTERFERON ALFA-2B AND RIBAVIRIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125196 0 1 6132008 ( 4 (120 MCG05ML) REDIPEN amp 140 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 2 6132008 ( 4 (150 MCG05ML) REDIPEN amp 168 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 3 6132008 ( 4 (150 MCG05ML) REDIPEN amp 196 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 4 6132008 ( 4 (50 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 5 6132008 ( 4 (80 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125422 0 2 10172012 05 MG ( 25 MGML ) 08082017
SOLUTION INTRAVETREAL SINGLE-DOSE VIAL
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125164 0 10 11142007 50 MCGML ( 50 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 8 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
125164 0 11 11142007 100 MCGML ( 100 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 12 11142007 200 MCGML ( 200 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 13 11142007 300 MCGML ( 300 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 14 11142007 400 MCGML ( 400 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 15 11142007 400 MCG06 ML ( 400 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 16 11142007 600 MCGML ( 600 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 17 11142007 600 MCG06 ML ( 600 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 18 11142007 800 MCG06 ML ( 800 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 19 11142007 1000 MCGML ( 1000 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 9 of 9
CDER Billable Biologic Product List
ApplicantLicense No IMCLONE LLC 1695
125084 0 2 2122004 200 MG100 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No IMMUNEX CORP 1132
Trade Name ENBREL
Proper Name ETANERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103795 0 1 1121998
POWDER SUBCUTANEOUS MULTI-DOSE VIAL
25 MG ( 25 MGVIAL )
103795 5184 2 9272004
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
50 MGML ( 50 MGML )
103795 0 3 9272004
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MGML ( 50 MGML )
103795 5184 4 9272004
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
25 MG05 ML ( 50 MGML )
103795 5556 5 9142017
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MGML ( 50 MGML )
ApplicantLicense No IPSEN BIOPHARM LIMITED 1787
Trade Name DYSPORT
Proper Name ABOBOTULINUMTOXINA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125274 0 1 4292009
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
300 UNITS ( 300 UNITSVIAL )
125274 0 2 4292009
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
500 UNITS ( 500 UNITSVIAL )
March 2018 Page 26 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
Trade Name DARZALEX
Proper Name DARATUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761036 0 1 11162015
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG5 ML ( 20 MGML )
761036 0 2 11162015
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
400 MG20 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
103772 0
REMICADE
INFLIXIMAB
Approval Date Product
8241998 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
BLASTN
103575 0
REOPRO
ABCIXIMAB
Approval Date Product
12221994 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
10 MG5 ML ( 2 MGML )
Trade Name
Proper Name
BLASTN
125289 0
SIMPONI
GOLIMUMAB
Approval Date Product
4242009 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
50 MG05 ML ( 100 MGML )
125289 0 2 4242009
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MG05 ML ( 100 MGML )
125289 0 3 4242009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
100 MGML ( 100 MGML )
March 2018 Page 27 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
125289 0 4 4242009 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name SIMPONI ARIA
Proper Name GOLIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125433 0 1 7182013 50 MG4 ML ( 125 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name STELARA
Proper Name USTEKINUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125261 0 1 9252009 90 MGML ( 90 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125261 0 2 9252009 45 MG05 ML ( 90 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL amp PREFILLED SYRINGE
125261 0 3 9252009 130 MG26 ML ( 5 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761044 0 1 9232016 130 MG26 ML ( 5 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SYLVANT
Proper Name SILTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125496 0 1 4232014 100 MG ( 100 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125496 0 2 4232014 400 MG ( 400 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 28 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
Trade Name TREMFYA
Proper Name GUSELKUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761061 0 1 7132017 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No JAZZ PHARMACEUTICALS INC 1901
Trade Name ERWINAZE
Proper Name ASPARAGINASE ERWINIA CHRYSANTHEMI
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
105359 0 1 11182011 10000 IU ( 10000 IUVIAL )
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103770 0 1 6191998
SOLUTION INTRAMUSCULAR
50 MG05 ML ( 100 MGML )
SINGLE-DOSE VIAL
103770 0 2 6191998
SOLUTION INTRAMUSCULAR
100 MGML ( 100 MGML )
SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name ILUMYA
Proper Name TILDRAKIZUMAB-ASMN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761067 0 1 3202018 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name INTRON A
March 2018 Page 29 of 42
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103132 0 1 641986 10 MIU ( 10 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL INTRAVENOUS SINGLE-DOSE VIAL
103132 0 2 641986 18 MIU ( 18 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL
103132 0 3 641986 50 MIU ( 50 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL
103132 0 4 641986 228 MIU38 ML ( 6 MIUML )
SOLUTION INTRAMUSCULAR SUBCUTANEOUS MULTI-DOSE VIAL
103132 0 5 641986 32 MIU32 ML ( 10 MIUML )
SOLUTION INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL MULTI-DOSE VIAL
Trade Name KEYTRUDA
Proper Name PEMBROLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125514 0 1 942014 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125514 1 2 1152015 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 0 1 1192001 74 MCG ( 74 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SYLATRON
Proper Name PEGINTERFERON ALFA-2B
March 2018 Page 30 of 42
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 5153 2 3292011 296 MCG ( 296 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 3 3292011 444 MCG ( 444 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 4 3292011 888 MCG ( 888 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name ZINPLAVA
Proper Name BEZLOTOXUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761046 0 1 10212016 1000 MG40 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No MERZ PHARMACEUTICALS GMBH 1830
Trade Name XEOMIN
Proper Name INCOBOTULINUMTOXINA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125360 0 1 7302010
POWDER INTRAMUSCULAR
50 U ( 50 UVIAL )
SINGLE-DOSE VIAL
125360 0 2 7302010
POWDER INTRAMUSCULAR
100 U ( 100 UVIAL )
SINGLE-DOSE VIAL
125360 3 3 11202015
POWDER INTRAMUSCULAR
200 U ( 200 UVIAL )
SINGLE-DOSE VIAL
March 2018 Page 31 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
Trade Name ARZERRA
Proper Name OFATUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125326 0 1 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG5 ML ( 20 MGML )
125326 0 2 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1000 MG50 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
125504 0
COSENTYX
SECUKINUMAB
Approval Date Product
1212015 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
150 MG ( 150 MGVIAL )
125504 0 2 1212015
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MGML ( 150 MGML )
125504 0 3 1212015
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MGML ( 150 MGML )
Trade Name
Proper Name
BLASTN
125290 0
EXTAVIA
INTERFERON BETA-1B
Approval Date Product
8142009 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
03 MG ( 03 MGVIAL )
Trade Name
Proper Name
BLASTN
125319 0
ILARIS
CANAKINUMAB
Approval Date Product
6172009 1
PotencyDosage FormRoutePresentation
180 MGVIAL ( 180 MGVIAL )
March 2018 Page 32 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
125319 88 2 12222016 150 MG ( 150 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
125319 0 3 12222016 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SIMULECT
Proper Name BASILIXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103764 0 1 5121998 10 MG ( 10 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
103764 0 2 5121998 20 MG ( 20 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No NPS PHARMACEUTICALS INC 1908
Trade Name NATPARA
Proper Name PARATHYROID HORMONE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 33 of 42
CDER Billable Biologic Product List
ApplicantLicense No PROMETHEUS LABORATORIES INC 1848
Trade Name PROLEUKIN
Proper Name ALDESLEUKIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103293 0 1 551992 22 MIU ( 22 MIUVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760
Trade Name ARCALYST
Proper Name RILONACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125249 0 1 2272008
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
220MG ( 220MGVIAL )
Trade Name
Proper Name
DUPIXENT
DUPILUMAB
BLASTN
761055 0
Product
1
Approval Date
3282017
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
300 MG2 ML ( 150 MGML )
Trade Name
Proper Name
EYLEA
AFLIBERCEPT
BLASTN
125387 0
Product
1
Approval Date
11182011
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
2 MG005 ML ( 40 MGML )
March 2018 Page 34 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Trade Name ELITEK
Proper Name RASBURICASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103946 0 1 7122002
POWDER INTRAVENOUS SINGLE-DOSE VIAL
15 MG ( 15 MGVIAL )
103946 5020 2 162006
POWDER INTRAVENOUS SINGLE-DOSE VIAL
75 MG ( 75 MGVIAL )
Trade Name
Proper Name
BLASTN
761037 0
KEVZARA
SARILUMAB
Approval Date Product
5222017 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MG114 ML ( 13158 MGML )
761037 0 2 5222017
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MG114 ML ( 17544 MGML )
761037 1 3 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MG114 ML ( 13158 MGML )
761037 1 4 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
200 MG114 ML ( 17544 MGML )
Trade Name
Proper Name
BLASTN
103362 0
LEUKINE
SARGRAMOSTIM
Approval Date Product
351991 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
250 MCG ( 250 MCGVIAL )
103362 0 2 351991
SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL
500 MCGML ( 500 MCGML )
Trade Name PRALUENT
March 2018 Page 35 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Proper Name ALIROCUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125559 0 1 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 2 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 3 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125559 0 4 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name ZALTRAP
Proper Name ZIV-AFLIBERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125418 0 1 832012 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125418 0 2 832012 200 MG8 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SEATTLE GENETICS INC 1853
Trade Name ADCETRIS
Proper Name BRENTUXIMAB VEDOTIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125388 1 1 8192011 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 36 of 42
CDER Billable Biologic Product List
ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593
Trade Name ELAPRASE
Proper Name IDURSULFASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125151 0 1 7242006 6 MG3 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SICOR BIOTECH UAB 1803
Trade Name GRANIX
Proper Name TBO-FILGRASTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125294 0 1 8292012
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
300 MCG0 5 ML ( 600 MCGML )
125294 0 2 8292012
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
480 MCG08 ML ( 600 MCGML )
ApplicantLicense No SMITH AND NEPHEW INC 2004
Trade Name REGRANEX
Proper Name BECAPLERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103691 0 1 12161997
GEL TOPICAL
100 UG ( 100 UGGM )
Trade Name
Proper Name
SANTYL
COLLAGENASE
BLASTN
101995 0
Product
1
Approval Date
641965
PotencyDosage FormRoutePresentation
OINTMENT TOPICAL
30 G amp 90 G TUBE ( 250 UGRAM )
March 2018 Page 37 of 42
CDER Billable Biologic Product List
ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718
Trade Name MYOBLOC
Proper Name RIMABOTULINUM TOXIN B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103846 0 1 1282002
SOLUTION INTRAMUSCULAR
2500 IU05 ML ( 5000 IUML )
SINGLE-DOSE VIAL
103846 0 3 1282002
SOLUTION INTRAMUSCULAR
10000 IU2 ML ( 5000 IUML )
SINGLE-DOSE VIAL
Proper Name RIMABOTULINUMTOXINB
BLASTN
103846 0
Product
2
Approval Date
1282002
PotencyDosage FormRoutePresentation
SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL
5000 IUML ( 5000 IUML )
ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832
Trade Name ZEVALIN
Proper Name IBRITUMOMAB TIUXETAN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125019 0 1 2192002 32 MG2 ML ( 16 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
Trade Name KEPIVANCE
Proper Name PALIFERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125103 0 1 12152004 625 MG ( 625 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name KINERET
Proper Name ANAKINRA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 38 of 42
CDER Billable Biologic Product List
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898
Trade Name ENTYVIO
Proper Name VEDOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125476 0 1 5202014 300 MG ( 300 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No TEVA RESPIRATORY LLC 2047
Trade Name CINQAIR
Proper Name RESLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761033 0 1 3232016 100 MG10 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No THERATECHNOLOGIES INC 2091
Trade Name TROGARZO
Proper Name IBALIZUMAB-UIYK
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761065 0 1 362018 200 MG133 ML ( 150 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 39 of 42
CDER Billable Biologic Product List
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
0375 MG03 ML ( 125 MGML )2222017 125422 038 1
ApplicantLicense No UCB INC 1736
Trade Name CIMZIA
Proper Name CERTOLIZUMAB PEGOL
BLASTN Approval Date PotencyDosage FormRoutePresentation Product
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
200 MG ( 200 MGVIAL ) 4222008 125160 0 1
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )5132009 125160 080 2
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
Trade Name CRYSVITA
Proper Name BUROSUMAB-TWZA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761068 0 1 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
10 MGML ( 10 MGML )
761068 0 2 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
20 MGML ( 20 MGML )
761068 0
Trade Name
Proper Name
BLASTN
March 2018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML ) 4172018 3
MEPSEVII
VESTRONIDASE ALFA-VJBK
Approval Date PotencyDosage FormRoutePresentation Product
Page 40 of 42
CDER Billable Biologic Product List
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
761047 0 1 11152017 10 MG5 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No UNITED THERAPEUTICS CORP 1993
Trade Name UNITUXIN
Proper Name DINUTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125516 0 1 3102015 175 MG5 ML ( 35 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053
Trade Name SILIQ
Proper Name BRODALUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761032 0 1 2152017 210 MG15 ML ( 140 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 41 of 42
CDER Billable Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No WYETH PHARMACEUTICALS INC 0003
Trade Name BESPONSA
Proper Name INOTUZUMAB OZOGAMICIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761040 0 1 8172017 09 MG ( 09 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 42 of 42
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 1 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
9172001 103951 0 26
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
200 MCGML ( 200 MCGML ) 09272012
103951 0 27 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
200 MCG04 ML ( 500 MCGML ) 09272012
103951 0 28 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
300 MCGML ( 300 MCGML ) 09272012
103951 0 29 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
300 MCG06 ML ( 500 MCGML ) 09272012
103951 0 30 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
500 MCGML ( 500 MCGML ) 09272012
ApplicantLicense No ASTELLAS PHARMACEUTICALS US INC 1748
Trade Name AMEVIVE
Proper Name ALEFACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125036 0 1 1302003 75 MGVIAL ( 75 MGVIAL ) 09242008
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
125036 0 2 1302003 15 MGVIAL ( 15 MGVIAL ) 09282012
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No BOEHRINGER INGELHEIM PHARMA KG 1251
Trade Name VERLUMA
Proper Name NOFETUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103769 0 1 10131998 10 MGML ( 10 MGML ) 08132013
INTRAVENOUS
March 2018 Page 2 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No CENTOCOR ORTHO BIOTECH PRODUCTS LP 1824
Trade Name ORTHOCLONE OKT3
Proper Name MUROMONAB-CD3
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103463 0 1 9141992 1 MGML ( 1 MGML ) 01112012
SOLUTION INTRAVENOUS AMPULE
ApplicantLicense No EISAI INCORPORATED 1862
Trade Name ONTAK
Proper Name DENILEUKIN DIFTITOX
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103767 0 1 251999 300 MCG2 ML ( 150 MCGML ) 01302014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No ELI LILLY AND CO 1611
Trade Name XIGRIS
Proper Name DROTRECOGIN ALFA (ACTIVATED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125029 0 1 11212001 5 MGVIAL ( 5 MGVIAL ) 10262011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125029 0 2 11212001 20 MGVIAL ( 20 MGVIAL ) 10102011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GENENTECH INC 1048
Trade Name RAPTIVA
Proper Name EFALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125075 0 1 10272003 125 MGVIAL ( 125 MGVIAL ) 09012009
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
March 2018 Page 3 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103976 0 2 6202003 125 MGVIAL ( 125 MGVIAL ) 08252016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103948 0 3 572001 10 MGVIAL ( 10 MGVIAL ) 07062011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name MYOZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125141 0 1 4282006 50 MGVIAL ( 50 MGVIAL ) 10172014
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name BEXXAR THERAPEUTIC REGIME
Proper Name TOSITUMOMAB AND IODINE I-131 TOSITUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125011 0 1 6272003 01 MGML I-131 TOSITUMOMAB ( 01 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 2 6272003 11 MGML I-131 TOSITUMOMAB ( 11 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 3 6272003 14 MGML TOSITUMOMAB ( 14 MGML 03102014 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 4 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No HEMISPHERX BIOPHARMA INC 1703
Trade Name ALFERON N INJECTION
Proper Name INTERFERON ALFA-N3 (HUMAN LEUKOCYTE DERIVED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103158 0 1 10101989 5 MIUVIAL ( 5 MIUVIAL ) 06272013
SOLUTION INTRALESIONAL MULTI-DOSE VIAL
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name ROFERON A
Proper Name INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103145 0 1 641986 3 MIU05 ML ( 3 MIU05 ML ) 06012009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name ZENAPAX
Proper Name DACLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103749 0 1 12101997 25 MG5 ML ( 25 MG5 ML ) 07072011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No KADMON PHARMACEUTICALS LLC 1867
Trade Name INFERGEN
Proper Name INTERFERON ALFACON-1
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103663 0 1 1061997 9 MCG03 ML ( 30 MCGML ) 07252013
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 5 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103770 0 3 6191998 50 MGVIAL ( 50 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
103770 0 4 6191998 100 MGVIAL ( 100 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name INTRON A
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103132 0 6 641986 10 MIUML ( 10 MIUML ) 09232013
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103132 0 7 641986 225 MIU15 ML ( 225 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 8 641986 375 MIU15 ML ( 375 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 9 641986 75 MIU15 ML ( 75 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103949 0 5 1192001 675 MCGPEN ( 675 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 6 1192001 108 MCGPEN ( 108 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
March 2018 Page 6 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name PEGINTRON
103949 0 7 1192001 1184 MCGVIAL ( 1184 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 8 1192001 162 MCGPEN ( 162 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 9 1192001 1776 MCGVIAL ( 1776 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 10 1192001 2025 MCGPEN ( 2025 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 11 1192001 222 MCGVIAL ( 222 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No PALATIN TECHNOLOGIES INC 1588
Trade Name NEUTROSPEC TECHNETIUM (99M TC)
Proper Name FANOLESOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103928 0 1 722004 025 MGVIAL ( 025 MGVIAL ) 09222008
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No RECORDATI RARE DISEASES INC 1899
Trade Name ELSPAR
Proper Name ASPARAGINASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
101063 0 1 1101978 10000 IU ( 10000 IUVIAL ) 04092014
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
March 2018 Page 7 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No SCHERING CORP 0994
Trade Name PEGINTRONREBETOL COMBO PACK
Proper Name PEGINTERFERON ALFA-2B AND RIBAVIRIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125196 0 1 6132008 ( 4 (120 MCG05ML) REDIPEN amp 140 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 2 6132008 ( 4 (150 MCG05ML) REDIPEN amp 168 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 3 6132008 ( 4 (150 MCG05ML) REDIPEN amp 196 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 4 6132008 ( 4 (50 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 5 6132008 ( 4 (80 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125422 0 2 10172012 05 MG ( 25 MGML ) 08082017
SOLUTION INTRAVETREAL SINGLE-DOSE VIAL
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125164 0 10 11142007 50 MCGML ( 50 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 8 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
125164 0 11 11142007 100 MCGML ( 100 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 12 11142007 200 MCGML ( 200 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 13 11142007 300 MCGML ( 300 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 14 11142007 400 MCGML ( 400 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 15 11142007 400 MCG06 ML ( 400 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 16 11142007 600 MCGML ( 600 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 17 11142007 600 MCG06 ML ( 600 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 18 11142007 800 MCG06 ML ( 800 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 19 11142007 1000 MCGML ( 1000 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 9 of 9
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
Trade Name DARZALEX
Proper Name DARATUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761036 0 1 11162015
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG5 ML ( 20 MGML )
761036 0 2 11162015
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
400 MG20 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
103772 0
REMICADE
INFLIXIMAB
Approval Date Product
8241998 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUS SINGLE-DOSE VIAL
100 MG ( 100 MGVIAL )
Trade Name
Proper Name
BLASTN
103575 0
REOPRO
ABCIXIMAB
Approval Date Product
12221994 1
PotencyDosage FormRoutePresentation
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
10 MG5 ML ( 2 MGML )
Trade Name
Proper Name
BLASTN
125289 0
SIMPONI
GOLIMUMAB
Approval Date Product
4242009 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
50 MG05 ML ( 100 MGML )
125289 0 2 4242009
SOLUTION SUBCUTANEOUS AUTOINJECTOR
50 MG05 ML ( 100 MGML )
125289 0 3 4242009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
100 MGML ( 100 MGML )
March 2018 Page 27 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
125289 0 4 4242009 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name SIMPONI ARIA
Proper Name GOLIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125433 0 1 7182013 50 MG4 ML ( 125 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name STELARA
Proper Name USTEKINUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125261 0 1 9252009 90 MGML ( 90 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125261 0 2 9252009 45 MG05 ML ( 90 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL amp PREFILLED SYRINGE
125261 0 3 9252009 130 MG26 ML ( 5 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761044 0 1 9232016 130 MG26 ML ( 5 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SYLVANT
Proper Name SILTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125496 0 1 4232014 100 MG ( 100 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125496 0 2 4232014 400 MG ( 400 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 28 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
Trade Name TREMFYA
Proper Name GUSELKUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761061 0 1 7132017 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No JAZZ PHARMACEUTICALS INC 1901
Trade Name ERWINAZE
Proper Name ASPARAGINASE ERWINIA CHRYSANTHEMI
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
105359 0 1 11182011 10000 IU ( 10000 IUVIAL )
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103770 0 1 6191998
SOLUTION INTRAMUSCULAR
50 MG05 ML ( 100 MGML )
SINGLE-DOSE VIAL
103770 0 2 6191998
SOLUTION INTRAMUSCULAR
100 MGML ( 100 MGML )
SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name ILUMYA
Proper Name TILDRAKIZUMAB-ASMN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761067 0 1 3202018 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name INTRON A
March 2018 Page 29 of 42
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103132 0 1 641986 10 MIU ( 10 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL INTRAVENOUS SINGLE-DOSE VIAL
103132 0 2 641986 18 MIU ( 18 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL
103132 0 3 641986 50 MIU ( 50 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL
103132 0 4 641986 228 MIU38 ML ( 6 MIUML )
SOLUTION INTRAMUSCULAR SUBCUTANEOUS MULTI-DOSE VIAL
103132 0 5 641986 32 MIU32 ML ( 10 MIUML )
SOLUTION INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL MULTI-DOSE VIAL
Trade Name KEYTRUDA
Proper Name PEMBROLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125514 0 1 942014 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125514 1 2 1152015 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 0 1 1192001 74 MCG ( 74 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SYLATRON
Proper Name PEGINTERFERON ALFA-2B
March 2018 Page 30 of 42
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 5153 2 3292011 296 MCG ( 296 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 3 3292011 444 MCG ( 444 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 4 3292011 888 MCG ( 888 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name ZINPLAVA
Proper Name BEZLOTOXUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761046 0 1 10212016 1000 MG40 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No MERZ PHARMACEUTICALS GMBH 1830
Trade Name XEOMIN
Proper Name INCOBOTULINUMTOXINA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125360 0 1 7302010
POWDER INTRAMUSCULAR
50 U ( 50 UVIAL )
SINGLE-DOSE VIAL
125360 0 2 7302010
POWDER INTRAMUSCULAR
100 U ( 100 UVIAL )
SINGLE-DOSE VIAL
125360 3 3 11202015
POWDER INTRAMUSCULAR
200 U ( 200 UVIAL )
SINGLE-DOSE VIAL
March 2018 Page 31 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
Trade Name ARZERRA
Proper Name OFATUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125326 0 1 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG5 ML ( 20 MGML )
125326 0 2 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1000 MG50 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
125504 0
COSENTYX
SECUKINUMAB
Approval Date Product
1212015 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
150 MG ( 150 MGVIAL )
125504 0 2 1212015
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MGML ( 150 MGML )
125504 0 3 1212015
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MGML ( 150 MGML )
Trade Name
Proper Name
BLASTN
125290 0
EXTAVIA
INTERFERON BETA-1B
Approval Date Product
8142009 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
03 MG ( 03 MGVIAL )
Trade Name
Proper Name
BLASTN
125319 0
ILARIS
CANAKINUMAB
Approval Date Product
6172009 1
PotencyDosage FormRoutePresentation
180 MGVIAL ( 180 MGVIAL )
March 2018 Page 32 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
125319 88 2 12222016 150 MG ( 150 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
125319 0 3 12222016 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SIMULECT
Proper Name BASILIXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103764 0 1 5121998 10 MG ( 10 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
103764 0 2 5121998 20 MG ( 20 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No NPS PHARMACEUTICALS INC 1908
Trade Name NATPARA
Proper Name PARATHYROID HORMONE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 33 of 42
CDER Billable Biologic Product List
ApplicantLicense No PROMETHEUS LABORATORIES INC 1848
Trade Name PROLEUKIN
Proper Name ALDESLEUKIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103293 0 1 551992 22 MIU ( 22 MIUVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760
Trade Name ARCALYST
Proper Name RILONACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125249 0 1 2272008
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
220MG ( 220MGVIAL )
Trade Name
Proper Name
DUPIXENT
DUPILUMAB
BLASTN
761055 0
Product
1
Approval Date
3282017
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
300 MG2 ML ( 150 MGML )
Trade Name
Proper Name
EYLEA
AFLIBERCEPT
BLASTN
125387 0
Product
1
Approval Date
11182011
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
2 MG005 ML ( 40 MGML )
March 2018 Page 34 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Trade Name ELITEK
Proper Name RASBURICASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103946 0 1 7122002
POWDER INTRAVENOUS SINGLE-DOSE VIAL
15 MG ( 15 MGVIAL )
103946 5020 2 162006
POWDER INTRAVENOUS SINGLE-DOSE VIAL
75 MG ( 75 MGVIAL )
Trade Name
Proper Name
BLASTN
761037 0
KEVZARA
SARILUMAB
Approval Date Product
5222017 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MG114 ML ( 13158 MGML )
761037 0 2 5222017
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MG114 ML ( 17544 MGML )
761037 1 3 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MG114 ML ( 13158 MGML )
761037 1 4 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
200 MG114 ML ( 17544 MGML )
Trade Name
Proper Name
BLASTN
103362 0
LEUKINE
SARGRAMOSTIM
Approval Date Product
351991 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
250 MCG ( 250 MCGVIAL )
103362 0 2 351991
SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL
500 MCGML ( 500 MCGML )
Trade Name PRALUENT
March 2018 Page 35 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Proper Name ALIROCUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125559 0 1 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 2 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 3 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125559 0 4 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name ZALTRAP
Proper Name ZIV-AFLIBERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125418 0 1 832012 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125418 0 2 832012 200 MG8 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SEATTLE GENETICS INC 1853
Trade Name ADCETRIS
Proper Name BRENTUXIMAB VEDOTIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125388 1 1 8192011 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 36 of 42
CDER Billable Biologic Product List
ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593
Trade Name ELAPRASE
Proper Name IDURSULFASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125151 0 1 7242006 6 MG3 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SICOR BIOTECH UAB 1803
Trade Name GRANIX
Proper Name TBO-FILGRASTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125294 0 1 8292012
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
300 MCG0 5 ML ( 600 MCGML )
125294 0 2 8292012
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
480 MCG08 ML ( 600 MCGML )
ApplicantLicense No SMITH AND NEPHEW INC 2004
Trade Name REGRANEX
Proper Name BECAPLERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103691 0 1 12161997
GEL TOPICAL
100 UG ( 100 UGGM )
Trade Name
Proper Name
SANTYL
COLLAGENASE
BLASTN
101995 0
Product
1
Approval Date
641965
PotencyDosage FormRoutePresentation
OINTMENT TOPICAL
30 G amp 90 G TUBE ( 250 UGRAM )
March 2018 Page 37 of 42
CDER Billable Biologic Product List
ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718
Trade Name MYOBLOC
Proper Name RIMABOTULINUM TOXIN B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103846 0 1 1282002
SOLUTION INTRAMUSCULAR
2500 IU05 ML ( 5000 IUML )
SINGLE-DOSE VIAL
103846 0 3 1282002
SOLUTION INTRAMUSCULAR
10000 IU2 ML ( 5000 IUML )
SINGLE-DOSE VIAL
Proper Name RIMABOTULINUMTOXINB
BLASTN
103846 0
Product
2
Approval Date
1282002
PotencyDosage FormRoutePresentation
SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL
5000 IUML ( 5000 IUML )
ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832
Trade Name ZEVALIN
Proper Name IBRITUMOMAB TIUXETAN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125019 0 1 2192002 32 MG2 ML ( 16 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
Trade Name KEPIVANCE
Proper Name PALIFERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125103 0 1 12152004 625 MG ( 625 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name KINERET
Proper Name ANAKINRA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 38 of 42
CDER Billable Biologic Product List
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898
Trade Name ENTYVIO
Proper Name VEDOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125476 0 1 5202014 300 MG ( 300 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No TEVA RESPIRATORY LLC 2047
Trade Name CINQAIR
Proper Name RESLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761033 0 1 3232016 100 MG10 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No THERATECHNOLOGIES INC 2091
Trade Name TROGARZO
Proper Name IBALIZUMAB-UIYK
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761065 0 1 362018 200 MG133 ML ( 150 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 39 of 42
CDER Billable Biologic Product List
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
0375 MG03 ML ( 125 MGML )2222017 125422 038 1
ApplicantLicense No UCB INC 1736
Trade Name CIMZIA
Proper Name CERTOLIZUMAB PEGOL
BLASTN Approval Date PotencyDosage FormRoutePresentation Product
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
200 MG ( 200 MGVIAL ) 4222008 125160 0 1
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )5132009 125160 080 2
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
Trade Name CRYSVITA
Proper Name BUROSUMAB-TWZA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761068 0 1 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
10 MGML ( 10 MGML )
761068 0 2 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
20 MGML ( 20 MGML )
761068 0
Trade Name
Proper Name
BLASTN
March 2018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML ) 4172018 3
MEPSEVII
VESTRONIDASE ALFA-VJBK
Approval Date PotencyDosage FormRoutePresentation Product
Page 40 of 42
CDER Billable Biologic Product List
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
761047 0 1 11152017 10 MG5 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No UNITED THERAPEUTICS CORP 1993
Trade Name UNITUXIN
Proper Name DINUTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125516 0 1 3102015 175 MG5 ML ( 35 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053
Trade Name SILIQ
Proper Name BRODALUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761032 0 1 2152017 210 MG15 ML ( 140 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 41 of 42
CDER Billable Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No WYETH PHARMACEUTICALS INC 0003
Trade Name BESPONSA
Proper Name INOTUZUMAB OZOGAMICIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761040 0 1 8172017 09 MG ( 09 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 42 of 42
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 1 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
9172001 103951 0 26
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
200 MCGML ( 200 MCGML ) 09272012
103951 0 27 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
200 MCG04 ML ( 500 MCGML ) 09272012
103951 0 28 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
300 MCGML ( 300 MCGML ) 09272012
103951 0 29 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
300 MCG06 ML ( 500 MCGML ) 09272012
103951 0 30 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
500 MCGML ( 500 MCGML ) 09272012
ApplicantLicense No ASTELLAS PHARMACEUTICALS US INC 1748
Trade Name AMEVIVE
Proper Name ALEFACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125036 0 1 1302003 75 MGVIAL ( 75 MGVIAL ) 09242008
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
125036 0 2 1302003 15 MGVIAL ( 15 MGVIAL ) 09282012
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No BOEHRINGER INGELHEIM PHARMA KG 1251
Trade Name VERLUMA
Proper Name NOFETUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103769 0 1 10131998 10 MGML ( 10 MGML ) 08132013
INTRAVENOUS
March 2018 Page 2 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No CENTOCOR ORTHO BIOTECH PRODUCTS LP 1824
Trade Name ORTHOCLONE OKT3
Proper Name MUROMONAB-CD3
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103463 0 1 9141992 1 MGML ( 1 MGML ) 01112012
SOLUTION INTRAVENOUS AMPULE
ApplicantLicense No EISAI INCORPORATED 1862
Trade Name ONTAK
Proper Name DENILEUKIN DIFTITOX
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103767 0 1 251999 300 MCG2 ML ( 150 MCGML ) 01302014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No ELI LILLY AND CO 1611
Trade Name XIGRIS
Proper Name DROTRECOGIN ALFA (ACTIVATED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125029 0 1 11212001 5 MGVIAL ( 5 MGVIAL ) 10262011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125029 0 2 11212001 20 MGVIAL ( 20 MGVIAL ) 10102011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GENENTECH INC 1048
Trade Name RAPTIVA
Proper Name EFALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125075 0 1 10272003 125 MGVIAL ( 125 MGVIAL ) 09012009
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
March 2018 Page 3 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103976 0 2 6202003 125 MGVIAL ( 125 MGVIAL ) 08252016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103948 0 3 572001 10 MGVIAL ( 10 MGVIAL ) 07062011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name MYOZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125141 0 1 4282006 50 MGVIAL ( 50 MGVIAL ) 10172014
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name BEXXAR THERAPEUTIC REGIME
Proper Name TOSITUMOMAB AND IODINE I-131 TOSITUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125011 0 1 6272003 01 MGML I-131 TOSITUMOMAB ( 01 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 2 6272003 11 MGML I-131 TOSITUMOMAB ( 11 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 3 6272003 14 MGML TOSITUMOMAB ( 14 MGML 03102014 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 4 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No HEMISPHERX BIOPHARMA INC 1703
Trade Name ALFERON N INJECTION
Proper Name INTERFERON ALFA-N3 (HUMAN LEUKOCYTE DERIVED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103158 0 1 10101989 5 MIUVIAL ( 5 MIUVIAL ) 06272013
SOLUTION INTRALESIONAL MULTI-DOSE VIAL
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name ROFERON A
Proper Name INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103145 0 1 641986 3 MIU05 ML ( 3 MIU05 ML ) 06012009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name ZENAPAX
Proper Name DACLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103749 0 1 12101997 25 MG5 ML ( 25 MG5 ML ) 07072011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No KADMON PHARMACEUTICALS LLC 1867
Trade Name INFERGEN
Proper Name INTERFERON ALFACON-1
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103663 0 1 1061997 9 MCG03 ML ( 30 MCGML ) 07252013
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 5 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103770 0 3 6191998 50 MGVIAL ( 50 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
103770 0 4 6191998 100 MGVIAL ( 100 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name INTRON A
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103132 0 6 641986 10 MIUML ( 10 MIUML ) 09232013
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103132 0 7 641986 225 MIU15 ML ( 225 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 8 641986 375 MIU15 ML ( 375 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 9 641986 75 MIU15 ML ( 75 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103949 0 5 1192001 675 MCGPEN ( 675 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 6 1192001 108 MCGPEN ( 108 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
March 2018 Page 6 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name PEGINTRON
103949 0 7 1192001 1184 MCGVIAL ( 1184 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 8 1192001 162 MCGPEN ( 162 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 9 1192001 1776 MCGVIAL ( 1776 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 10 1192001 2025 MCGPEN ( 2025 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 11 1192001 222 MCGVIAL ( 222 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No PALATIN TECHNOLOGIES INC 1588
Trade Name NEUTROSPEC TECHNETIUM (99M TC)
Proper Name FANOLESOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103928 0 1 722004 025 MGVIAL ( 025 MGVIAL ) 09222008
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No RECORDATI RARE DISEASES INC 1899
Trade Name ELSPAR
Proper Name ASPARAGINASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
101063 0 1 1101978 10000 IU ( 10000 IUVIAL ) 04092014
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
March 2018 Page 7 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No SCHERING CORP 0994
Trade Name PEGINTRONREBETOL COMBO PACK
Proper Name PEGINTERFERON ALFA-2B AND RIBAVIRIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125196 0 1 6132008 ( 4 (120 MCG05ML) REDIPEN amp 140 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 2 6132008 ( 4 (150 MCG05ML) REDIPEN amp 168 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 3 6132008 ( 4 (150 MCG05ML) REDIPEN amp 196 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 4 6132008 ( 4 (50 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 5 6132008 ( 4 (80 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125422 0 2 10172012 05 MG ( 25 MGML ) 08082017
SOLUTION INTRAVETREAL SINGLE-DOSE VIAL
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125164 0 10 11142007 50 MCGML ( 50 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 8 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
125164 0 11 11142007 100 MCGML ( 100 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 12 11142007 200 MCGML ( 200 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 13 11142007 300 MCGML ( 300 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 14 11142007 400 MCGML ( 400 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 15 11142007 400 MCG06 ML ( 400 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 16 11142007 600 MCGML ( 600 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 17 11142007 600 MCG06 ML ( 600 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 18 11142007 800 MCG06 ML ( 800 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 19 11142007 1000 MCGML ( 1000 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 9 of 9
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
125289 0 4 4242009 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name SIMPONI ARIA
Proper Name GOLIMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125433 0 1 7182013 50 MG4 ML ( 125 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name STELARA
Proper Name USTEKINUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125261 0 1 9252009 90 MGML ( 90 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125261 0 2 9252009 45 MG05 ML ( 90 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL amp PREFILLED SYRINGE
125261 0 3 9252009 130 MG26 ML ( 5 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761044 0 1 9232016 130 MG26 ML ( 5 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SYLVANT
Proper Name SILTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125496 0 1 4232014 100 MG ( 100 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125496 0 2 4232014 400 MG ( 400 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 28 of 42
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
Trade Name TREMFYA
Proper Name GUSELKUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761061 0 1 7132017 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No JAZZ PHARMACEUTICALS INC 1901
Trade Name ERWINAZE
Proper Name ASPARAGINASE ERWINIA CHRYSANTHEMI
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
105359 0 1 11182011 10000 IU ( 10000 IUVIAL )
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103770 0 1 6191998
SOLUTION INTRAMUSCULAR
50 MG05 ML ( 100 MGML )
SINGLE-DOSE VIAL
103770 0 2 6191998
SOLUTION INTRAMUSCULAR
100 MGML ( 100 MGML )
SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name ILUMYA
Proper Name TILDRAKIZUMAB-ASMN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761067 0 1 3202018 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name INTRON A
March 2018 Page 29 of 42
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103132 0 1 641986 10 MIU ( 10 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL INTRAVENOUS SINGLE-DOSE VIAL
103132 0 2 641986 18 MIU ( 18 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL
103132 0 3 641986 50 MIU ( 50 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL
103132 0 4 641986 228 MIU38 ML ( 6 MIUML )
SOLUTION INTRAMUSCULAR SUBCUTANEOUS MULTI-DOSE VIAL
103132 0 5 641986 32 MIU32 ML ( 10 MIUML )
SOLUTION INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL MULTI-DOSE VIAL
Trade Name KEYTRUDA
Proper Name PEMBROLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125514 0 1 942014 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125514 1 2 1152015 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 0 1 1192001 74 MCG ( 74 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SYLATRON
Proper Name PEGINTERFERON ALFA-2B
March 2018 Page 30 of 42
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 5153 2 3292011 296 MCG ( 296 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 3 3292011 444 MCG ( 444 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 4 3292011 888 MCG ( 888 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name ZINPLAVA
Proper Name BEZLOTOXUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761046 0 1 10212016 1000 MG40 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No MERZ PHARMACEUTICALS GMBH 1830
Trade Name XEOMIN
Proper Name INCOBOTULINUMTOXINA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125360 0 1 7302010
POWDER INTRAMUSCULAR
50 U ( 50 UVIAL )
SINGLE-DOSE VIAL
125360 0 2 7302010
POWDER INTRAMUSCULAR
100 U ( 100 UVIAL )
SINGLE-DOSE VIAL
125360 3 3 11202015
POWDER INTRAMUSCULAR
200 U ( 200 UVIAL )
SINGLE-DOSE VIAL
March 2018 Page 31 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
Trade Name ARZERRA
Proper Name OFATUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125326 0 1 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG5 ML ( 20 MGML )
125326 0 2 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1000 MG50 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
125504 0
COSENTYX
SECUKINUMAB
Approval Date Product
1212015 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
150 MG ( 150 MGVIAL )
125504 0 2 1212015
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MGML ( 150 MGML )
125504 0 3 1212015
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MGML ( 150 MGML )
Trade Name
Proper Name
BLASTN
125290 0
EXTAVIA
INTERFERON BETA-1B
Approval Date Product
8142009 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
03 MG ( 03 MGVIAL )
Trade Name
Proper Name
BLASTN
125319 0
ILARIS
CANAKINUMAB
Approval Date Product
6172009 1
PotencyDosage FormRoutePresentation
180 MGVIAL ( 180 MGVIAL )
March 2018 Page 32 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
125319 88 2 12222016 150 MG ( 150 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
125319 0 3 12222016 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SIMULECT
Proper Name BASILIXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103764 0 1 5121998 10 MG ( 10 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
103764 0 2 5121998 20 MG ( 20 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No NPS PHARMACEUTICALS INC 1908
Trade Name NATPARA
Proper Name PARATHYROID HORMONE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 33 of 42
CDER Billable Biologic Product List
ApplicantLicense No PROMETHEUS LABORATORIES INC 1848
Trade Name PROLEUKIN
Proper Name ALDESLEUKIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103293 0 1 551992 22 MIU ( 22 MIUVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760
Trade Name ARCALYST
Proper Name RILONACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125249 0 1 2272008
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
220MG ( 220MGVIAL )
Trade Name
Proper Name
DUPIXENT
DUPILUMAB
BLASTN
761055 0
Product
1
Approval Date
3282017
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
300 MG2 ML ( 150 MGML )
Trade Name
Proper Name
EYLEA
AFLIBERCEPT
BLASTN
125387 0
Product
1
Approval Date
11182011
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
2 MG005 ML ( 40 MGML )
March 2018 Page 34 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Trade Name ELITEK
Proper Name RASBURICASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103946 0 1 7122002
POWDER INTRAVENOUS SINGLE-DOSE VIAL
15 MG ( 15 MGVIAL )
103946 5020 2 162006
POWDER INTRAVENOUS SINGLE-DOSE VIAL
75 MG ( 75 MGVIAL )
Trade Name
Proper Name
BLASTN
761037 0
KEVZARA
SARILUMAB
Approval Date Product
5222017 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MG114 ML ( 13158 MGML )
761037 0 2 5222017
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MG114 ML ( 17544 MGML )
761037 1 3 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MG114 ML ( 13158 MGML )
761037 1 4 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
200 MG114 ML ( 17544 MGML )
Trade Name
Proper Name
BLASTN
103362 0
LEUKINE
SARGRAMOSTIM
Approval Date Product
351991 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
250 MCG ( 250 MCGVIAL )
103362 0 2 351991
SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL
500 MCGML ( 500 MCGML )
Trade Name PRALUENT
March 2018 Page 35 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Proper Name ALIROCUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125559 0 1 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 2 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 3 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125559 0 4 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name ZALTRAP
Proper Name ZIV-AFLIBERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125418 0 1 832012 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125418 0 2 832012 200 MG8 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SEATTLE GENETICS INC 1853
Trade Name ADCETRIS
Proper Name BRENTUXIMAB VEDOTIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125388 1 1 8192011 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 36 of 42
CDER Billable Biologic Product List
ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593
Trade Name ELAPRASE
Proper Name IDURSULFASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125151 0 1 7242006 6 MG3 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SICOR BIOTECH UAB 1803
Trade Name GRANIX
Proper Name TBO-FILGRASTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125294 0 1 8292012
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
300 MCG0 5 ML ( 600 MCGML )
125294 0 2 8292012
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
480 MCG08 ML ( 600 MCGML )
ApplicantLicense No SMITH AND NEPHEW INC 2004
Trade Name REGRANEX
Proper Name BECAPLERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103691 0 1 12161997
GEL TOPICAL
100 UG ( 100 UGGM )
Trade Name
Proper Name
SANTYL
COLLAGENASE
BLASTN
101995 0
Product
1
Approval Date
641965
PotencyDosage FormRoutePresentation
OINTMENT TOPICAL
30 G amp 90 G TUBE ( 250 UGRAM )
March 2018 Page 37 of 42
CDER Billable Biologic Product List
ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718
Trade Name MYOBLOC
Proper Name RIMABOTULINUM TOXIN B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103846 0 1 1282002
SOLUTION INTRAMUSCULAR
2500 IU05 ML ( 5000 IUML )
SINGLE-DOSE VIAL
103846 0 3 1282002
SOLUTION INTRAMUSCULAR
10000 IU2 ML ( 5000 IUML )
SINGLE-DOSE VIAL
Proper Name RIMABOTULINUMTOXINB
BLASTN
103846 0
Product
2
Approval Date
1282002
PotencyDosage FormRoutePresentation
SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL
5000 IUML ( 5000 IUML )
ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832
Trade Name ZEVALIN
Proper Name IBRITUMOMAB TIUXETAN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125019 0 1 2192002 32 MG2 ML ( 16 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
Trade Name KEPIVANCE
Proper Name PALIFERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125103 0 1 12152004 625 MG ( 625 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name KINERET
Proper Name ANAKINRA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 38 of 42
CDER Billable Biologic Product List
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898
Trade Name ENTYVIO
Proper Name VEDOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125476 0 1 5202014 300 MG ( 300 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No TEVA RESPIRATORY LLC 2047
Trade Name CINQAIR
Proper Name RESLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761033 0 1 3232016 100 MG10 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No THERATECHNOLOGIES INC 2091
Trade Name TROGARZO
Proper Name IBALIZUMAB-UIYK
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761065 0 1 362018 200 MG133 ML ( 150 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 39 of 42
CDER Billable Biologic Product List
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
0375 MG03 ML ( 125 MGML )2222017 125422 038 1
ApplicantLicense No UCB INC 1736
Trade Name CIMZIA
Proper Name CERTOLIZUMAB PEGOL
BLASTN Approval Date PotencyDosage FormRoutePresentation Product
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
200 MG ( 200 MGVIAL ) 4222008 125160 0 1
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )5132009 125160 080 2
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
Trade Name CRYSVITA
Proper Name BUROSUMAB-TWZA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761068 0 1 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
10 MGML ( 10 MGML )
761068 0 2 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
20 MGML ( 20 MGML )
761068 0
Trade Name
Proper Name
BLASTN
March 2018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML ) 4172018 3
MEPSEVII
VESTRONIDASE ALFA-VJBK
Approval Date PotencyDosage FormRoutePresentation Product
Page 40 of 42
CDER Billable Biologic Product List
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
761047 0 1 11152017 10 MG5 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No UNITED THERAPEUTICS CORP 1993
Trade Name UNITUXIN
Proper Name DINUTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125516 0 1 3102015 175 MG5 ML ( 35 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053
Trade Name SILIQ
Proper Name BRODALUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761032 0 1 2152017 210 MG15 ML ( 140 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 41 of 42
CDER Billable Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No WYETH PHARMACEUTICALS INC 0003
Trade Name BESPONSA
Proper Name INOTUZUMAB OZOGAMICIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761040 0 1 8172017 09 MG ( 09 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 42 of 42
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 1 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
9172001 103951 0 26
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
200 MCGML ( 200 MCGML ) 09272012
103951 0 27 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
200 MCG04 ML ( 500 MCGML ) 09272012
103951 0 28 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
300 MCGML ( 300 MCGML ) 09272012
103951 0 29 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
300 MCG06 ML ( 500 MCGML ) 09272012
103951 0 30 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
500 MCGML ( 500 MCGML ) 09272012
ApplicantLicense No ASTELLAS PHARMACEUTICALS US INC 1748
Trade Name AMEVIVE
Proper Name ALEFACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125036 0 1 1302003 75 MGVIAL ( 75 MGVIAL ) 09242008
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
125036 0 2 1302003 15 MGVIAL ( 15 MGVIAL ) 09282012
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No BOEHRINGER INGELHEIM PHARMA KG 1251
Trade Name VERLUMA
Proper Name NOFETUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103769 0 1 10131998 10 MGML ( 10 MGML ) 08132013
INTRAVENOUS
March 2018 Page 2 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No CENTOCOR ORTHO BIOTECH PRODUCTS LP 1824
Trade Name ORTHOCLONE OKT3
Proper Name MUROMONAB-CD3
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103463 0 1 9141992 1 MGML ( 1 MGML ) 01112012
SOLUTION INTRAVENOUS AMPULE
ApplicantLicense No EISAI INCORPORATED 1862
Trade Name ONTAK
Proper Name DENILEUKIN DIFTITOX
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103767 0 1 251999 300 MCG2 ML ( 150 MCGML ) 01302014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No ELI LILLY AND CO 1611
Trade Name XIGRIS
Proper Name DROTRECOGIN ALFA (ACTIVATED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125029 0 1 11212001 5 MGVIAL ( 5 MGVIAL ) 10262011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125029 0 2 11212001 20 MGVIAL ( 20 MGVIAL ) 10102011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GENENTECH INC 1048
Trade Name RAPTIVA
Proper Name EFALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125075 0 1 10272003 125 MGVIAL ( 125 MGVIAL ) 09012009
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
March 2018 Page 3 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103976 0 2 6202003 125 MGVIAL ( 125 MGVIAL ) 08252016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103948 0 3 572001 10 MGVIAL ( 10 MGVIAL ) 07062011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name MYOZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125141 0 1 4282006 50 MGVIAL ( 50 MGVIAL ) 10172014
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name BEXXAR THERAPEUTIC REGIME
Proper Name TOSITUMOMAB AND IODINE I-131 TOSITUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125011 0 1 6272003 01 MGML I-131 TOSITUMOMAB ( 01 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 2 6272003 11 MGML I-131 TOSITUMOMAB ( 11 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 3 6272003 14 MGML TOSITUMOMAB ( 14 MGML 03102014 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 4 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No HEMISPHERX BIOPHARMA INC 1703
Trade Name ALFERON N INJECTION
Proper Name INTERFERON ALFA-N3 (HUMAN LEUKOCYTE DERIVED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103158 0 1 10101989 5 MIUVIAL ( 5 MIUVIAL ) 06272013
SOLUTION INTRALESIONAL MULTI-DOSE VIAL
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name ROFERON A
Proper Name INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103145 0 1 641986 3 MIU05 ML ( 3 MIU05 ML ) 06012009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name ZENAPAX
Proper Name DACLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103749 0 1 12101997 25 MG5 ML ( 25 MG5 ML ) 07072011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No KADMON PHARMACEUTICALS LLC 1867
Trade Name INFERGEN
Proper Name INTERFERON ALFACON-1
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103663 0 1 1061997 9 MCG03 ML ( 30 MCGML ) 07252013
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 5 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103770 0 3 6191998 50 MGVIAL ( 50 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
103770 0 4 6191998 100 MGVIAL ( 100 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name INTRON A
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103132 0 6 641986 10 MIUML ( 10 MIUML ) 09232013
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103132 0 7 641986 225 MIU15 ML ( 225 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 8 641986 375 MIU15 ML ( 375 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 9 641986 75 MIU15 ML ( 75 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103949 0 5 1192001 675 MCGPEN ( 675 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 6 1192001 108 MCGPEN ( 108 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
March 2018 Page 6 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name PEGINTRON
103949 0 7 1192001 1184 MCGVIAL ( 1184 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 8 1192001 162 MCGPEN ( 162 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 9 1192001 1776 MCGVIAL ( 1776 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 10 1192001 2025 MCGPEN ( 2025 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 11 1192001 222 MCGVIAL ( 222 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No PALATIN TECHNOLOGIES INC 1588
Trade Name NEUTROSPEC TECHNETIUM (99M TC)
Proper Name FANOLESOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103928 0 1 722004 025 MGVIAL ( 025 MGVIAL ) 09222008
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No RECORDATI RARE DISEASES INC 1899
Trade Name ELSPAR
Proper Name ASPARAGINASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
101063 0 1 1101978 10000 IU ( 10000 IUVIAL ) 04092014
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
March 2018 Page 7 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No SCHERING CORP 0994
Trade Name PEGINTRONREBETOL COMBO PACK
Proper Name PEGINTERFERON ALFA-2B AND RIBAVIRIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125196 0 1 6132008 ( 4 (120 MCG05ML) REDIPEN amp 140 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 2 6132008 ( 4 (150 MCG05ML) REDIPEN amp 168 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 3 6132008 ( 4 (150 MCG05ML) REDIPEN amp 196 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 4 6132008 ( 4 (50 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 5 6132008 ( 4 (80 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125422 0 2 10172012 05 MG ( 25 MGML ) 08082017
SOLUTION INTRAVETREAL SINGLE-DOSE VIAL
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125164 0 10 11142007 50 MCGML ( 50 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 8 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
125164 0 11 11142007 100 MCGML ( 100 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 12 11142007 200 MCGML ( 200 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 13 11142007 300 MCGML ( 300 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 14 11142007 400 MCGML ( 400 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 15 11142007 400 MCG06 ML ( 400 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 16 11142007 600 MCGML ( 600 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 17 11142007 600 MCG06 ML ( 600 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 18 11142007 800 MCG06 ML ( 800 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 19 11142007 1000 MCGML ( 1000 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 9 of 9
CDER Billable Biologic Product List
ApplicantLicense No JANSSEN BIOTECH INC 1864
Trade Name TREMFYA
Proper Name GUSELKUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761061 0 1 7132017 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No JAZZ PHARMACEUTICALS INC 1901
Trade Name ERWINAZE
Proper Name ASPARAGINASE ERWINIA CHRYSANTHEMI
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
105359 0 1 11182011 10000 IU ( 10000 IUVIAL )
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103770 0 1 6191998
SOLUTION INTRAMUSCULAR
50 MG05 ML ( 100 MGML )
SINGLE-DOSE VIAL
103770 0 2 6191998
SOLUTION INTRAMUSCULAR
100 MGML ( 100 MGML )
SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name ILUMYA
Proper Name TILDRAKIZUMAB-ASMN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761067 0 1 3202018 100 MGML ( 100 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name INTRON A
March 2018 Page 29 of 42
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103132 0 1 641986 10 MIU ( 10 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL INTRAVENOUS SINGLE-DOSE VIAL
103132 0 2 641986 18 MIU ( 18 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL
103132 0 3 641986 50 MIU ( 50 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL
103132 0 4 641986 228 MIU38 ML ( 6 MIUML )
SOLUTION INTRAMUSCULAR SUBCUTANEOUS MULTI-DOSE VIAL
103132 0 5 641986 32 MIU32 ML ( 10 MIUML )
SOLUTION INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL MULTI-DOSE VIAL
Trade Name KEYTRUDA
Proper Name PEMBROLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125514 0 1 942014 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125514 1 2 1152015 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 0 1 1192001 74 MCG ( 74 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SYLATRON
Proper Name PEGINTERFERON ALFA-2B
March 2018 Page 30 of 42
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 5153 2 3292011 296 MCG ( 296 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 3 3292011 444 MCG ( 444 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 4 3292011 888 MCG ( 888 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name ZINPLAVA
Proper Name BEZLOTOXUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761046 0 1 10212016 1000 MG40 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No MERZ PHARMACEUTICALS GMBH 1830
Trade Name XEOMIN
Proper Name INCOBOTULINUMTOXINA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125360 0 1 7302010
POWDER INTRAMUSCULAR
50 U ( 50 UVIAL )
SINGLE-DOSE VIAL
125360 0 2 7302010
POWDER INTRAMUSCULAR
100 U ( 100 UVIAL )
SINGLE-DOSE VIAL
125360 3 3 11202015
POWDER INTRAMUSCULAR
200 U ( 200 UVIAL )
SINGLE-DOSE VIAL
March 2018 Page 31 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
Trade Name ARZERRA
Proper Name OFATUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125326 0 1 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG5 ML ( 20 MGML )
125326 0 2 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1000 MG50 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
125504 0
COSENTYX
SECUKINUMAB
Approval Date Product
1212015 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
150 MG ( 150 MGVIAL )
125504 0 2 1212015
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MGML ( 150 MGML )
125504 0 3 1212015
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MGML ( 150 MGML )
Trade Name
Proper Name
BLASTN
125290 0
EXTAVIA
INTERFERON BETA-1B
Approval Date Product
8142009 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
03 MG ( 03 MGVIAL )
Trade Name
Proper Name
BLASTN
125319 0
ILARIS
CANAKINUMAB
Approval Date Product
6172009 1
PotencyDosage FormRoutePresentation
180 MGVIAL ( 180 MGVIAL )
March 2018 Page 32 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
125319 88 2 12222016 150 MG ( 150 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
125319 0 3 12222016 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SIMULECT
Proper Name BASILIXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103764 0 1 5121998 10 MG ( 10 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
103764 0 2 5121998 20 MG ( 20 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No NPS PHARMACEUTICALS INC 1908
Trade Name NATPARA
Proper Name PARATHYROID HORMONE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 33 of 42
CDER Billable Biologic Product List
ApplicantLicense No PROMETHEUS LABORATORIES INC 1848
Trade Name PROLEUKIN
Proper Name ALDESLEUKIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103293 0 1 551992 22 MIU ( 22 MIUVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760
Trade Name ARCALYST
Proper Name RILONACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125249 0 1 2272008
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
220MG ( 220MGVIAL )
Trade Name
Proper Name
DUPIXENT
DUPILUMAB
BLASTN
761055 0
Product
1
Approval Date
3282017
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
300 MG2 ML ( 150 MGML )
Trade Name
Proper Name
EYLEA
AFLIBERCEPT
BLASTN
125387 0
Product
1
Approval Date
11182011
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
2 MG005 ML ( 40 MGML )
March 2018 Page 34 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Trade Name ELITEK
Proper Name RASBURICASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103946 0 1 7122002
POWDER INTRAVENOUS SINGLE-DOSE VIAL
15 MG ( 15 MGVIAL )
103946 5020 2 162006
POWDER INTRAVENOUS SINGLE-DOSE VIAL
75 MG ( 75 MGVIAL )
Trade Name
Proper Name
BLASTN
761037 0
KEVZARA
SARILUMAB
Approval Date Product
5222017 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MG114 ML ( 13158 MGML )
761037 0 2 5222017
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MG114 ML ( 17544 MGML )
761037 1 3 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MG114 ML ( 13158 MGML )
761037 1 4 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
200 MG114 ML ( 17544 MGML )
Trade Name
Proper Name
BLASTN
103362 0
LEUKINE
SARGRAMOSTIM
Approval Date Product
351991 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
250 MCG ( 250 MCGVIAL )
103362 0 2 351991
SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL
500 MCGML ( 500 MCGML )
Trade Name PRALUENT
March 2018 Page 35 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Proper Name ALIROCUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125559 0 1 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 2 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 3 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125559 0 4 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name ZALTRAP
Proper Name ZIV-AFLIBERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125418 0 1 832012 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125418 0 2 832012 200 MG8 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SEATTLE GENETICS INC 1853
Trade Name ADCETRIS
Proper Name BRENTUXIMAB VEDOTIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125388 1 1 8192011 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 36 of 42
CDER Billable Biologic Product List
ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593
Trade Name ELAPRASE
Proper Name IDURSULFASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125151 0 1 7242006 6 MG3 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SICOR BIOTECH UAB 1803
Trade Name GRANIX
Proper Name TBO-FILGRASTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125294 0 1 8292012
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
300 MCG0 5 ML ( 600 MCGML )
125294 0 2 8292012
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
480 MCG08 ML ( 600 MCGML )
ApplicantLicense No SMITH AND NEPHEW INC 2004
Trade Name REGRANEX
Proper Name BECAPLERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103691 0 1 12161997
GEL TOPICAL
100 UG ( 100 UGGM )
Trade Name
Proper Name
SANTYL
COLLAGENASE
BLASTN
101995 0
Product
1
Approval Date
641965
PotencyDosage FormRoutePresentation
OINTMENT TOPICAL
30 G amp 90 G TUBE ( 250 UGRAM )
March 2018 Page 37 of 42
CDER Billable Biologic Product List
ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718
Trade Name MYOBLOC
Proper Name RIMABOTULINUM TOXIN B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103846 0 1 1282002
SOLUTION INTRAMUSCULAR
2500 IU05 ML ( 5000 IUML )
SINGLE-DOSE VIAL
103846 0 3 1282002
SOLUTION INTRAMUSCULAR
10000 IU2 ML ( 5000 IUML )
SINGLE-DOSE VIAL
Proper Name RIMABOTULINUMTOXINB
BLASTN
103846 0
Product
2
Approval Date
1282002
PotencyDosage FormRoutePresentation
SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL
5000 IUML ( 5000 IUML )
ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832
Trade Name ZEVALIN
Proper Name IBRITUMOMAB TIUXETAN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125019 0 1 2192002 32 MG2 ML ( 16 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
Trade Name KEPIVANCE
Proper Name PALIFERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125103 0 1 12152004 625 MG ( 625 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name KINERET
Proper Name ANAKINRA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 38 of 42
CDER Billable Biologic Product List
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898
Trade Name ENTYVIO
Proper Name VEDOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125476 0 1 5202014 300 MG ( 300 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No TEVA RESPIRATORY LLC 2047
Trade Name CINQAIR
Proper Name RESLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761033 0 1 3232016 100 MG10 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No THERATECHNOLOGIES INC 2091
Trade Name TROGARZO
Proper Name IBALIZUMAB-UIYK
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761065 0 1 362018 200 MG133 ML ( 150 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 39 of 42
CDER Billable Biologic Product List
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
0375 MG03 ML ( 125 MGML )2222017 125422 038 1
ApplicantLicense No UCB INC 1736
Trade Name CIMZIA
Proper Name CERTOLIZUMAB PEGOL
BLASTN Approval Date PotencyDosage FormRoutePresentation Product
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
200 MG ( 200 MGVIAL ) 4222008 125160 0 1
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )5132009 125160 080 2
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
Trade Name CRYSVITA
Proper Name BUROSUMAB-TWZA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761068 0 1 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
10 MGML ( 10 MGML )
761068 0 2 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
20 MGML ( 20 MGML )
761068 0
Trade Name
Proper Name
BLASTN
March 2018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML ) 4172018 3
MEPSEVII
VESTRONIDASE ALFA-VJBK
Approval Date PotencyDosage FormRoutePresentation Product
Page 40 of 42
CDER Billable Biologic Product List
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
761047 0 1 11152017 10 MG5 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No UNITED THERAPEUTICS CORP 1993
Trade Name UNITUXIN
Proper Name DINUTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125516 0 1 3102015 175 MG5 ML ( 35 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053
Trade Name SILIQ
Proper Name BRODALUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761032 0 1 2152017 210 MG15 ML ( 140 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 41 of 42
CDER Billable Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No WYETH PHARMACEUTICALS INC 0003
Trade Name BESPONSA
Proper Name INOTUZUMAB OZOGAMICIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761040 0 1 8172017 09 MG ( 09 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 42 of 42
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 1 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
9172001 103951 0 26
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
200 MCGML ( 200 MCGML ) 09272012
103951 0 27 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
200 MCG04 ML ( 500 MCGML ) 09272012
103951 0 28 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
300 MCGML ( 300 MCGML ) 09272012
103951 0 29 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
300 MCG06 ML ( 500 MCGML ) 09272012
103951 0 30 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
500 MCGML ( 500 MCGML ) 09272012
ApplicantLicense No ASTELLAS PHARMACEUTICALS US INC 1748
Trade Name AMEVIVE
Proper Name ALEFACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125036 0 1 1302003 75 MGVIAL ( 75 MGVIAL ) 09242008
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
125036 0 2 1302003 15 MGVIAL ( 15 MGVIAL ) 09282012
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No BOEHRINGER INGELHEIM PHARMA KG 1251
Trade Name VERLUMA
Proper Name NOFETUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103769 0 1 10131998 10 MGML ( 10 MGML ) 08132013
INTRAVENOUS
March 2018 Page 2 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No CENTOCOR ORTHO BIOTECH PRODUCTS LP 1824
Trade Name ORTHOCLONE OKT3
Proper Name MUROMONAB-CD3
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103463 0 1 9141992 1 MGML ( 1 MGML ) 01112012
SOLUTION INTRAVENOUS AMPULE
ApplicantLicense No EISAI INCORPORATED 1862
Trade Name ONTAK
Proper Name DENILEUKIN DIFTITOX
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103767 0 1 251999 300 MCG2 ML ( 150 MCGML ) 01302014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No ELI LILLY AND CO 1611
Trade Name XIGRIS
Proper Name DROTRECOGIN ALFA (ACTIVATED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125029 0 1 11212001 5 MGVIAL ( 5 MGVIAL ) 10262011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125029 0 2 11212001 20 MGVIAL ( 20 MGVIAL ) 10102011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GENENTECH INC 1048
Trade Name RAPTIVA
Proper Name EFALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125075 0 1 10272003 125 MGVIAL ( 125 MGVIAL ) 09012009
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
March 2018 Page 3 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103976 0 2 6202003 125 MGVIAL ( 125 MGVIAL ) 08252016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103948 0 3 572001 10 MGVIAL ( 10 MGVIAL ) 07062011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name MYOZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125141 0 1 4282006 50 MGVIAL ( 50 MGVIAL ) 10172014
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name BEXXAR THERAPEUTIC REGIME
Proper Name TOSITUMOMAB AND IODINE I-131 TOSITUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125011 0 1 6272003 01 MGML I-131 TOSITUMOMAB ( 01 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 2 6272003 11 MGML I-131 TOSITUMOMAB ( 11 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 3 6272003 14 MGML TOSITUMOMAB ( 14 MGML 03102014 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 4 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No HEMISPHERX BIOPHARMA INC 1703
Trade Name ALFERON N INJECTION
Proper Name INTERFERON ALFA-N3 (HUMAN LEUKOCYTE DERIVED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103158 0 1 10101989 5 MIUVIAL ( 5 MIUVIAL ) 06272013
SOLUTION INTRALESIONAL MULTI-DOSE VIAL
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name ROFERON A
Proper Name INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103145 0 1 641986 3 MIU05 ML ( 3 MIU05 ML ) 06012009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name ZENAPAX
Proper Name DACLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103749 0 1 12101997 25 MG5 ML ( 25 MG5 ML ) 07072011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No KADMON PHARMACEUTICALS LLC 1867
Trade Name INFERGEN
Proper Name INTERFERON ALFACON-1
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103663 0 1 1061997 9 MCG03 ML ( 30 MCGML ) 07252013
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 5 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103770 0 3 6191998 50 MGVIAL ( 50 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
103770 0 4 6191998 100 MGVIAL ( 100 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name INTRON A
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103132 0 6 641986 10 MIUML ( 10 MIUML ) 09232013
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103132 0 7 641986 225 MIU15 ML ( 225 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 8 641986 375 MIU15 ML ( 375 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 9 641986 75 MIU15 ML ( 75 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103949 0 5 1192001 675 MCGPEN ( 675 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 6 1192001 108 MCGPEN ( 108 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
March 2018 Page 6 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name PEGINTRON
103949 0 7 1192001 1184 MCGVIAL ( 1184 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 8 1192001 162 MCGPEN ( 162 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 9 1192001 1776 MCGVIAL ( 1776 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 10 1192001 2025 MCGPEN ( 2025 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 11 1192001 222 MCGVIAL ( 222 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No PALATIN TECHNOLOGIES INC 1588
Trade Name NEUTROSPEC TECHNETIUM (99M TC)
Proper Name FANOLESOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103928 0 1 722004 025 MGVIAL ( 025 MGVIAL ) 09222008
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No RECORDATI RARE DISEASES INC 1899
Trade Name ELSPAR
Proper Name ASPARAGINASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
101063 0 1 1101978 10000 IU ( 10000 IUVIAL ) 04092014
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
March 2018 Page 7 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No SCHERING CORP 0994
Trade Name PEGINTRONREBETOL COMBO PACK
Proper Name PEGINTERFERON ALFA-2B AND RIBAVIRIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125196 0 1 6132008 ( 4 (120 MCG05ML) REDIPEN amp 140 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 2 6132008 ( 4 (150 MCG05ML) REDIPEN amp 168 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 3 6132008 ( 4 (150 MCG05ML) REDIPEN amp 196 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 4 6132008 ( 4 (50 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 5 6132008 ( 4 (80 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125422 0 2 10172012 05 MG ( 25 MGML ) 08082017
SOLUTION INTRAVETREAL SINGLE-DOSE VIAL
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125164 0 10 11142007 50 MCGML ( 50 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 8 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
125164 0 11 11142007 100 MCGML ( 100 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 12 11142007 200 MCGML ( 200 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 13 11142007 300 MCGML ( 300 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 14 11142007 400 MCGML ( 400 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 15 11142007 400 MCG06 ML ( 400 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 16 11142007 600 MCGML ( 600 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 17 11142007 600 MCG06 ML ( 600 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 18 11142007 800 MCG06 ML ( 800 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 19 11142007 1000 MCGML ( 1000 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 9 of 9
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103132 0 1 641986 10 MIU ( 10 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL INTRAVENOUS SINGLE-DOSE VIAL
103132 0 2 641986 18 MIU ( 18 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL
103132 0 3 641986 50 MIU ( 50 MIUVIAL )
POWDER INTRAMUSCULAR SUBCUTANEOUS INTRAVENOUS SINGLE-DOSE VIAL
103132 0 4 641986 228 MIU38 ML ( 6 MIUML )
SOLUTION INTRAMUSCULAR SUBCUTANEOUS MULTI-DOSE VIAL
103132 0 5 641986 32 MIU32 ML ( 10 MIUML )
SOLUTION INTRAMUSCULAR SUBCUTANEOUS INTRALESIONAL MULTI-DOSE VIAL
Trade Name KEYTRUDA
Proper Name PEMBROLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125514 0 1 942014 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125514 1 2 1152015 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 0 1 1192001 74 MCG ( 74 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SYLATRON
Proper Name PEGINTERFERON ALFA-2B
March 2018 Page 30 of 42
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 5153 2 3292011 296 MCG ( 296 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 3 3292011 444 MCG ( 444 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 4 3292011 888 MCG ( 888 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name ZINPLAVA
Proper Name BEZLOTOXUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761046 0 1 10212016 1000 MG40 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No MERZ PHARMACEUTICALS GMBH 1830
Trade Name XEOMIN
Proper Name INCOBOTULINUMTOXINA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125360 0 1 7302010
POWDER INTRAMUSCULAR
50 U ( 50 UVIAL )
SINGLE-DOSE VIAL
125360 0 2 7302010
POWDER INTRAMUSCULAR
100 U ( 100 UVIAL )
SINGLE-DOSE VIAL
125360 3 3 11202015
POWDER INTRAMUSCULAR
200 U ( 200 UVIAL )
SINGLE-DOSE VIAL
March 2018 Page 31 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
Trade Name ARZERRA
Proper Name OFATUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125326 0 1 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG5 ML ( 20 MGML )
125326 0 2 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1000 MG50 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
125504 0
COSENTYX
SECUKINUMAB
Approval Date Product
1212015 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
150 MG ( 150 MGVIAL )
125504 0 2 1212015
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MGML ( 150 MGML )
125504 0 3 1212015
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MGML ( 150 MGML )
Trade Name
Proper Name
BLASTN
125290 0
EXTAVIA
INTERFERON BETA-1B
Approval Date Product
8142009 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
03 MG ( 03 MGVIAL )
Trade Name
Proper Name
BLASTN
125319 0
ILARIS
CANAKINUMAB
Approval Date Product
6172009 1
PotencyDosage FormRoutePresentation
180 MGVIAL ( 180 MGVIAL )
March 2018 Page 32 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
125319 88 2 12222016 150 MG ( 150 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
125319 0 3 12222016 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SIMULECT
Proper Name BASILIXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103764 0 1 5121998 10 MG ( 10 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
103764 0 2 5121998 20 MG ( 20 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No NPS PHARMACEUTICALS INC 1908
Trade Name NATPARA
Proper Name PARATHYROID HORMONE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 33 of 42
CDER Billable Biologic Product List
ApplicantLicense No PROMETHEUS LABORATORIES INC 1848
Trade Name PROLEUKIN
Proper Name ALDESLEUKIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103293 0 1 551992 22 MIU ( 22 MIUVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760
Trade Name ARCALYST
Proper Name RILONACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125249 0 1 2272008
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
220MG ( 220MGVIAL )
Trade Name
Proper Name
DUPIXENT
DUPILUMAB
BLASTN
761055 0
Product
1
Approval Date
3282017
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
300 MG2 ML ( 150 MGML )
Trade Name
Proper Name
EYLEA
AFLIBERCEPT
BLASTN
125387 0
Product
1
Approval Date
11182011
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
2 MG005 ML ( 40 MGML )
March 2018 Page 34 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Trade Name ELITEK
Proper Name RASBURICASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103946 0 1 7122002
POWDER INTRAVENOUS SINGLE-DOSE VIAL
15 MG ( 15 MGVIAL )
103946 5020 2 162006
POWDER INTRAVENOUS SINGLE-DOSE VIAL
75 MG ( 75 MGVIAL )
Trade Name
Proper Name
BLASTN
761037 0
KEVZARA
SARILUMAB
Approval Date Product
5222017 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MG114 ML ( 13158 MGML )
761037 0 2 5222017
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MG114 ML ( 17544 MGML )
761037 1 3 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MG114 ML ( 13158 MGML )
761037 1 4 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
200 MG114 ML ( 17544 MGML )
Trade Name
Proper Name
BLASTN
103362 0
LEUKINE
SARGRAMOSTIM
Approval Date Product
351991 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
250 MCG ( 250 MCGVIAL )
103362 0 2 351991
SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL
500 MCGML ( 500 MCGML )
Trade Name PRALUENT
March 2018 Page 35 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Proper Name ALIROCUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125559 0 1 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 2 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 3 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125559 0 4 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name ZALTRAP
Proper Name ZIV-AFLIBERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125418 0 1 832012 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125418 0 2 832012 200 MG8 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SEATTLE GENETICS INC 1853
Trade Name ADCETRIS
Proper Name BRENTUXIMAB VEDOTIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125388 1 1 8192011 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 36 of 42
CDER Billable Biologic Product List
ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593
Trade Name ELAPRASE
Proper Name IDURSULFASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125151 0 1 7242006 6 MG3 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SICOR BIOTECH UAB 1803
Trade Name GRANIX
Proper Name TBO-FILGRASTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125294 0 1 8292012
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
300 MCG0 5 ML ( 600 MCGML )
125294 0 2 8292012
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
480 MCG08 ML ( 600 MCGML )
ApplicantLicense No SMITH AND NEPHEW INC 2004
Trade Name REGRANEX
Proper Name BECAPLERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103691 0 1 12161997
GEL TOPICAL
100 UG ( 100 UGGM )
Trade Name
Proper Name
SANTYL
COLLAGENASE
BLASTN
101995 0
Product
1
Approval Date
641965
PotencyDosage FormRoutePresentation
OINTMENT TOPICAL
30 G amp 90 G TUBE ( 250 UGRAM )
March 2018 Page 37 of 42
CDER Billable Biologic Product List
ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718
Trade Name MYOBLOC
Proper Name RIMABOTULINUM TOXIN B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103846 0 1 1282002
SOLUTION INTRAMUSCULAR
2500 IU05 ML ( 5000 IUML )
SINGLE-DOSE VIAL
103846 0 3 1282002
SOLUTION INTRAMUSCULAR
10000 IU2 ML ( 5000 IUML )
SINGLE-DOSE VIAL
Proper Name RIMABOTULINUMTOXINB
BLASTN
103846 0
Product
2
Approval Date
1282002
PotencyDosage FormRoutePresentation
SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL
5000 IUML ( 5000 IUML )
ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832
Trade Name ZEVALIN
Proper Name IBRITUMOMAB TIUXETAN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125019 0 1 2192002 32 MG2 ML ( 16 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
Trade Name KEPIVANCE
Proper Name PALIFERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125103 0 1 12152004 625 MG ( 625 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name KINERET
Proper Name ANAKINRA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 38 of 42
CDER Billable Biologic Product List
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898
Trade Name ENTYVIO
Proper Name VEDOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125476 0 1 5202014 300 MG ( 300 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No TEVA RESPIRATORY LLC 2047
Trade Name CINQAIR
Proper Name RESLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761033 0 1 3232016 100 MG10 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No THERATECHNOLOGIES INC 2091
Trade Name TROGARZO
Proper Name IBALIZUMAB-UIYK
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761065 0 1 362018 200 MG133 ML ( 150 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 39 of 42
CDER Billable Biologic Product List
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
0375 MG03 ML ( 125 MGML )2222017 125422 038 1
ApplicantLicense No UCB INC 1736
Trade Name CIMZIA
Proper Name CERTOLIZUMAB PEGOL
BLASTN Approval Date PotencyDosage FormRoutePresentation Product
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
200 MG ( 200 MGVIAL ) 4222008 125160 0 1
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )5132009 125160 080 2
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
Trade Name CRYSVITA
Proper Name BUROSUMAB-TWZA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761068 0 1 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
10 MGML ( 10 MGML )
761068 0 2 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
20 MGML ( 20 MGML )
761068 0
Trade Name
Proper Name
BLASTN
March 2018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML ) 4172018 3
MEPSEVII
VESTRONIDASE ALFA-VJBK
Approval Date PotencyDosage FormRoutePresentation Product
Page 40 of 42
CDER Billable Biologic Product List
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
761047 0 1 11152017 10 MG5 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No UNITED THERAPEUTICS CORP 1993
Trade Name UNITUXIN
Proper Name DINUTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125516 0 1 3102015 175 MG5 ML ( 35 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053
Trade Name SILIQ
Proper Name BRODALUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761032 0 1 2152017 210 MG15 ML ( 140 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 41 of 42
CDER Billable Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No WYETH PHARMACEUTICALS INC 0003
Trade Name BESPONSA
Proper Name INOTUZUMAB OZOGAMICIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761040 0 1 8172017 09 MG ( 09 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 42 of 42
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 1 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
9172001 103951 0 26
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
200 MCGML ( 200 MCGML ) 09272012
103951 0 27 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
200 MCG04 ML ( 500 MCGML ) 09272012
103951 0 28 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
300 MCGML ( 300 MCGML ) 09272012
103951 0 29 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
300 MCG06 ML ( 500 MCGML ) 09272012
103951 0 30 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
500 MCGML ( 500 MCGML ) 09272012
ApplicantLicense No ASTELLAS PHARMACEUTICALS US INC 1748
Trade Name AMEVIVE
Proper Name ALEFACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125036 0 1 1302003 75 MGVIAL ( 75 MGVIAL ) 09242008
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
125036 0 2 1302003 15 MGVIAL ( 15 MGVIAL ) 09282012
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No BOEHRINGER INGELHEIM PHARMA KG 1251
Trade Name VERLUMA
Proper Name NOFETUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103769 0 1 10131998 10 MGML ( 10 MGML ) 08132013
INTRAVENOUS
March 2018 Page 2 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No CENTOCOR ORTHO BIOTECH PRODUCTS LP 1824
Trade Name ORTHOCLONE OKT3
Proper Name MUROMONAB-CD3
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103463 0 1 9141992 1 MGML ( 1 MGML ) 01112012
SOLUTION INTRAVENOUS AMPULE
ApplicantLicense No EISAI INCORPORATED 1862
Trade Name ONTAK
Proper Name DENILEUKIN DIFTITOX
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103767 0 1 251999 300 MCG2 ML ( 150 MCGML ) 01302014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No ELI LILLY AND CO 1611
Trade Name XIGRIS
Proper Name DROTRECOGIN ALFA (ACTIVATED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125029 0 1 11212001 5 MGVIAL ( 5 MGVIAL ) 10262011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125029 0 2 11212001 20 MGVIAL ( 20 MGVIAL ) 10102011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GENENTECH INC 1048
Trade Name RAPTIVA
Proper Name EFALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125075 0 1 10272003 125 MGVIAL ( 125 MGVIAL ) 09012009
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
March 2018 Page 3 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103976 0 2 6202003 125 MGVIAL ( 125 MGVIAL ) 08252016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103948 0 3 572001 10 MGVIAL ( 10 MGVIAL ) 07062011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name MYOZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125141 0 1 4282006 50 MGVIAL ( 50 MGVIAL ) 10172014
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name BEXXAR THERAPEUTIC REGIME
Proper Name TOSITUMOMAB AND IODINE I-131 TOSITUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125011 0 1 6272003 01 MGML I-131 TOSITUMOMAB ( 01 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 2 6272003 11 MGML I-131 TOSITUMOMAB ( 11 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 3 6272003 14 MGML TOSITUMOMAB ( 14 MGML 03102014 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 4 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No HEMISPHERX BIOPHARMA INC 1703
Trade Name ALFERON N INJECTION
Proper Name INTERFERON ALFA-N3 (HUMAN LEUKOCYTE DERIVED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103158 0 1 10101989 5 MIUVIAL ( 5 MIUVIAL ) 06272013
SOLUTION INTRALESIONAL MULTI-DOSE VIAL
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name ROFERON A
Proper Name INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103145 0 1 641986 3 MIU05 ML ( 3 MIU05 ML ) 06012009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name ZENAPAX
Proper Name DACLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103749 0 1 12101997 25 MG5 ML ( 25 MG5 ML ) 07072011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No KADMON PHARMACEUTICALS LLC 1867
Trade Name INFERGEN
Proper Name INTERFERON ALFACON-1
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103663 0 1 1061997 9 MCG03 ML ( 30 MCGML ) 07252013
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 5 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103770 0 3 6191998 50 MGVIAL ( 50 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
103770 0 4 6191998 100 MGVIAL ( 100 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name INTRON A
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103132 0 6 641986 10 MIUML ( 10 MIUML ) 09232013
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103132 0 7 641986 225 MIU15 ML ( 225 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 8 641986 375 MIU15 ML ( 375 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 9 641986 75 MIU15 ML ( 75 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103949 0 5 1192001 675 MCGPEN ( 675 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 6 1192001 108 MCGPEN ( 108 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
March 2018 Page 6 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name PEGINTRON
103949 0 7 1192001 1184 MCGVIAL ( 1184 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 8 1192001 162 MCGPEN ( 162 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 9 1192001 1776 MCGVIAL ( 1776 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 10 1192001 2025 MCGPEN ( 2025 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 11 1192001 222 MCGVIAL ( 222 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No PALATIN TECHNOLOGIES INC 1588
Trade Name NEUTROSPEC TECHNETIUM (99M TC)
Proper Name FANOLESOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103928 0 1 722004 025 MGVIAL ( 025 MGVIAL ) 09222008
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No RECORDATI RARE DISEASES INC 1899
Trade Name ELSPAR
Proper Name ASPARAGINASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
101063 0 1 1101978 10000 IU ( 10000 IUVIAL ) 04092014
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
March 2018 Page 7 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No SCHERING CORP 0994
Trade Name PEGINTRONREBETOL COMBO PACK
Proper Name PEGINTERFERON ALFA-2B AND RIBAVIRIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125196 0 1 6132008 ( 4 (120 MCG05ML) REDIPEN amp 140 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 2 6132008 ( 4 (150 MCG05ML) REDIPEN amp 168 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 3 6132008 ( 4 (150 MCG05ML) REDIPEN amp 196 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 4 6132008 ( 4 (50 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 5 6132008 ( 4 (80 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125422 0 2 10172012 05 MG ( 25 MGML ) 08082017
SOLUTION INTRAVETREAL SINGLE-DOSE VIAL
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125164 0 10 11142007 50 MCGML ( 50 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 8 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
125164 0 11 11142007 100 MCGML ( 100 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 12 11142007 200 MCGML ( 200 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 13 11142007 300 MCGML ( 300 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 14 11142007 400 MCGML ( 400 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 15 11142007 400 MCG06 ML ( 400 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 16 11142007 600 MCGML ( 600 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 17 11142007 600 MCG06 ML ( 600 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 18 11142007 800 MCG06 ML ( 800 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 19 11142007 1000 MCGML ( 1000 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 9 of 9
CDER Billable Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103949 5153 2 3292011 296 MCG ( 296 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 3 3292011 444 MCG ( 444 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 5153 4 3292011 888 MCG ( 888 MCGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name ZINPLAVA
Proper Name BEZLOTOXUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761046 0 1 10212016 1000 MG40 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No MERZ PHARMACEUTICALS GMBH 1830
Trade Name XEOMIN
Proper Name INCOBOTULINUMTOXINA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125360 0 1 7302010
POWDER INTRAMUSCULAR
50 U ( 50 UVIAL )
SINGLE-DOSE VIAL
125360 0 2 7302010
POWDER INTRAMUSCULAR
100 U ( 100 UVIAL )
SINGLE-DOSE VIAL
125360 3 3 11202015
POWDER INTRAMUSCULAR
200 U ( 200 UVIAL )
SINGLE-DOSE VIAL
March 2018 Page 31 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
Trade Name ARZERRA
Proper Name OFATUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125326 0 1 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG5 ML ( 20 MGML )
125326 0 2 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1000 MG50 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
125504 0
COSENTYX
SECUKINUMAB
Approval Date Product
1212015 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
150 MG ( 150 MGVIAL )
125504 0 2 1212015
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MGML ( 150 MGML )
125504 0 3 1212015
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MGML ( 150 MGML )
Trade Name
Proper Name
BLASTN
125290 0
EXTAVIA
INTERFERON BETA-1B
Approval Date Product
8142009 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
03 MG ( 03 MGVIAL )
Trade Name
Proper Name
BLASTN
125319 0
ILARIS
CANAKINUMAB
Approval Date Product
6172009 1
PotencyDosage FormRoutePresentation
180 MGVIAL ( 180 MGVIAL )
March 2018 Page 32 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
125319 88 2 12222016 150 MG ( 150 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
125319 0 3 12222016 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SIMULECT
Proper Name BASILIXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103764 0 1 5121998 10 MG ( 10 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
103764 0 2 5121998 20 MG ( 20 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No NPS PHARMACEUTICALS INC 1908
Trade Name NATPARA
Proper Name PARATHYROID HORMONE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 33 of 42
CDER Billable Biologic Product List
ApplicantLicense No PROMETHEUS LABORATORIES INC 1848
Trade Name PROLEUKIN
Proper Name ALDESLEUKIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103293 0 1 551992 22 MIU ( 22 MIUVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760
Trade Name ARCALYST
Proper Name RILONACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125249 0 1 2272008
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
220MG ( 220MGVIAL )
Trade Name
Proper Name
DUPIXENT
DUPILUMAB
BLASTN
761055 0
Product
1
Approval Date
3282017
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
300 MG2 ML ( 150 MGML )
Trade Name
Proper Name
EYLEA
AFLIBERCEPT
BLASTN
125387 0
Product
1
Approval Date
11182011
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
2 MG005 ML ( 40 MGML )
March 2018 Page 34 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Trade Name ELITEK
Proper Name RASBURICASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103946 0 1 7122002
POWDER INTRAVENOUS SINGLE-DOSE VIAL
15 MG ( 15 MGVIAL )
103946 5020 2 162006
POWDER INTRAVENOUS SINGLE-DOSE VIAL
75 MG ( 75 MGVIAL )
Trade Name
Proper Name
BLASTN
761037 0
KEVZARA
SARILUMAB
Approval Date Product
5222017 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MG114 ML ( 13158 MGML )
761037 0 2 5222017
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MG114 ML ( 17544 MGML )
761037 1 3 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MG114 ML ( 13158 MGML )
761037 1 4 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
200 MG114 ML ( 17544 MGML )
Trade Name
Proper Name
BLASTN
103362 0
LEUKINE
SARGRAMOSTIM
Approval Date Product
351991 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
250 MCG ( 250 MCGVIAL )
103362 0 2 351991
SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL
500 MCGML ( 500 MCGML )
Trade Name PRALUENT
March 2018 Page 35 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Proper Name ALIROCUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125559 0 1 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 2 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 3 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125559 0 4 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name ZALTRAP
Proper Name ZIV-AFLIBERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125418 0 1 832012 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125418 0 2 832012 200 MG8 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SEATTLE GENETICS INC 1853
Trade Name ADCETRIS
Proper Name BRENTUXIMAB VEDOTIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125388 1 1 8192011 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 36 of 42
CDER Billable Biologic Product List
ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593
Trade Name ELAPRASE
Proper Name IDURSULFASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125151 0 1 7242006 6 MG3 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SICOR BIOTECH UAB 1803
Trade Name GRANIX
Proper Name TBO-FILGRASTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125294 0 1 8292012
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
300 MCG0 5 ML ( 600 MCGML )
125294 0 2 8292012
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
480 MCG08 ML ( 600 MCGML )
ApplicantLicense No SMITH AND NEPHEW INC 2004
Trade Name REGRANEX
Proper Name BECAPLERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103691 0 1 12161997
GEL TOPICAL
100 UG ( 100 UGGM )
Trade Name
Proper Name
SANTYL
COLLAGENASE
BLASTN
101995 0
Product
1
Approval Date
641965
PotencyDosage FormRoutePresentation
OINTMENT TOPICAL
30 G amp 90 G TUBE ( 250 UGRAM )
March 2018 Page 37 of 42
CDER Billable Biologic Product List
ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718
Trade Name MYOBLOC
Proper Name RIMABOTULINUM TOXIN B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103846 0 1 1282002
SOLUTION INTRAMUSCULAR
2500 IU05 ML ( 5000 IUML )
SINGLE-DOSE VIAL
103846 0 3 1282002
SOLUTION INTRAMUSCULAR
10000 IU2 ML ( 5000 IUML )
SINGLE-DOSE VIAL
Proper Name RIMABOTULINUMTOXINB
BLASTN
103846 0
Product
2
Approval Date
1282002
PotencyDosage FormRoutePresentation
SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL
5000 IUML ( 5000 IUML )
ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832
Trade Name ZEVALIN
Proper Name IBRITUMOMAB TIUXETAN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125019 0 1 2192002 32 MG2 ML ( 16 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
Trade Name KEPIVANCE
Proper Name PALIFERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125103 0 1 12152004 625 MG ( 625 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name KINERET
Proper Name ANAKINRA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 38 of 42
CDER Billable Biologic Product List
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898
Trade Name ENTYVIO
Proper Name VEDOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125476 0 1 5202014 300 MG ( 300 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No TEVA RESPIRATORY LLC 2047
Trade Name CINQAIR
Proper Name RESLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761033 0 1 3232016 100 MG10 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No THERATECHNOLOGIES INC 2091
Trade Name TROGARZO
Proper Name IBALIZUMAB-UIYK
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761065 0 1 362018 200 MG133 ML ( 150 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 39 of 42
CDER Billable Biologic Product List
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
0375 MG03 ML ( 125 MGML )2222017 125422 038 1
ApplicantLicense No UCB INC 1736
Trade Name CIMZIA
Proper Name CERTOLIZUMAB PEGOL
BLASTN Approval Date PotencyDosage FormRoutePresentation Product
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
200 MG ( 200 MGVIAL ) 4222008 125160 0 1
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )5132009 125160 080 2
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
Trade Name CRYSVITA
Proper Name BUROSUMAB-TWZA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761068 0 1 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
10 MGML ( 10 MGML )
761068 0 2 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
20 MGML ( 20 MGML )
761068 0
Trade Name
Proper Name
BLASTN
March 2018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML ) 4172018 3
MEPSEVII
VESTRONIDASE ALFA-VJBK
Approval Date PotencyDosage FormRoutePresentation Product
Page 40 of 42
CDER Billable Biologic Product List
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
761047 0 1 11152017 10 MG5 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No UNITED THERAPEUTICS CORP 1993
Trade Name UNITUXIN
Proper Name DINUTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125516 0 1 3102015 175 MG5 ML ( 35 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053
Trade Name SILIQ
Proper Name BRODALUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761032 0 1 2152017 210 MG15 ML ( 140 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 41 of 42
CDER Billable Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No WYETH PHARMACEUTICALS INC 0003
Trade Name BESPONSA
Proper Name INOTUZUMAB OZOGAMICIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761040 0 1 8172017 09 MG ( 09 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 42 of 42
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 1 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
9172001 103951 0 26
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
200 MCGML ( 200 MCGML ) 09272012
103951 0 27 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
200 MCG04 ML ( 500 MCGML ) 09272012
103951 0 28 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
300 MCGML ( 300 MCGML ) 09272012
103951 0 29 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
300 MCG06 ML ( 500 MCGML ) 09272012
103951 0 30 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
500 MCGML ( 500 MCGML ) 09272012
ApplicantLicense No ASTELLAS PHARMACEUTICALS US INC 1748
Trade Name AMEVIVE
Proper Name ALEFACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125036 0 1 1302003 75 MGVIAL ( 75 MGVIAL ) 09242008
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
125036 0 2 1302003 15 MGVIAL ( 15 MGVIAL ) 09282012
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No BOEHRINGER INGELHEIM PHARMA KG 1251
Trade Name VERLUMA
Proper Name NOFETUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103769 0 1 10131998 10 MGML ( 10 MGML ) 08132013
INTRAVENOUS
March 2018 Page 2 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No CENTOCOR ORTHO BIOTECH PRODUCTS LP 1824
Trade Name ORTHOCLONE OKT3
Proper Name MUROMONAB-CD3
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103463 0 1 9141992 1 MGML ( 1 MGML ) 01112012
SOLUTION INTRAVENOUS AMPULE
ApplicantLicense No EISAI INCORPORATED 1862
Trade Name ONTAK
Proper Name DENILEUKIN DIFTITOX
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103767 0 1 251999 300 MCG2 ML ( 150 MCGML ) 01302014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No ELI LILLY AND CO 1611
Trade Name XIGRIS
Proper Name DROTRECOGIN ALFA (ACTIVATED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125029 0 1 11212001 5 MGVIAL ( 5 MGVIAL ) 10262011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125029 0 2 11212001 20 MGVIAL ( 20 MGVIAL ) 10102011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GENENTECH INC 1048
Trade Name RAPTIVA
Proper Name EFALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125075 0 1 10272003 125 MGVIAL ( 125 MGVIAL ) 09012009
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
March 2018 Page 3 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103976 0 2 6202003 125 MGVIAL ( 125 MGVIAL ) 08252016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103948 0 3 572001 10 MGVIAL ( 10 MGVIAL ) 07062011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name MYOZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125141 0 1 4282006 50 MGVIAL ( 50 MGVIAL ) 10172014
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name BEXXAR THERAPEUTIC REGIME
Proper Name TOSITUMOMAB AND IODINE I-131 TOSITUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125011 0 1 6272003 01 MGML I-131 TOSITUMOMAB ( 01 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 2 6272003 11 MGML I-131 TOSITUMOMAB ( 11 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 3 6272003 14 MGML TOSITUMOMAB ( 14 MGML 03102014 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 4 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No HEMISPHERX BIOPHARMA INC 1703
Trade Name ALFERON N INJECTION
Proper Name INTERFERON ALFA-N3 (HUMAN LEUKOCYTE DERIVED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103158 0 1 10101989 5 MIUVIAL ( 5 MIUVIAL ) 06272013
SOLUTION INTRALESIONAL MULTI-DOSE VIAL
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name ROFERON A
Proper Name INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103145 0 1 641986 3 MIU05 ML ( 3 MIU05 ML ) 06012009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name ZENAPAX
Proper Name DACLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103749 0 1 12101997 25 MG5 ML ( 25 MG5 ML ) 07072011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No KADMON PHARMACEUTICALS LLC 1867
Trade Name INFERGEN
Proper Name INTERFERON ALFACON-1
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103663 0 1 1061997 9 MCG03 ML ( 30 MCGML ) 07252013
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 5 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103770 0 3 6191998 50 MGVIAL ( 50 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
103770 0 4 6191998 100 MGVIAL ( 100 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name INTRON A
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103132 0 6 641986 10 MIUML ( 10 MIUML ) 09232013
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103132 0 7 641986 225 MIU15 ML ( 225 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 8 641986 375 MIU15 ML ( 375 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 9 641986 75 MIU15 ML ( 75 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103949 0 5 1192001 675 MCGPEN ( 675 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 6 1192001 108 MCGPEN ( 108 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
March 2018 Page 6 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name PEGINTRON
103949 0 7 1192001 1184 MCGVIAL ( 1184 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 8 1192001 162 MCGPEN ( 162 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 9 1192001 1776 MCGVIAL ( 1776 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 10 1192001 2025 MCGPEN ( 2025 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 11 1192001 222 MCGVIAL ( 222 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No PALATIN TECHNOLOGIES INC 1588
Trade Name NEUTROSPEC TECHNETIUM (99M TC)
Proper Name FANOLESOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103928 0 1 722004 025 MGVIAL ( 025 MGVIAL ) 09222008
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No RECORDATI RARE DISEASES INC 1899
Trade Name ELSPAR
Proper Name ASPARAGINASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
101063 0 1 1101978 10000 IU ( 10000 IUVIAL ) 04092014
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
March 2018 Page 7 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No SCHERING CORP 0994
Trade Name PEGINTRONREBETOL COMBO PACK
Proper Name PEGINTERFERON ALFA-2B AND RIBAVIRIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125196 0 1 6132008 ( 4 (120 MCG05ML) REDIPEN amp 140 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 2 6132008 ( 4 (150 MCG05ML) REDIPEN amp 168 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 3 6132008 ( 4 (150 MCG05ML) REDIPEN amp 196 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 4 6132008 ( 4 (50 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 5 6132008 ( 4 (80 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125422 0 2 10172012 05 MG ( 25 MGML ) 08082017
SOLUTION INTRAVETREAL SINGLE-DOSE VIAL
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125164 0 10 11142007 50 MCGML ( 50 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 8 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
125164 0 11 11142007 100 MCGML ( 100 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 12 11142007 200 MCGML ( 200 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 13 11142007 300 MCGML ( 300 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 14 11142007 400 MCGML ( 400 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 15 11142007 400 MCG06 ML ( 400 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 16 11142007 600 MCGML ( 600 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 17 11142007 600 MCG06 ML ( 600 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 18 11142007 800 MCG06 ML ( 800 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 19 11142007 1000 MCGML ( 1000 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 9 of 9
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
Trade Name ARZERRA
Proper Name OFATUMUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125326 0 1 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
100 MG5 ML ( 20 MGML )
125326 0 2 10262009
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
1000 MG50 ML ( 20 MGML )
Trade Name
Proper Name
BLASTN
125504 0
COSENTYX
SECUKINUMAB
Approval Date Product
1212015 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
150 MG ( 150 MGVIAL )
125504 0 2 1212015
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MGML ( 150 MGML )
125504 0 3 1212015
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MGML ( 150 MGML )
Trade Name
Proper Name
BLASTN
125290 0
EXTAVIA
INTERFERON BETA-1B
Approval Date Product
8142009 1
PotencyDosage FormRoutePresentation
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
03 MG ( 03 MGVIAL )
Trade Name
Proper Name
BLASTN
125319 0
ILARIS
CANAKINUMAB
Approval Date Product
6172009 1
PotencyDosage FormRoutePresentation
180 MGVIAL ( 180 MGVIAL )
March 2018 Page 32 of 42
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
125319 88 2 12222016 150 MG ( 150 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
125319 0 3 12222016 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SIMULECT
Proper Name BASILIXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103764 0 1 5121998 10 MG ( 10 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
103764 0 2 5121998 20 MG ( 20 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No NPS PHARMACEUTICALS INC 1908
Trade Name NATPARA
Proper Name PARATHYROID HORMONE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 33 of 42
CDER Billable Biologic Product List
ApplicantLicense No PROMETHEUS LABORATORIES INC 1848
Trade Name PROLEUKIN
Proper Name ALDESLEUKIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103293 0 1 551992 22 MIU ( 22 MIUVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760
Trade Name ARCALYST
Proper Name RILONACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125249 0 1 2272008
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
220MG ( 220MGVIAL )
Trade Name
Proper Name
DUPIXENT
DUPILUMAB
BLASTN
761055 0
Product
1
Approval Date
3282017
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
300 MG2 ML ( 150 MGML )
Trade Name
Proper Name
EYLEA
AFLIBERCEPT
BLASTN
125387 0
Product
1
Approval Date
11182011
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
2 MG005 ML ( 40 MGML )
March 2018 Page 34 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Trade Name ELITEK
Proper Name RASBURICASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103946 0 1 7122002
POWDER INTRAVENOUS SINGLE-DOSE VIAL
15 MG ( 15 MGVIAL )
103946 5020 2 162006
POWDER INTRAVENOUS SINGLE-DOSE VIAL
75 MG ( 75 MGVIAL )
Trade Name
Proper Name
BLASTN
761037 0
KEVZARA
SARILUMAB
Approval Date Product
5222017 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MG114 ML ( 13158 MGML )
761037 0 2 5222017
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MG114 ML ( 17544 MGML )
761037 1 3 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MG114 ML ( 13158 MGML )
761037 1 4 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
200 MG114 ML ( 17544 MGML )
Trade Name
Proper Name
BLASTN
103362 0
LEUKINE
SARGRAMOSTIM
Approval Date Product
351991 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
250 MCG ( 250 MCGVIAL )
103362 0 2 351991
SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL
500 MCGML ( 500 MCGML )
Trade Name PRALUENT
March 2018 Page 35 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Proper Name ALIROCUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125559 0 1 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 2 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 3 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125559 0 4 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name ZALTRAP
Proper Name ZIV-AFLIBERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125418 0 1 832012 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125418 0 2 832012 200 MG8 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SEATTLE GENETICS INC 1853
Trade Name ADCETRIS
Proper Name BRENTUXIMAB VEDOTIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125388 1 1 8192011 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 36 of 42
CDER Billable Biologic Product List
ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593
Trade Name ELAPRASE
Proper Name IDURSULFASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125151 0 1 7242006 6 MG3 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SICOR BIOTECH UAB 1803
Trade Name GRANIX
Proper Name TBO-FILGRASTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125294 0 1 8292012
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
300 MCG0 5 ML ( 600 MCGML )
125294 0 2 8292012
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
480 MCG08 ML ( 600 MCGML )
ApplicantLicense No SMITH AND NEPHEW INC 2004
Trade Name REGRANEX
Proper Name BECAPLERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103691 0 1 12161997
GEL TOPICAL
100 UG ( 100 UGGM )
Trade Name
Proper Name
SANTYL
COLLAGENASE
BLASTN
101995 0
Product
1
Approval Date
641965
PotencyDosage FormRoutePresentation
OINTMENT TOPICAL
30 G amp 90 G TUBE ( 250 UGRAM )
March 2018 Page 37 of 42
CDER Billable Biologic Product List
ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718
Trade Name MYOBLOC
Proper Name RIMABOTULINUM TOXIN B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103846 0 1 1282002
SOLUTION INTRAMUSCULAR
2500 IU05 ML ( 5000 IUML )
SINGLE-DOSE VIAL
103846 0 3 1282002
SOLUTION INTRAMUSCULAR
10000 IU2 ML ( 5000 IUML )
SINGLE-DOSE VIAL
Proper Name RIMABOTULINUMTOXINB
BLASTN
103846 0
Product
2
Approval Date
1282002
PotencyDosage FormRoutePresentation
SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL
5000 IUML ( 5000 IUML )
ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832
Trade Name ZEVALIN
Proper Name IBRITUMOMAB TIUXETAN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125019 0 1 2192002 32 MG2 ML ( 16 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
Trade Name KEPIVANCE
Proper Name PALIFERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125103 0 1 12152004 625 MG ( 625 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name KINERET
Proper Name ANAKINRA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 38 of 42
CDER Billable Biologic Product List
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898
Trade Name ENTYVIO
Proper Name VEDOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125476 0 1 5202014 300 MG ( 300 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No TEVA RESPIRATORY LLC 2047
Trade Name CINQAIR
Proper Name RESLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761033 0 1 3232016 100 MG10 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No THERATECHNOLOGIES INC 2091
Trade Name TROGARZO
Proper Name IBALIZUMAB-UIYK
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761065 0 1 362018 200 MG133 ML ( 150 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 39 of 42
CDER Billable Biologic Product List
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
0375 MG03 ML ( 125 MGML )2222017 125422 038 1
ApplicantLicense No UCB INC 1736
Trade Name CIMZIA
Proper Name CERTOLIZUMAB PEGOL
BLASTN Approval Date PotencyDosage FormRoutePresentation Product
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
200 MG ( 200 MGVIAL ) 4222008 125160 0 1
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )5132009 125160 080 2
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
Trade Name CRYSVITA
Proper Name BUROSUMAB-TWZA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761068 0 1 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
10 MGML ( 10 MGML )
761068 0 2 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
20 MGML ( 20 MGML )
761068 0
Trade Name
Proper Name
BLASTN
March 2018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML ) 4172018 3
MEPSEVII
VESTRONIDASE ALFA-VJBK
Approval Date PotencyDosage FormRoutePresentation Product
Page 40 of 42
CDER Billable Biologic Product List
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
761047 0 1 11152017 10 MG5 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No UNITED THERAPEUTICS CORP 1993
Trade Name UNITUXIN
Proper Name DINUTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125516 0 1 3102015 175 MG5 ML ( 35 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053
Trade Name SILIQ
Proper Name BRODALUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761032 0 1 2152017 210 MG15 ML ( 140 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 41 of 42
CDER Billable Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No WYETH PHARMACEUTICALS INC 0003
Trade Name BESPONSA
Proper Name INOTUZUMAB OZOGAMICIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761040 0 1 8172017 09 MG ( 09 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 42 of 42
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 1 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
9172001 103951 0 26
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
200 MCGML ( 200 MCGML ) 09272012
103951 0 27 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
200 MCG04 ML ( 500 MCGML ) 09272012
103951 0 28 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
300 MCGML ( 300 MCGML ) 09272012
103951 0 29 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
300 MCG06 ML ( 500 MCGML ) 09272012
103951 0 30 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
500 MCGML ( 500 MCGML ) 09272012
ApplicantLicense No ASTELLAS PHARMACEUTICALS US INC 1748
Trade Name AMEVIVE
Proper Name ALEFACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125036 0 1 1302003 75 MGVIAL ( 75 MGVIAL ) 09242008
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
125036 0 2 1302003 15 MGVIAL ( 15 MGVIAL ) 09282012
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No BOEHRINGER INGELHEIM PHARMA KG 1251
Trade Name VERLUMA
Proper Name NOFETUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103769 0 1 10131998 10 MGML ( 10 MGML ) 08132013
INTRAVENOUS
March 2018 Page 2 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No CENTOCOR ORTHO BIOTECH PRODUCTS LP 1824
Trade Name ORTHOCLONE OKT3
Proper Name MUROMONAB-CD3
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103463 0 1 9141992 1 MGML ( 1 MGML ) 01112012
SOLUTION INTRAVENOUS AMPULE
ApplicantLicense No EISAI INCORPORATED 1862
Trade Name ONTAK
Proper Name DENILEUKIN DIFTITOX
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103767 0 1 251999 300 MCG2 ML ( 150 MCGML ) 01302014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No ELI LILLY AND CO 1611
Trade Name XIGRIS
Proper Name DROTRECOGIN ALFA (ACTIVATED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125029 0 1 11212001 5 MGVIAL ( 5 MGVIAL ) 10262011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125029 0 2 11212001 20 MGVIAL ( 20 MGVIAL ) 10102011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GENENTECH INC 1048
Trade Name RAPTIVA
Proper Name EFALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125075 0 1 10272003 125 MGVIAL ( 125 MGVIAL ) 09012009
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
March 2018 Page 3 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103976 0 2 6202003 125 MGVIAL ( 125 MGVIAL ) 08252016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103948 0 3 572001 10 MGVIAL ( 10 MGVIAL ) 07062011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name MYOZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125141 0 1 4282006 50 MGVIAL ( 50 MGVIAL ) 10172014
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name BEXXAR THERAPEUTIC REGIME
Proper Name TOSITUMOMAB AND IODINE I-131 TOSITUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125011 0 1 6272003 01 MGML I-131 TOSITUMOMAB ( 01 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 2 6272003 11 MGML I-131 TOSITUMOMAB ( 11 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 3 6272003 14 MGML TOSITUMOMAB ( 14 MGML 03102014 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 4 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No HEMISPHERX BIOPHARMA INC 1703
Trade Name ALFERON N INJECTION
Proper Name INTERFERON ALFA-N3 (HUMAN LEUKOCYTE DERIVED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103158 0 1 10101989 5 MIUVIAL ( 5 MIUVIAL ) 06272013
SOLUTION INTRALESIONAL MULTI-DOSE VIAL
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name ROFERON A
Proper Name INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103145 0 1 641986 3 MIU05 ML ( 3 MIU05 ML ) 06012009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name ZENAPAX
Proper Name DACLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103749 0 1 12101997 25 MG5 ML ( 25 MG5 ML ) 07072011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No KADMON PHARMACEUTICALS LLC 1867
Trade Name INFERGEN
Proper Name INTERFERON ALFACON-1
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103663 0 1 1061997 9 MCG03 ML ( 30 MCGML ) 07252013
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 5 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103770 0 3 6191998 50 MGVIAL ( 50 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
103770 0 4 6191998 100 MGVIAL ( 100 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name INTRON A
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103132 0 6 641986 10 MIUML ( 10 MIUML ) 09232013
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103132 0 7 641986 225 MIU15 ML ( 225 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 8 641986 375 MIU15 ML ( 375 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 9 641986 75 MIU15 ML ( 75 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103949 0 5 1192001 675 MCGPEN ( 675 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 6 1192001 108 MCGPEN ( 108 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
March 2018 Page 6 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name PEGINTRON
103949 0 7 1192001 1184 MCGVIAL ( 1184 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 8 1192001 162 MCGPEN ( 162 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 9 1192001 1776 MCGVIAL ( 1776 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 10 1192001 2025 MCGPEN ( 2025 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 11 1192001 222 MCGVIAL ( 222 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No PALATIN TECHNOLOGIES INC 1588
Trade Name NEUTROSPEC TECHNETIUM (99M TC)
Proper Name FANOLESOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103928 0 1 722004 025 MGVIAL ( 025 MGVIAL ) 09222008
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No RECORDATI RARE DISEASES INC 1899
Trade Name ELSPAR
Proper Name ASPARAGINASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
101063 0 1 1101978 10000 IU ( 10000 IUVIAL ) 04092014
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
March 2018 Page 7 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No SCHERING CORP 0994
Trade Name PEGINTRONREBETOL COMBO PACK
Proper Name PEGINTERFERON ALFA-2B AND RIBAVIRIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125196 0 1 6132008 ( 4 (120 MCG05ML) REDIPEN amp 140 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 2 6132008 ( 4 (150 MCG05ML) REDIPEN amp 168 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 3 6132008 ( 4 (150 MCG05ML) REDIPEN amp 196 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 4 6132008 ( 4 (50 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 5 6132008 ( 4 (80 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125422 0 2 10172012 05 MG ( 25 MGML ) 08082017
SOLUTION INTRAVETREAL SINGLE-DOSE VIAL
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125164 0 10 11142007 50 MCGML ( 50 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 8 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
125164 0 11 11142007 100 MCGML ( 100 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 12 11142007 200 MCGML ( 200 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 13 11142007 300 MCGML ( 300 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 14 11142007 400 MCGML ( 400 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 15 11142007 400 MCG06 ML ( 400 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 16 11142007 600 MCGML ( 600 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 17 11142007 600 MCG06 ML ( 600 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 18 11142007 800 MCG06 ML ( 800 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 19 11142007 1000 MCGML ( 1000 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 9 of 9
CDER Billable Biologic Product List
ApplicantLicense No NOVARTIS PHARMACEUTICALS CORP 1244
125319 88 2 12222016 150 MG ( 150 MGVIAL )
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
125319 0 3 12222016 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name SIMULECT
Proper Name BASILIXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103764 0 1 5121998 10 MG ( 10 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
103764 0 2 5121998 20 MG ( 20 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No NPS PHARMACEUTICALS INC 1908
Trade Name NATPARA
Proper Name PARATHYROID HORMONE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125511 1 1 1232015 04 MGCARTRIDGE ( 25 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 2 1232015 08 MGCARTRIDGE ( 50 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 3 1232015 121 MGCARTRIDGE ( 75 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
125511 1 4 1232015 161 MGCARTRIDGE ( 100 MCGDOSE )
POWDER SUBCUTANEOUS AUTOINJECTOR
March 2018 Page 33 of 42
CDER Billable Biologic Product List
ApplicantLicense No PROMETHEUS LABORATORIES INC 1848
Trade Name PROLEUKIN
Proper Name ALDESLEUKIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103293 0 1 551992 22 MIU ( 22 MIUVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760
Trade Name ARCALYST
Proper Name RILONACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125249 0 1 2272008
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
220MG ( 220MGVIAL )
Trade Name
Proper Name
DUPIXENT
DUPILUMAB
BLASTN
761055 0
Product
1
Approval Date
3282017
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
300 MG2 ML ( 150 MGML )
Trade Name
Proper Name
EYLEA
AFLIBERCEPT
BLASTN
125387 0
Product
1
Approval Date
11182011
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
2 MG005 ML ( 40 MGML )
March 2018 Page 34 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Trade Name ELITEK
Proper Name RASBURICASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103946 0 1 7122002
POWDER INTRAVENOUS SINGLE-DOSE VIAL
15 MG ( 15 MGVIAL )
103946 5020 2 162006
POWDER INTRAVENOUS SINGLE-DOSE VIAL
75 MG ( 75 MGVIAL )
Trade Name
Proper Name
BLASTN
761037 0
KEVZARA
SARILUMAB
Approval Date Product
5222017 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MG114 ML ( 13158 MGML )
761037 0 2 5222017
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MG114 ML ( 17544 MGML )
761037 1 3 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MG114 ML ( 13158 MGML )
761037 1 4 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
200 MG114 ML ( 17544 MGML )
Trade Name
Proper Name
BLASTN
103362 0
LEUKINE
SARGRAMOSTIM
Approval Date Product
351991 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
250 MCG ( 250 MCGVIAL )
103362 0 2 351991
SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL
500 MCGML ( 500 MCGML )
Trade Name PRALUENT
March 2018 Page 35 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Proper Name ALIROCUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125559 0 1 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 2 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 3 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125559 0 4 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name ZALTRAP
Proper Name ZIV-AFLIBERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125418 0 1 832012 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125418 0 2 832012 200 MG8 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SEATTLE GENETICS INC 1853
Trade Name ADCETRIS
Proper Name BRENTUXIMAB VEDOTIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125388 1 1 8192011 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 36 of 42
CDER Billable Biologic Product List
ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593
Trade Name ELAPRASE
Proper Name IDURSULFASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125151 0 1 7242006 6 MG3 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SICOR BIOTECH UAB 1803
Trade Name GRANIX
Proper Name TBO-FILGRASTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125294 0 1 8292012
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
300 MCG0 5 ML ( 600 MCGML )
125294 0 2 8292012
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
480 MCG08 ML ( 600 MCGML )
ApplicantLicense No SMITH AND NEPHEW INC 2004
Trade Name REGRANEX
Proper Name BECAPLERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103691 0 1 12161997
GEL TOPICAL
100 UG ( 100 UGGM )
Trade Name
Proper Name
SANTYL
COLLAGENASE
BLASTN
101995 0
Product
1
Approval Date
641965
PotencyDosage FormRoutePresentation
OINTMENT TOPICAL
30 G amp 90 G TUBE ( 250 UGRAM )
March 2018 Page 37 of 42
CDER Billable Biologic Product List
ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718
Trade Name MYOBLOC
Proper Name RIMABOTULINUM TOXIN B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103846 0 1 1282002
SOLUTION INTRAMUSCULAR
2500 IU05 ML ( 5000 IUML )
SINGLE-DOSE VIAL
103846 0 3 1282002
SOLUTION INTRAMUSCULAR
10000 IU2 ML ( 5000 IUML )
SINGLE-DOSE VIAL
Proper Name RIMABOTULINUMTOXINB
BLASTN
103846 0
Product
2
Approval Date
1282002
PotencyDosage FormRoutePresentation
SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL
5000 IUML ( 5000 IUML )
ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832
Trade Name ZEVALIN
Proper Name IBRITUMOMAB TIUXETAN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125019 0 1 2192002 32 MG2 ML ( 16 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
Trade Name KEPIVANCE
Proper Name PALIFERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125103 0 1 12152004 625 MG ( 625 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name KINERET
Proper Name ANAKINRA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 38 of 42
CDER Billable Biologic Product List
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898
Trade Name ENTYVIO
Proper Name VEDOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125476 0 1 5202014 300 MG ( 300 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No TEVA RESPIRATORY LLC 2047
Trade Name CINQAIR
Proper Name RESLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761033 0 1 3232016 100 MG10 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No THERATECHNOLOGIES INC 2091
Trade Name TROGARZO
Proper Name IBALIZUMAB-UIYK
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761065 0 1 362018 200 MG133 ML ( 150 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 39 of 42
CDER Billable Biologic Product List
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
0375 MG03 ML ( 125 MGML )2222017 125422 038 1
ApplicantLicense No UCB INC 1736
Trade Name CIMZIA
Proper Name CERTOLIZUMAB PEGOL
BLASTN Approval Date PotencyDosage FormRoutePresentation Product
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
200 MG ( 200 MGVIAL ) 4222008 125160 0 1
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )5132009 125160 080 2
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
Trade Name CRYSVITA
Proper Name BUROSUMAB-TWZA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761068 0 1 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
10 MGML ( 10 MGML )
761068 0 2 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
20 MGML ( 20 MGML )
761068 0
Trade Name
Proper Name
BLASTN
March 2018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML ) 4172018 3
MEPSEVII
VESTRONIDASE ALFA-VJBK
Approval Date PotencyDosage FormRoutePresentation Product
Page 40 of 42
CDER Billable Biologic Product List
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
761047 0 1 11152017 10 MG5 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No UNITED THERAPEUTICS CORP 1993
Trade Name UNITUXIN
Proper Name DINUTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125516 0 1 3102015 175 MG5 ML ( 35 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053
Trade Name SILIQ
Proper Name BRODALUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761032 0 1 2152017 210 MG15 ML ( 140 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 41 of 42
CDER Billable Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No WYETH PHARMACEUTICALS INC 0003
Trade Name BESPONSA
Proper Name INOTUZUMAB OZOGAMICIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761040 0 1 8172017 09 MG ( 09 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 42 of 42
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 1 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
9172001 103951 0 26
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
200 MCGML ( 200 MCGML ) 09272012
103951 0 27 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
200 MCG04 ML ( 500 MCGML ) 09272012
103951 0 28 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
300 MCGML ( 300 MCGML ) 09272012
103951 0 29 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
300 MCG06 ML ( 500 MCGML ) 09272012
103951 0 30 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
500 MCGML ( 500 MCGML ) 09272012
ApplicantLicense No ASTELLAS PHARMACEUTICALS US INC 1748
Trade Name AMEVIVE
Proper Name ALEFACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125036 0 1 1302003 75 MGVIAL ( 75 MGVIAL ) 09242008
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
125036 0 2 1302003 15 MGVIAL ( 15 MGVIAL ) 09282012
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No BOEHRINGER INGELHEIM PHARMA KG 1251
Trade Name VERLUMA
Proper Name NOFETUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103769 0 1 10131998 10 MGML ( 10 MGML ) 08132013
INTRAVENOUS
March 2018 Page 2 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No CENTOCOR ORTHO BIOTECH PRODUCTS LP 1824
Trade Name ORTHOCLONE OKT3
Proper Name MUROMONAB-CD3
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103463 0 1 9141992 1 MGML ( 1 MGML ) 01112012
SOLUTION INTRAVENOUS AMPULE
ApplicantLicense No EISAI INCORPORATED 1862
Trade Name ONTAK
Proper Name DENILEUKIN DIFTITOX
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103767 0 1 251999 300 MCG2 ML ( 150 MCGML ) 01302014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No ELI LILLY AND CO 1611
Trade Name XIGRIS
Proper Name DROTRECOGIN ALFA (ACTIVATED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125029 0 1 11212001 5 MGVIAL ( 5 MGVIAL ) 10262011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125029 0 2 11212001 20 MGVIAL ( 20 MGVIAL ) 10102011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GENENTECH INC 1048
Trade Name RAPTIVA
Proper Name EFALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125075 0 1 10272003 125 MGVIAL ( 125 MGVIAL ) 09012009
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
March 2018 Page 3 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103976 0 2 6202003 125 MGVIAL ( 125 MGVIAL ) 08252016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103948 0 3 572001 10 MGVIAL ( 10 MGVIAL ) 07062011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name MYOZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125141 0 1 4282006 50 MGVIAL ( 50 MGVIAL ) 10172014
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name BEXXAR THERAPEUTIC REGIME
Proper Name TOSITUMOMAB AND IODINE I-131 TOSITUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125011 0 1 6272003 01 MGML I-131 TOSITUMOMAB ( 01 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 2 6272003 11 MGML I-131 TOSITUMOMAB ( 11 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 3 6272003 14 MGML TOSITUMOMAB ( 14 MGML 03102014 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 4 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No HEMISPHERX BIOPHARMA INC 1703
Trade Name ALFERON N INJECTION
Proper Name INTERFERON ALFA-N3 (HUMAN LEUKOCYTE DERIVED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103158 0 1 10101989 5 MIUVIAL ( 5 MIUVIAL ) 06272013
SOLUTION INTRALESIONAL MULTI-DOSE VIAL
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name ROFERON A
Proper Name INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103145 0 1 641986 3 MIU05 ML ( 3 MIU05 ML ) 06012009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name ZENAPAX
Proper Name DACLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103749 0 1 12101997 25 MG5 ML ( 25 MG5 ML ) 07072011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No KADMON PHARMACEUTICALS LLC 1867
Trade Name INFERGEN
Proper Name INTERFERON ALFACON-1
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103663 0 1 1061997 9 MCG03 ML ( 30 MCGML ) 07252013
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 5 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103770 0 3 6191998 50 MGVIAL ( 50 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
103770 0 4 6191998 100 MGVIAL ( 100 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name INTRON A
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103132 0 6 641986 10 MIUML ( 10 MIUML ) 09232013
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103132 0 7 641986 225 MIU15 ML ( 225 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 8 641986 375 MIU15 ML ( 375 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 9 641986 75 MIU15 ML ( 75 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103949 0 5 1192001 675 MCGPEN ( 675 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 6 1192001 108 MCGPEN ( 108 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
March 2018 Page 6 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name PEGINTRON
103949 0 7 1192001 1184 MCGVIAL ( 1184 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 8 1192001 162 MCGPEN ( 162 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 9 1192001 1776 MCGVIAL ( 1776 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 10 1192001 2025 MCGPEN ( 2025 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 11 1192001 222 MCGVIAL ( 222 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No PALATIN TECHNOLOGIES INC 1588
Trade Name NEUTROSPEC TECHNETIUM (99M TC)
Proper Name FANOLESOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103928 0 1 722004 025 MGVIAL ( 025 MGVIAL ) 09222008
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No RECORDATI RARE DISEASES INC 1899
Trade Name ELSPAR
Proper Name ASPARAGINASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
101063 0 1 1101978 10000 IU ( 10000 IUVIAL ) 04092014
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
March 2018 Page 7 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No SCHERING CORP 0994
Trade Name PEGINTRONREBETOL COMBO PACK
Proper Name PEGINTERFERON ALFA-2B AND RIBAVIRIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125196 0 1 6132008 ( 4 (120 MCG05ML) REDIPEN amp 140 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 2 6132008 ( 4 (150 MCG05ML) REDIPEN amp 168 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 3 6132008 ( 4 (150 MCG05ML) REDIPEN amp 196 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 4 6132008 ( 4 (50 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 5 6132008 ( 4 (80 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125422 0 2 10172012 05 MG ( 25 MGML ) 08082017
SOLUTION INTRAVETREAL SINGLE-DOSE VIAL
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125164 0 10 11142007 50 MCGML ( 50 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 8 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
125164 0 11 11142007 100 MCGML ( 100 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 12 11142007 200 MCGML ( 200 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 13 11142007 300 MCGML ( 300 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 14 11142007 400 MCGML ( 400 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 15 11142007 400 MCG06 ML ( 400 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 16 11142007 600 MCGML ( 600 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 17 11142007 600 MCG06 ML ( 600 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 18 11142007 800 MCG06 ML ( 800 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 19 11142007 1000 MCGML ( 1000 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 9 of 9
CDER Billable Biologic Product List
ApplicantLicense No PROMETHEUS LABORATORIES INC 1848
Trade Name PROLEUKIN
Proper Name ALDESLEUKIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103293 0 1 551992 22 MIU ( 22 MIUVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No REGENERON PHARMACEUTICALS INC 1760
Trade Name ARCALYST
Proper Name RILONACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125249 0 1 2272008
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
220MG ( 220MGVIAL )
Trade Name
Proper Name
DUPIXENT
DUPILUMAB
BLASTN
761055 0
Product
1
Approval Date
3282017
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
300 MG2 ML ( 150 MGML )
Trade Name
Proper Name
EYLEA
AFLIBERCEPT
BLASTN
125387 0
Product
1
Approval Date
11182011
PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
2 MG005 ML ( 40 MGML )
March 2018 Page 34 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Trade Name ELITEK
Proper Name RASBURICASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103946 0 1 7122002
POWDER INTRAVENOUS SINGLE-DOSE VIAL
15 MG ( 15 MGVIAL )
103946 5020 2 162006
POWDER INTRAVENOUS SINGLE-DOSE VIAL
75 MG ( 75 MGVIAL )
Trade Name
Proper Name
BLASTN
761037 0
KEVZARA
SARILUMAB
Approval Date Product
5222017 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MG114 ML ( 13158 MGML )
761037 0 2 5222017
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MG114 ML ( 17544 MGML )
761037 1 3 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MG114 ML ( 13158 MGML )
761037 1 4 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
200 MG114 ML ( 17544 MGML )
Trade Name
Proper Name
BLASTN
103362 0
LEUKINE
SARGRAMOSTIM
Approval Date Product
351991 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
250 MCG ( 250 MCGVIAL )
103362 0 2 351991
SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL
500 MCGML ( 500 MCGML )
Trade Name PRALUENT
March 2018 Page 35 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Proper Name ALIROCUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125559 0 1 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 2 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 3 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125559 0 4 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name ZALTRAP
Proper Name ZIV-AFLIBERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125418 0 1 832012 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125418 0 2 832012 200 MG8 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SEATTLE GENETICS INC 1853
Trade Name ADCETRIS
Proper Name BRENTUXIMAB VEDOTIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125388 1 1 8192011 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 36 of 42
CDER Billable Biologic Product List
ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593
Trade Name ELAPRASE
Proper Name IDURSULFASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125151 0 1 7242006 6 MG3 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SICOR BIOTECH UAB 1803
Trade Name GRANIX
Proper Name TBO-FILGRASTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125294 0 1 8292012
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
300 MCG0 5 ML ( 600 MCGML )
125294 0 2 8292012
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
480 MCG08 ML ( 600 MCGML )
ApplicantLicense No SMITH AND NEPHEW INC 2004
Trade Name REGRANEX
Proper Name BECAPLERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103691 0 1 12161997
GEL TOPICAL
100 UG ( 100 UGGM )
Trade Name
Proper Name
SANTYL
COLLAGENASE
BLASTN
101995 0
Product
1
Approval Date
641965
PotencyDosage FormRoutePresentation
OINTMENT TOPICAL
30 G amp 90 G TUBE ( 250 UGRAM )
March 2018 Page 37 of 42
CDER Billable Biologic Product List
ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718
Trade Name MYOBLOC
Proper Name RIMABOTULINUM TOXIN B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103846 0 1 1282002
SOLUTION INTRAMUSCULAR
2500 IU05 ML ( 5000 IUML )
SINGLE-DOSE VIAL
103846 0 3 1282002
SOLUTION INTRAMUSCULAR
10000 IU2 ML ( 5000 IUML )
SINGLE-DOSE VIAL
Proper Name RIMABOTULINUMTOXINB
BLASTN
103846 0
Product
2
Approval Date
1282002
PotencyDosage FormRoutePresentation
SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL
5000 IUML ( 5000 IUML )
ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832
Trade Name ZEVALIN
Proper Name IBRITUMOMAB TIUXETAN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125019 0 1 2192002 32 MG2 ML ( 16 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
Trade Name KEPIVANCE
Proper Name PALIFERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125103 0 1 12152004 625 MG ( 625 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name KINERET
Proper Name ANAKINRA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 38 of 42
CDER Billable Biologic Product List
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898
Trade Name ENTYVIO
Proper Name VEDOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125476 0 1 5202014 300 MG ( 300 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No TEVA RESPIRATORY LLC 2047
Trade Name CINQAIR
Proper Name RESLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761033 0 1 3232016 100 MG10 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No THERATECHNOLOGIES INC 2091
Trade Name TROGARZO
Proper Name IBALIZUMAB-UIYK
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761065 0 1 362018 200 MG133 ML ( 150 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 39 of 42
CDER Billable Biologic Product List
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
0375 MG03 ML ( 125 MGML )2222017 125422 038 1
ApplicantLicense No UCB INC 1736
Trade Name CIMZIA
Proper Name CERTOLIZUMAB PEGOL
BLASTN Approval Date PotencyDosage FormRoutePresentation Product
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
200 MG ( 200 MGVIAL ) 4222008 125160 0 1
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )5132009 125160 080 2
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
Trade Name CRYSVITA
Proper Name BUROSUMAB-TWZA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761068 0 1 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
10 MGML ( 10 MGML )
761068 0 2 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
20 MGML ( 20 MGML )
761068 0
Trade Name
Proper Name
BLASTN
March 2018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML ) 4172018 3
MEPSEVII
VESTRONIDASE ALFA-VJBK
Approval Date PotencyDosage FormRoutePresentation Product
Page 40 of 42
CDER Billable Biologic Product List
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
761047 0 1 11152017 10 MG5 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No UNITED THERAPEUTICS CORP 1993
Trade Name UNITUXIN
Proper Name DINUTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125516 0 1 3102015 175 MG5 ML ( 35 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053
Trade Name SILIQ
Proper Name BRODALUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761032 0 1 2152017 210 MG15 ML ( 140 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 41 of 42
CDER Billable Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No WYETH PHARMACEUTICALS INC 0003
Trade Name BESPONSA
Proper Name INOTUZUMAB OZOGAMICIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761040 0 1 8172017 09 MG ( 09 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 42 of 42
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 1 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
9172001 103951 0 26
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
200 MCGML ( 200 MCGML ) 09272012
103951 0 27 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
200 MCG04 ML ( 500 MCGML ) 09272012
103951 0 28 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
300 MCGML ( 300 MCGML ) 09272012
103951 0 29 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
300 MCG06 ML ( 500 MCGML ) 09272012
103951 0 30 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
500 MCGML ( 500 MCGML ) 09272012
ApplicantLicense No ASTELLAS PHARMACEUTICALS US INC 1748
Trade Name AMEVIVE
Proper Name ALEFACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125036 0 1 1302003 75 MGVIAL ( 75 MGVIAL ) 09242008
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
125036 0 2 1302003 15 MGVIAL ( 15 MGVIAL ) 09282012
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No BOEHRINGER INGELHEIM PHARMA KG 1251
Trade Name VERLUMA
Proper Name NOFETUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103769 0 1 10131998 10 MGML ( 10 MGML ) 08132013
INTRAVENOUS
March 2018 Page 2 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No CENTOCOR ORTHO BIOTECH PRODUCTS LP 1824
Trade Name ORTHOCLONE OKT3
Proper Name MUROMONAB-CD3
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103463 0 1 9141992 1 MGML ( 1 MGML ) 01112012
SOLUTION INTRAVENOUS AMPULE
ApplicantLicense No EISAI INCORPORATED 1862
Trade Name ONTAK
Proper Name DENILEUKIN DIFTITOX
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103767 0 1 251999 300 MCG2 ML ( 150 MCGML ) 01302014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No ELI LILLY AND CO 1611
Trade Name XIGRIS
Proper Name DROTRECOGIN ALFA (ACTIVATED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125029 0 1 11212001 5 MGVIAL ( 5 MGVIAL ) 10262011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125029 0 2 11212001 20 MGVIAL ( 20 MGVIAL ) 10102011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GENENTECH INC 1048
Trade Name RAPTIVA
Proper Name EFALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125075 0 1 10272003 125 MGVIAL ( 125 MGVIAL ) 09012009
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
March 2018 Page 3 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103976 0 2 6202003 125 MGVIAL ( 125 MGVIAL ) 08252016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103948 0 3 572001 10 MGVIAL ( 10 MGVIAL ) 07062011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name MYOZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125141 0 1 4282006 50 MGVIAL ( 50 MGVIAL ) 10172014
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name BEXXAR THERAPEUTIC REGIME
Proper Name TOSITUMOMAB AND IODINE I-131 TOSITUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125011 0 1 6272003 01 MGML I-131 TOSITUMOMAB ( 01 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 2 6272003 11 MGML I-131 TOSITUMOMAB ( 11 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 3 6272003 14 MGML TOSITUMOMAB ( 14 MGML 03102014 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 4 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No HEMISPHERX BIOPHARMA INC 1703
Trade Name ALFERON N INJECTION
Proper Name INTERFERON ALFA-N3 (HUMAN LEUKOCYTE DERIVED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103158 0 1 10101989 5 MIUVIAL ( 5 MIUVIAL ) 06272013
SOLUTION INTRALESIONAL MULTI-DOSE VIAL
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name ROFERON A
Proper Name INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103145 0 1 641986 3 MIU05 ML ( 3 MIU05 ML ) 06012009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name ZENAPAX
Proper Name DACLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103749 0 1 12101997 25 MG5 ML ( 25 MG5 ML ) 07072011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No KADMON PHARMACEUTICALS LLC 1867
Trade Name INFERGEN
Proper Name INTERFERON ALFACON-1
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103663 0 1 1061997 9 MCG03 ML ( 30 MCGML ) 07252013
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 5 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103770 0 3 6191998 50 MGVIAL ( 50 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
103770 0 4 6191998 100 MGVIAL ( 100 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name INTRON A
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103132 0 6 641986 10 MIUML ( 10 MIUML ) 09232013
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103132 0 7 641986 225 MIU15 ML ( 225 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 8 641986 375 MIU15 ML ( 375 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 9 641986 75 MIU15 ML ( 75 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103949 0 5 1192001 675 MCGPEN ( 675 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 6 1192001 108 MCGPEN ( 108 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
March 2018 Page 6 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name PEGINTRON
103949 0 7 1192001 1184 MCGVIAL ( 1184 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 8 1192001 162 MCGPEN ( 162 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 9 1192001 1776 MCGVIAL ( 1776 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 10 1192001 2025 MCGPEN ( 2025 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 11 1192001 222 MCGVIAL ( 222 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No PALATIN TECHNOLOGIES INC 1588
Trade Name NEUTROSPEC TECHNETIUM (99M TC)
Proper Name FANOLESOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103928 0 1 722004 025 MGVIAL ( 025 MGVIAL ) 09222008
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No RECORDATI RARE DISEASES INC 1899
Trade Name ELSPAR
Proper Name ASPARAGINASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
101063 0 1 1101978 10000 IU ( 10000 IUVIAL ) 04092014
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
March 2018 Page 7 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No SCHERING CORP 0994
Trade Name PEGINTRONREBETOL COMBO PACK
Proper Name PEGINTERFERON ALFA-2B AND RIBAVIRIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125196 0 1 6132008 ( 4 (120 MCG05ML) REDIPEN amp 140 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 2 6132008 ( 4 (150 MCG05ML) REDIPEN amp 168 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 3 6132008 ( 4 (150 MCG05ML) REDIPEN amp 196 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 4 6132008 ( 4 (50 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 5 6132008 ( 4 (80 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125422 0 2 10172012 05 MG ( 25 MGML ) 08082017
SOLUTION INTRAVETREAL SINGLE-DOSE VIAL
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125164 0 10 11142007 50 MCGML ( 50 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 8 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
125164 0 11 11142007 100 MCGML ( 100 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 12 11142007 200 MCGML ( 200 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 13 11142007 300 MCGML ( 300 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 14 11142007 400 MCGML ( 400 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 15 11142007 400 MCG06 ML ( 400 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 16 11142007 600 MCGML ( 600 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 17 11142007 600 MCG06 ML ( 600 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 18 11142007 800 MCG06 ML ( 800 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 19 11142007 1000 MCGML ( 1000 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 9 of 9
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Trade Name ELITEK
Proper Name RASBURICASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103946 0 1 7122002
POWDER INTRAVENOUS SINGLE-DOSE VIAL
15 MG ( 15 MGVIAL )
103946 5020 2 162006
POWDER INTRAVENOUS SINGLE-DOSE VIAL
75 MG ( 75 MGVIAL )
Trade Name
Proper Name
BLASTN
761037 0
KEVZARA
SARILUMAB
Approval Date Product
5222017 1
PotencyDosage FormRoutePresentation
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
150 MG114 ML ( 13158 MGML )
761037 0 2 5222017
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MG114 ML ( 17544 MGML )
761037 1 3 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
150 MG114 ML ( 13158 MGML )
761037 1 4 4132018
SOLUTION SUBCUTANEOUS AUTOINJECTOR
200 MG114 ML ( 17544 MGML )
Trade Name
Proper Name
BLASTN
103362 0
LEUKINE
SARGRAMOSTIM
Approval Date Product
351991 1
PotencyDosage FormRoutePresentation
POWDER INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
250 MCG ( 250 MCGVIAL )
103362 0 2 351991
SOLUTION INTRAVENOUSSUBCUTANEOUS MULTI-DOSE VIAL
500 MCGML ( 500 MCGML )
Trade Name PRALUENT
March 2018 Page 35 of 42
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Proper Name ALIROCUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125559 0 1 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 2 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 3 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125559 0 4 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name ZALTRAP
Proper Name ZIV-AFLIBERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125418 0 1 832012 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125418 0 2 832012 200 MG8 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SEATTLE GENETICS INC 1853
Trade Name ADCETRIS
Proper Name BRENTUXIMAB VEDOTIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125388 1 1 8192011 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 36 of 42
CDER Billable Biologic Product List
ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593
Trade Name ELAPRASE
Proper Name IDURSULFASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125151 0 1 7242006 6 MG3 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SICOR BIOTECH UAB 1803
Trade Name GRANIX
Proper Name TBO-FILGRASTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125294 0 1 8292012
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
300 MCG0 5 ML ( 600 MCGML )
125294 0 2 8292012
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
480 MCG08 ML ( 600 MCGML )
ApplicantLicense No SMITH AND NEPHEW INC 2004
Trade Name REGRANEX
Proper Name BECAPLERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103691 0 1 12161997
GEL TOPICAL
100 UG ( 100 UGGM )
Trade Name
Proper Name
SANTYL
COLLAGENASE
BLASTN
101995 0
Product
1
Approval Date
641965
PotencyDosage FormRoutePresentation
OINTMENT TOPICAL
30 G amp 90 G TUBE ( 250 UGRAM )
March 2018 Page 37 of 42
CDER Billable Biologic Product List
ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718
Trade Name MYOBLOC
Proper Name RIMABOTULINUM TOXIN B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103846 0 1 1282002
SOLUTION INTRAMUSCULAR
2500 IU05 ML ( 5000 IUML )
SINGLE-DOSE VIAL
103846 0 3 1282002
SOLUTION INTRAMUSCULAR
10000 IU2 ML ( 5000 IUML )
SINGLE-DOSE VIAL
Proper Name RIMABOTULINUMTOXINB
BLASTN
103846 0
Product
2
Approval Date
1282002
PotencyDosage FormRoutePresentation
SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL
5000 IUML ( 5000 IUML )
ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832
Trade Name ZEVALIN
Proper Name IBRITUMOMAB TIUXETAN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125019 0 1 2192002 32 MG2 ML ( 16 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
Trade Name KEPIVANCE
Proper Name PALIFERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125103 0 1 12152004 625 MG ( 625 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name KINERET
Proper Name ANAKINRA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 38 of 42
CDER Billable Biologic Product List
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898
Trade Name ENTYVIO
Proper Name VEDOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125476 0 1 5202014 300 MG ( 300 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No TEVA RESPIRATORY LLC 2047
Trade Name CINQAIR
Proper Name RESLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761033 0 1 3232016 100 MG10 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No THERATECHNOLOGIES INC 2091
Trade Name TROGARZO
Proper Name IBALIZUMAB-UIYK
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761065 0 1 362018 200 MG133 ML ( 150 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 39 of 42
CDER Billable Biologic Product List
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
0375 MG03 ML ( 125 MGML )2222017 125422 038 1
ApplicantLicense No UCB INC 1736
Trade Name CIMZIA
Proper Name CERTOLIZUMAB PEGOL
BLASTN Approval Date PotencyDosage FormRoutePresentation Product
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
200 MG ( 200 MGVIAL ) 4222008 125160 0 1
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )5132009 125160 080 2
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
Trade Name CRYSVITA
Proper Name BUROSUMAB-TWZA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761068 0 1 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
10 MGML ( 10 MGML )
761068 0 2 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
20 MGML ( 20 MGML )
761068 0
Trade Name
Proper Name
BLASTN
March 2018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML ) 4172018 3
MEPSEVII
VESTRONIDASE ALFA-VJBK
Approval Date PotencyDosage FormRoutePresentation Product
Page 40 of 42
CDER Billable Biologic Product List
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
761047 0 1 11152017 10 MG5 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No UNITED THERAPEUTICS CORP 1993
Trade Name UNITUXIN
Proper Name DINUTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125516 0 1 3102015 175 MG5 ML ( 35 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053
Trade Name SILIQ
Proper Name BRODALUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761032 0 1 2152017 210 MG15 ML ( 140 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 41 of 42
CDER Billable Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No WYETH PHARMACEUTICALS INC 0003
Trade Name BESPONSA
Proper Name INOTUZUMAB OZOGAMICIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761040 0 1 8172017 09 MG ( 09 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 42 of 42
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 1 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
9172001 103951 0 26
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
200 MCGML ( 200 MCGML ) 09272012
103951 0 27 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
200 MCG04 ML ( 500 MCGML ) 09272012
103951 0 28 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
300 MCGML ( 300 MCGML ) 09272012
103951 0 29 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
300 MCG06 ML ( 500 MCGML ) 09272012
103951 0 30 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
500 MCGML ( 500 MCGML ) 09272012
ApplicantLicense No ASTELLAS PHARMACEUTICALS US INC 1748
Trade Name AMEVIVE
Proper Name ALEFACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125036 0 1 1302003 75 MGVIAL ( 75 MGVIAL ) 09242008
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
125036 0 2 1302003 15 MGVIAL ( 15 MGVIAL ) 09282012
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No BOEHRINGER INGELHEIM PHARMA KG 1251
Trade Name VERLUMA
Proper Name NOFETUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103769 0 1 10131998 10 MGML ( 10 MGML ) 08132013
INTRAVENOUS
March 2018 Page 2 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No CENTOCOR ORTHO BIOTECH PRODUCTS LP 1824
Trade Name ORTHOCLONE OKT3
Proper Name MUROMONAB-CD3
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103463 0 1 9141992 1 MGML ( 1 MGML ) 01112012
SOLUTION INTRAVENOUS AMPULE
ApplicantLicense No EISAI INCORPORATED 1862
Trade Name ONTAK
Proper Name DENILEUKIN DIFTITOX
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103767 0 1 251999 300 MCG2 ML ( 150 MCGML ) 01302014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No ELI LILLY AND CO 1611
Trade Name XIGRIS
Proper Name DROTRECOGIN ALFA (ACTIVATED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125029 0 1 11212001 5 MGVIAL ( 5 MGVIAL ) 10262011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125029 0 2 11212001 20 MGVIAL ( 20 MGVIAL ) 10102011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GENENTECH INC 1048
Trade Name RAPTIVA
Proper Name EFALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125075 0 1 10272003 125 MGVIAL ( 125 MGVIAL ) 09012009
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
March 2018 Page 3 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103976 0 2 6202003 125 MGVIAL ( 125 MGVIAL ) 08252016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103948 0 3 572001 10 MGVIAL ( 10 MGVIAL ) 07062011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name MYOZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125141 0 1 4282006 50 MGVIAL ( 50 MGVIAL ) 10172014
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name BEXXAR THERAPEUTIC REGIME
Proper Name TOSITUMOMAB AND IODINE I-131 TOSITUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125011 0 1 6272003 01 MGML I-131 TOSITUMOMAB ( 01 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 2 6272003 11 MGML I-131 TOSITUMOMAB ( 11 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 3 6272003 14 MGML TOSITUMOMAB ( 14 MGML 03102014 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 4 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No HEMISPHERX BIOPHARMA INC 1703
Trade Name ALFERON N INJECTION
Proper Name INTERFERON ALFA-N3 (HUMAN LEUKOCYTE DERIVED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103158 0 1 10101989 5 MIUVIAL ( 5 MIUVIAL ) 06272013
SOLUTION INTRALESIONAL MULTI-DOSE VIAL
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name ROFERON A
Proper Name INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103145 0 1 641986 3 MIU05 ML ( 3 MIU05 ML ) 06012009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name ZENAPAX
Proper Name DACLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103749 0 1 12101997 25 MG5 ML ( 25 MG5 ML ) 07072011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No KADMON PHARMACEUTICALS LLC 1867
Trade Name INFERGEN
Proper Name INTERFERON ALFACON-1
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103663 0 1 1061997 9 MCG03 ML ( 30 MCGML ) 07252013
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 5 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103770 0 3 6191998 50 MGVIAL ( 50 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
103770 0 4 6191998 100 MGVIAL ( 100 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name INTRON A
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103132 0 6 641986 10 MIUML ( 10 MIUML ) 09232013
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103132 0 7 641986 225 MIU15 ML ( 225 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 8 641986 375 MIU15 ML ( 375 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 9 641986 75 MIU15 ML ( 75 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103949 0 5 1192001 675 MCGPEN ( 675 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 6 1192001 108 MCGPEN ( 108 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
March 2018 Page 6 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name PEGINTRON
103949 0 7 1192001 1184 MCGVIAL ( 1184 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 8 1192001 162 MCGPEN ( 162 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 9 1192001 1776 MCGVIAL ( 1776 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 10 1192001 2025 MCGPEN ( 2025 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 11 1192001 222 MCGVIAL ( 222 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No PALATIN TECHNOLOGIES INC 1588
Trade Name NEUTROSPEC TECHNETIUM (99M TC)
Proper Name FANOLESOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103928 0 1 722004 025 MGVIAL ( 025 MGVIAL ) 09222008
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No RECORDATI RARE DISEASES INC 1899
Trade Name ELSPAR
Proper Name ASPARAGINASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
101063 0 1 1101978 10000 IU ( 10000 IUVIAL ) 04092014
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
March 2018 Page 7 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No SCHERING CORP 0994
Trade Name PEGINTRONREBETOL COMBO PACK
Proper Name PEGINTERFERON ALFA-2B AND RIBAVIRIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125196 0 1 6132008 ( 4 (120 MCG05ML) REDIPEN amp 140 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 2 6132008 ( 4 (150 MCG05ML) REDIPEN amp 168 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 3 6132008 ( 4 (150 MCG05ML) REDIPEN amp 196 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 4 6132008 ( 4 (50 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 5 6132008 ( 4 (80 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125422 0 2 10172012 05 MG ( 25 MGML ) 08082017
SOLUTION INTRAVETREAL SINGLE-DOSE VIAL
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125164 0 10 11142007 50 MCGML ( 50 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 8 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
125164 0 11 11142007 100 MCGML ( 100 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 12 11142007 200 MCGML ( 200 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 13 11142007 300 MCGML ( 300 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 14 11142007 400 MCGML ( 400 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 15 11142007 400 MCG06 ML ( 400 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 16 11142007 600 MCGML ( 600 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 17 11142007 600 MCG06 ML ( 600 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 18 11142007 800 MCG06 ML ( 800 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 19 11142007 1000 MCGML ( 1000 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 9 of 9
CDER Billable Biologic Product List
ApplicantLicense No SANOFI AVENTIS US LLC 1752
Proper Name ALIROCUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125559 0 1 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 2 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
125559 0 3 7242015 75 MGML ( 75 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
125559 0 4 7242015 150 MGML ( 150 MGML )
SOLUTION SUBCUTANEOUS AUTOINJECTOR
Trade Name ZALTRAP
Proper Name ZIV-AFLIBERCEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125418 0 1 832012 100 MG4 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125418 0 2 832012 200 MG8 ML ( 25 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SEATTLE GENETICS INC 1853
Trade Name ADCETRIS
Proper Name BRENTUXIMAB VEDOTIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125388 1 1 8192011 50 MG ( 50 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 36 of 42
CDER Billable Biologic Product List
ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593
Trade Name ELAPRASE
Proper Name IDURSULFASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125151 0 1 7242006 6 MG3 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SICOR BIOTECH UAB 1803
Trade Name GRANIX
Proper Name TBO-FILGRASTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125294 0 1 8292012
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
300 MCG0 5 ML ( 600 MCGML )
125294 0 2 8292012
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
480 MCG08 ML ( 600 MCGML )
ApplicantLicense No SMITH AND NEPHEW INC 2004
Trade Name REGRANEX
Proper Name BECAPLERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103691 0 1 12161997
GEL TOPICAL
100 UG ( 100 UGGM )
Trade Name
Proper Name
SANTYL
COLLAGENASE
BLASTN
101995 0
Product
1
Approval Date
641965
PotencyDosage FormRoutePresentation
OINTMENT TOPICAL
30 G amp 90 G TUBE ( 250 UGRAM )
March 2018 Page 37 of 42
CDER Billable Biologic Product List
ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718
Trade Name MYOBLOC
Proper Name RIMABOTULINUM TOXIN B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103846 0 1 1282002
SOLUTION INTRAMUSCULAR
2500 IU05 ML ( 5000 IUML )
SINGLE-DOSE VIAL
103846 0 3 1282002
SOLUTION INTRAMUSCULAR
10000 IU2 ML ( 5000 IUML )
SINGLE-DOSE VIAL
Proper Name RIMABOTULINUMTOXINB
BLASTN
103846 0
Product
2
Approval Date
1282002
PotencyDosage FormRoutePresentation
SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL
5000 IUML ( 5000 IUML )
ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832
Trade Name ZEVALIN
Proper Name IBRITUMOMAB TIUXETAN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125019 0 1 2192002 32 MG2 ML ( 16 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
Trade Name KEPIVANCE
Proper Name PALIFERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125103 0 1 12152004 625 MG ( 625 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name KINERET
Proper Name ANAKINRA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 38 of 42
CDER Billable Biologic Product List
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898
Trade Name ENTYVIO
Proper Name VEDOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125476 0 1 5202014 300 MG ( 300 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No TEVA RESPIRATORY LLC 2047
Trade Name CINQAIR
Proper Name RESLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761033 0 1 3232016 100 MG10 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No THERATECHNOLOGIES INC 2091
Trade Name TROGARZO
Proper Name IBALIZUMAB-UIYK
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761065 0 1 362018 200 MG133 ML ( 150 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 39 of 42
CDER Billable Biologic Product List
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
0375 MG03 ML ( 125 MGML )2222017 125422 038 1
ApplicantLicense No UCB INC 1736
Trade Name CIMZIA
Proper Name CERTOLIZUMAB PEGOL
BLASTN Approval Date PotencyDosage FormRoutePresentation Product
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
200 MG ( 200 MGVIAL ) 4222008 125160 0 1
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )5132009 125160 080 2
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
Trade Name CRYSVITA
Proper Name BUROSUMAB-TWZA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761068 0 1 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
10 MGML ( 10 MGML )
761068 0 2 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
20 MGML ( 20 MGML )
761068 0
Trade Name
Proper Name
BLASTN
March 2018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML ) 4172018 3
MEPSEVII
VESTRONIDASE ALFA-VJBK
Approval Date PotencyDosage FormRoutePresentation Product
Page 40 of 42
CDER Billable Biologic Product List
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
761047 0 1 11152017 10 MG5 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No UNITED THERAPEUTICS CORP 1993
Trade Name UNITUXIN
Proper Name DINUTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125516 0 1 3102015 175 MG5 ML ( 35 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053
Trade Name SILIQ
Proper Name BRODALUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761032 0 1 2152017 210 MG15 ML ( 140 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 41 of 42
CDER Billable Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No WYETH PHARMACEUTICALS INC 0003
Trade Name BESPONSA
Proper Name INOTUZUMAB OZOGAMICIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761040 0 1 8172017 09 MG ( 09 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 42 of 42
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 1 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
9172001 103951 0 26
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
200 MCGML ( 200 MCGML ) 09272012
103951 0 27 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
200 MCG04 ML ( 500 MCGML ) 09272012
103951 0 28 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
300 MCGML ( 300 MCGML ) 09272012
103951 0 29 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
300 MCG06 ML ( 500 MCGML ) 09272012
103951 0 30 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
500 MCGML ( 500 MCGML ) 09272012
ApplicantLicense No ASTELLAS PHARMACEUTICALS US INC 1748
Trade Name AMEVIVE
Proper Name ALEFACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125036 0 1 1302003 75 MGVIAL ( 75 MGVIAL ) 09242008
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
125036 0 2 1302003 15 MGVIAL ( 15 MGVIAL ) 09282012
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No BOEHRINGER INGELHEIM PHARMA KG 1251
Trade Name VERLUMA
Proper Name NOFETUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103769 0 1 10131998 10 MGML ( 10 MGML ) 08132013
INTRAVENOUS
March 2018 Page 2 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No CENTOCOR ORTHO BIOTECH PRODUCTS LP 1824
Trade Name ORTHOCLONE OKT3
Proper Name MUROMONAB-CD3
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103463 0 1 9141992 1 MGML ( 1 MGML ) 01112012
SOLUTION INTRAVENOUS AMPULE
ApplicantLicense No EISAI INCORPORATED 1862
Trade Name ONTAK
Proper Name DENILEUKIN DIFTITOX
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103767 0 1 251999 300 MCG2 ML ( 150 MCGML ) 01302014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No ELI LILLY AND CO 1611
Trade Name XIGRIS
Proper Name DROTRECOGIN ALFA (ACTIVATED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125029 0 1 11212001 5 MGVIAL ( 5 MGVIAL ) 10262011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125029 0 2 11212001 20 MGVIAL ( 20 MGVIAL ) 10102011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GENENTECH INC 1048
Trade Name RAPTIVA
Proper Name EFALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125075 0 1 10272003 125 MGVIAL ( 125 MGVIAL ) 09012009
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
March 2018 Page 3 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103976 0 2 6202003 125 MGVIAL ( 125 MGVIAL ) 08252016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103948 0 3 572001 10 MGVIAL ( 10 MGVIAL ) 07062011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name MYOZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125141 0 1 4282006 50 MGVIAL ( 50 MGVIAL ) 10172014
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name BEXXAR THERAPEUTIC REGIME
Proper Name TOSITUMOMAB AND IODINE I-131 TOSITUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125011 0 1 6272003 01 MGML I-131 TOSITUMOMAB ( 01 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 2 6272003 11 MGML I-131 TOSITUMOMAB ( 11 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 3 6272003 14 MGML TOSITUMOMAB ( 14 MGML 03102014 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 4 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No HEMISPHERX BIOPHARMA INC 1703
Trade Name ALFERON N INJECTION
Proper Name INTERFERON ALFA-N3 (HUMAN LEUKOCYTE DERIVED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103158 0 1 10101989 5 MIUVIAL ( 5 MIUVIAL ) 06272013
SOLUTION INTRALESIONAL MULTI-DOSE VIAL
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name ROFERON A
Proper Name INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103145 0 1 641986 3 MIU05 ML ( 3 MIU05 ML ) 06012009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name ZENAPAX
Proper Name DACLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103749 0 1 12101997 25 MG5 ML ( 25 MG5 ML ) 07072011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No KADMON PHARMACEUTICALS LLC 1867
Trade Name INFERGEN
Proper Name INTERFERON ALFACON-1
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103663 0 1 1061997 9 MCG03 ML ( 30 MCGML ) 07252013
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 5 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103770 0 3 6191998 50 MGVIAL ( 50 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
103770 0 4 6191998 100 MGVIAL ( 100 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name INTRON A
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103132 0 6 641986 10 MIUML ( 10 MIUML ) 09232013
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103132 0 7 641986 225 MIU15 ML ( 225 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 8 641986 375 MIU15 ML ( 375 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 9 641986 75 MIU15 ML ( 75 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103949 0 5 1192001 675 MCGPEN ( 675 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 6 1192001 108 MCGPEN ( 108 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
March 2018 Page 6 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name PEGINTRON
103949 0 7 1192001 1184 MCGVIAL ( 1184 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 8 1192001 162 MCGPEN ( 162 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 9 1192001 1776 MCGVIAL ( 1776 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 10 1192001 2025 MCGPEN ( 2025 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 11 1192001 222 MCGVIAL ( 222 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No PALATIN TECHNOLOGIES INC 1588
Trade Name NEUTROSPEC TECHNETIUM (99M TC)
Proper Name FANOLESOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103928 0 1 722004 025 MGVIAL ( 025 MGVIAL ) 09222008
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No RECORDATI RARE DISEASES INC 1899
Trade Name ELSPAR
Proper Name ASPARAGINASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
101063 0 1 1101978 10000 IU ( 10000 IUVIAL ) 04092014
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
March 2018 Page 7 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No SCHERING CORP 0994
Trade Name PEGINTRONREBETOL COMBO PACK
Proper Name PEGINTERFERON ALFA-2B AND RIBAVIRIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125196 0 1 6132008 ( 4 (120 MCG05ML) REDIPEN amp 140 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 2 6132008 ( 4 (150 MCG05ML) REDIPEN amp 168 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 3 6132008 ( 4 (150 MCG05ML) REDIPEN amp 196 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 4 6132008 ( 4 (50 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 5 6132008 ( 4 (80 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125422 0 2 10172012 05 MG ( 25 MGML ) 08082017
SOLUTION INTRAVETREAL SINGLE-DOSE VIAL
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125164 0 10 11142007 50 MCGML ( 50 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 8 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
125164 0 11 11142007 100 MCGML ( 100 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 12 11142007 200 MCGML ( 200 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 13 11142007 300 MCGML ( 300 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 14 11142007 400 MCGML ( 400 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 15 11142007 400 MCG06 ML ( 400 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 16 11142007 600 MCGML ( 600 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 17 11142007 600 MCG06 ML ( 600 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 18 11142007 800 MCG06 ML ( 800 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 19 11142007 1000 MCGML ( 1000 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 9 of 9
CDER Billable Biologic Product List
ApplicantLicense No SHIRE HUMAN GENETIC THERAPIES INC 1593
Trade Name ELAPRASE
Proper Name IDURSULFASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125151 0 1 7242006 6 MG3 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SICOR BIOTECH UAB 1803
Trade Name GRANIX
Proper Name TBO-FILGRASTIM
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125294 0 1 8292012
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
300 MCG0 5 ML ( 600 MCGML )
125294 0 2 8292012
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
480 MCG08 ML ( 600 MCGML )
ApplicantLicense No SMITH AND NEPHEW INC 2004
Trade Name REGRANEX
Proper Name BECAPLERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103691 0 1 12161997
GEL TOPICAL
100 UG ( 100 UGGM )
Trade Name
Proper Name
SANTYL
COLLAGENASE
BLASTN
101995 0
Product
1
Approval Date
641965
PotencyDosage FormRoutePresentation
OINTMENT TOPICAL
30 G amp 90 G TUBE ( 250 UGRAM )
March 2018 Page 37 of 42
CDER Billable Biologic Product List
ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718
Trade Name MYOBLOC
Proper Name RIMABOTULINUM TOXIN B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103846 0 1 1282002
SOLUTION INTRAMUSCULAR
2500 IU05 ML ( 5000 IUML )
SINGLE-DOSE VIAL
103846 0 3 1282002
SOLUTION INTRAMUSCULAR
10000 IU2 ML ( 5000 IUML )
SINGLE-DOSE VIAL
Proper Name RIMABOTULINUMTOXINB
BLASTN
103846 0
Product
2
Approval Date
1282002
PotencyDosage FormRoutePresentation
SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL
5000 IUML ( 5000 IUML )
ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832
Trade Name ZEVALIN
Proper Name IBRITUMOMAB TIUXETAN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125019 0 1 2192002 32 MG2 ML ( 16 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
Trade Name KEPIVANCE
Proper Name PALIFERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125103 0 1 12152004 625 MG ( 625 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name KINERET
Proper Name ANAKINRA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 38 of 42
CDER Billable Biologic Product List
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898
Trade Name ENTYVIO
Proper Name VEDOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125476 0 1 5202014 300 MG ( 300 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No TEVA RESPIRATORY LLC 2047
Trade Name CINQAIR
Proper Name RESLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761033 0 1 3232016 100 MG10 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No THERATECHNOLOGIES INC 2091
Trade Name TROGARZO
Proper Name IBALIZUMAB-UIYK
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761065 0 1 362018 200 MG133 ML ( 150 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 39 of 42
CDER Billable Biologic Product List
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
0375 MG03 ML ( 125 MGML )2222017 125422 038 1
ApplicantLicense No UCB INC 1736
Trade Name CIMZIA
Proper Name CERTOLIZUMAB PEGOL
BLASTN Approval Date PotencyDosage FormRoutePresentation Product
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
200 MG ( 200 MGVIAL ) 4222008 125160 0 1
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )5132009 125160 080 2
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
Trade Name CRYSVITA
Proper Name BUROSUMAB-TWZA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761068 0 1 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
10 MGML ( 10 MGML )
761068 0 2 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
20 MGML ( 20 MGML )
761068 0
Trade Name
Proper Name
BLASTN
March 2018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML ) 4172018 3
MEPSEVII
VESTRONIDASE ALFA-VJBK
Approval Date PotencyDosage FormRoutePresentation Product
Page 40 of 42
CDER Billable Biologic Product List
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
761047 0 1 11152017 10 MG5 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No UNITED THERAPEUTICS CORP 1993
Trade Name UNITUXIN
Proper Name DINUTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125516 0 1 3102015 175 MG5 ML ( 35 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053
Trade Name SILIQ
Proper Name BRODALUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761032 0 1 2152017 210 MG15 ML ( 140 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 41 of 42
CDER Billable Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No WYETH PHARMACEUTICALS INC 0003
Trade Name BESPONSA
Proper Name INOTUZUMAB OZOGAMICIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761040 0 1 8172017 09 MG ( 09 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 42 of 42
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 1 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
9172001 103951 0 26
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
200 MCGML ( 200 MCGML ) 09272012
103951 0 27 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
200 MCG04 ML ( 500 MCGML ) 09272012
103951 0 28 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
300 MCGML ( 300 MCGML ) 09272012
103951 0 29 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
300 MCG06 ML ( 500 MCGML ) 09272012
103951 0 30 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
500 MCGML ( 500 MCGML ) 09272012
ApplicantLicense No ASTELLAS PHARMACEUTICALS US INC 1748
Trade Name AMEVIVE
Proper Name ALEFACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125036 0 1 1302003 75 MGVIAL ( 75 MGVIAL ) 09242008
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
125036 0 2 1302003 15 MGVIAL ( 15 MGVIAL ) 09282012
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No BOEHRINGER INGELHEIM PHARMA KG 1251
Trade Name VERLUMA
Proper Name NOFETUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103769 0 1 10131998 10 MGML ( 10 MGML ) 08132013
INTRAVENOUS
March 2018 Page 2 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No CENTOCOR ORTHO BIOTECH PRODUCTS LP 1824
Trade Name ORTHOCLONE OKT3
Proper Name MUROMONAB-CD3
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103463 0 1 9141992 1 MGML ( 1 MGML ) 01112012
SOLUTION INTRAVENOUS AMPULE
ApplicantLicense No EISAI INCORPORATED 1862
Trade Name ONTAK
Proper Name DENILEUKIN DIFTITOX
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103767 0 1 251999 300 MCG2 ML ( 150 MCGML ) 01302014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No ELI LILLY AND CO 1611
Trade Name XIGRIS
Proper Name DROTRECOGIN ALFA (ACTIVATED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125029 0 1 11212001 5 MGVIAL ( 5 MGVIAL ) 10262011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125029 0 2 11212001 20 MGVIAL ( 20 MGVIAL ) 10102011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GENENTECH INC 1048
Trade Name RAPTIVA
Proper Name EFALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125075 0 1 10272003 125 MGVIAL ( 125 MGVIAL ) 09012009
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
March 2018 Page 3 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103976 0 2 6202003 125 MGVIAL ( 125 MGVIAL ) 08252016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103948 0 3 572001 10 MGVIAL ( 10 MGVIAL ) 07062011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name MYOZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125141 0 1 4282006 50 MGVIAL ( 50 MGVIAL ) 10172014
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name BEXXAR THERAPEUTIC REGIME
Proper Name TOSITUMOMAB AND IODINE I-131 TOSITUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125011 0 1 6272003 01 MGML I-131 TOSITUMOMAB ( 01 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 2 6272003 11 MGML I-131 TOSITUMOMAB ( 11 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 3 6272003 14 MGML TOSITUMOMAB ( 14 MGML 03102014 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 4 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No HEMISPHERX BIOPHARMA INC 1703
Trade Name ALFERON N INJECTION
Proper Name INTERFERON ALFA-N3 (HUMAN LEUKOCYTE DERIVED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103158 0 1 10101989 5 MIUVIAL ( 5 MIUVIAL ) 06272013
SOLUTION INTRALESIONAL MULTI-DOSE VIAL
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name ROFERON A
Proper Name INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103145 0 1 641986 3 MIU05 ML ( 3 MIU05 ML ) 06012009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name ZENAPAX
Proper Name DACLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103749 0 1 12101997 25 MG5 ML ( 25 MG5 ML ) 07072011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No KADMON PHARMACEUTICALS LLC 1867
Trade Name INFERGEN
Proper Name INTERFERON ALFACON-1
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103663 0 1 1061997 9 MCG03 ML ( 30 MCGML ) 07252013
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 5 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103770 0 3 6191998 50 MGVIAL ( 50 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
103770 0 4 6191998 100 MGVIAL ( 100 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name INTRON A
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103132 0 6 641986 10 MIUML ( 10 MIUML ) 09232013
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103132 0 7 641986 225 MIU15 ML ( 225 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 8 641986 375 MIU15 ML ( 375 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 9 641986 75 MIU15 ML ( 75 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103949 0 5 1192001 675 MCGPEN ( 675 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 6 1192001 108 MCGPEN ( 108 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
March 2018 Page 6 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name PEGINTRON
103949 0 7 1192001 1184 MCGVIAL ( 1184 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 8 1192001 162 MCGPEN ( 162 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 9 1192001 1776 MCGVIAL ( 1776 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 10 1192001 2025 MCGPEN ( 2025 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 11 1192001 222 MCGVIAL ( 222 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No PALATIN TECHNOLOGIES INC 1588
Trade Name NEUTROSPEC TECHNETIUM (99M TC)
Proper Name FANOLESOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103928 0 1 722004 025 MGVIAL ( 025 MGVIAL ) 09222008
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No RECORDATI RARE DISEASES INC 1899
Trade Name ELSPAR
Proper Name ASPARAGINASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
101063 0 1 1101978 10000 IU ( 10000 IUVIAL ) 04092014
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
March 2018 Page 7 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No SCHERING CORP 0994
Trade Name PEGINTRONREBETOL COMBO PACK
Proper Name PEGINTERFERON ALFA-2B AND RIBAVIRIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125196 0 1 6132008 ( 4 (120 MCG05ML) REDIPEN amp 140 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 2 6132008 ( 4 (150 MCG05ML) REDIPEN amp 168 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 3 6132008 ( 4 (150 MCG05ML) REDIPEN amp 196 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 4 6132008 ( 4 (50 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 5 6132008 ( 4 (80 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125422 0 2 10172012 05 MG ( 25 MGML ) 08082017
SOLUTION INTRAVETREAL SINGLE-DOSE VIAL
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125164 0 10 11142007 50 MCGML ( 50 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 8 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
125164 0 11 11142007 100 MCGML ( 100 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 12 11142007 200 MCGML ( 200 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 13 11142007 300 MCGML ( 300 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 14 11142007 400 MCGML ( 400 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 15 11142007 400 MCG06 ML ( 400 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 16 11142007 600 MCGML ( 600 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 17 11142007 600 MCG06 ML ( 600 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 18 11142007 800 MCG06 ML ( 800 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 19 11142007 1000 MCGML ( 1000 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 9 of 9
CDER Billable Biologic Product List
ApplicantLicense No SOLSTICE NEUROSCIENCES LLC 1718
Trade Name MYOBLOC
Proper Name RIMABOTULINUM TOXIN B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
103846 0 1 1282002
SOLUTION INTRAMUSCULAR
2500 IU05 ML ( 5000 IUML )
SINGLE-DOSE VIAL
103846 0 3 1282002
SOLUTION INTRAMUSCULAR
10000 IU2 ML ( 5000 IUML )
SINGLE-DOSE VIAL
Proper Name RIMABOTULINUMTOXINB
BLASTN
103846 0
Product
2
Approval Date
1282002
PotencyDosage FormRoutePresentation
SOLUTION INTRAMUSCULAR SINGLE-DOSE VIAL
5000 IUML ( 5000 IUML )
ApplicantLicense No SPECTRUM PHARMACEUTICALS INC 1832
Trade Name ZEVALIN
Proper Name IBRITUMOMAB TIUXETAN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125019 0 1 2192002 32 MG2 ML ( 16 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
Trade Name KEPIVANCE
Proper Name PALIFERMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125103 0 1 12152004 625 MG ( 625 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
Trade Name KINERET
Proper Name ANAKINRA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
March 2018 Page 38 of 42
CDER Billable Biologic Product List
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898
Trade Name ENTYVIO
Proper Name VEDOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125476 0 1 5202014 300 MG ( 300 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No TEVA RESPIRATORY LLC 2047
Trade Name CINQAIR
Proper Name RESLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761033 0 1 3232016 100 MG10 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No THERATECHNOLOGIES INC 2091
Trade Name TROGARZO
Proper Name IBALIZUMAB-UIYK
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761065 0 1 362018 200 MG133 ML ( 150 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 39 of 42
CDER Billable Biologic Product List
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
0375 MG03 ML ( 125 MGML )2222017 125422 038 1
ApplicantLicense No UCB INC 1736
Trade Name CIMZIA
Proper Name CERTOLIZUMAB PEGOL
BLASTN Approval Date PotencyDosage FormRoutePresentation Product
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
200 MG ( 200 MGVIAL ) 4222008 125160 0 1
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )5132009 125160 080 2
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
Trade Name CRYSVITA
Proper Name BUROSUMAB-TWZA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761068 0 1 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
10 MGML ( 10 MGML )
761068 0 2 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
20 MGML ( 20 MGML )
761068 0
Trade Name
Proper Name
BLASTN
March 2018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML ) 4172018 3
MEPSEVII
VESTRONIDASE ALFA-VJBK
Approval Date PotencyDosage FormRoutePresentation Product
Page 40 of 42
CDER Billable Biologic Product List
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
761047 0 1 11152017 10 MG5 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No UNITED THERAPEUTICS CORP 1993
Trade Name UNITUXIN
Proper Name DINUTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125516 0 1 3102015 175 MG5 ML ( 35 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053
Trade Name SILIQ
Proper Name BRODALUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761032 0 1 2152017 210 MG15 ML ( 140 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 41 of 42
CDER Billable Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No WYETH PHARMACEUTICALS INC 0003
Trade Name BESPONSA
Proper Name INOTUZUMAB OZOGAMICIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761040 0 1 8172017 09 MG ( 09 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 42 of 42
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 1 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
9172001 103951 0 26
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
200 MCGML ( 200 MCGML ) 09272012
103951 0 27 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
200 MCG04 ML ( 500 MCGML ) 09272012
103951 0 28 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
300 MCGML ( 300 MCGML ) 09272012
103951 0 29 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
300 MCG06 ML ( 500 MCGML ) 09272012
103951 0 30 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
500 MCGML ( 500 MCGML ) 09272012
ApplicantLicense No ASTELLAS PHARMACEUTICALS US INC 1748
Trade Name AMEVIVE
Proper Name ALEFACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125036 0 1 1302003 75 MGVIAL ( 75 MGVIAL ) 09242008
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
125036 0 2 1302003 15 MGVIAL ( 15 MGVIAL ) 09282012
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No BOEHRINGER INGELHEIM PHARMA KG 1251
Trade Name VERLUMA
Proper Name NOFETUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103769 0 1 10131998 10 MGML ( 10 MGML ) 08132013
INTRAVENOUS
March 2018 Page 2 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No CENTOCOR ORTHO BIOTECH PRODUCTS LP 1824
Trade Name ORTHOCLONE OKT3
Proper Name MUROMONAB-CD3
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103463 0 1 9141992 1 MGML ( 1 MGML ) 01112012
SOLUTION INTRAVENOUS AMPULE
ApplicantLicense No EISAI INCORPORATED 1862
Trade Name ONTAK
Proper Name DENILEUKIN DIFTITOX
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103767 0 1 251999 300 MCG2 ML ( 150 MCGML ) 01302014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No ELI LILLY AND CO 1611
Trade Name XIGRIS
Proper Name DROTRECOGIN ALFA (ACTIVATED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125029 0 1 11212001 5 MGVIAL ( 5 MGVIAL ) 10262011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125029 0 2 11212001 20 MGVIAL ( 20 MGVIAL ) 10102011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GENENTECH INC 1048
Trade Name RAPTIVA
Proper Name EFALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125075 0 1 10272003 125 MGVIAL ( 125 MGVIAL ) 09012009
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
March 2018 Page 3 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103976 0 2 6202003 125 MGVIAL ( 125 MGVIAL ) 08252016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103948 0 3 572001 10 MGVIAL ( 10 MGVIAL ) 07062011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name MYOZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125141 0 1 4282006 50 MGVIAL ( 50 MGVIAL ) 10172014
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name BEXXAR THERAPEUTIC REGIME
Proper Name TOSITUMOMAB AND IODINE I-131 TOSITUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125011 0 1 6272003 01 MGML I-131 TOSITUMOMAB ( 01 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 2 6272003 11 MGML I-131 TOSITUMOMAB ( 11 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 3 6272003 14 MGML TOSITUMOMAB ( 14 MGML 03102014 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 4 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No HEMISPHERX BIOPHARMA INC 1703
Trade Name ALFERON N INJECTION
Proper Name INTERFERON ALFA-N3 (HUMAN LEUKOCYTE DERIVED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103158 0 1 10101989 5 MIUVIAL ( 5 MIUVIAL ) 06272013
SOLUTION INTRALESIONAL MULTI-DOSE VIAL
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name ROFERON A
Proper Name INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103145 0 1 641986 3 MIU05 ML ( 3 MIU05 ML ) 06012009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name ZENAPAX
Proper Name DACLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103749 0 1 12101997 25 MG5 ML ( 25 MG5 ML ) 07072011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No KADMON PHARMACEUTICALS LLC 1867
Trade Name INFERGEN
Proper Name INTERFERON ALFACON-1
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103663 0 1 1061997 9 MCG03 ML ( 30 MCGML ) 07252013
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 5 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103770 0 3 6191998 50 MGVIAL ( 50 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
103770 0 4 6191998 100 MGVIAL ( 100 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name INTRON A
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103132 0 6 641986 10 MIUML ( 10 MIUML ) 09232013
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103132 0 7 641986 225 MIU15 ML ( 225 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 8 641986 375 MIU15 ML ( 375 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 9 641986 75 MIU15 ML ( 75 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103949 0 5 1192001 675 MCGPEN ( 675 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 6 1192001 108 MCGPEN ( 108 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
March 2018 Page 6 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name PEGINTRON
103949 0 7 1192001 1184 MCGVIAL ( 1184 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 8 1192001 162 MCGPEN ( 162 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 9 1192001 1776 MCGVIAL ( 1776 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 10 1192001 2025 MCGPEN ( 2025 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 11 1192001 222 MCGVIAL ( 222 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No PALATIN TECHNOLOGIES INC 1588
Trade Name NEUTROSPEC TECHNETIUM (99M TC)
Proper Name FANOLESOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103928 0 1 722004 025 MGVIAL ( 025 MGVIAL ) 09222008
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No RECORDATI RARE DISEASES INC 1899
Trade Name ELSPAR
Proper Name ASPARAGINASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
101063 0 1 1101978 10000 IU ( 10000 IUVIAL ) 04092014
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
March 2018 Page 7 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No SCHERING CORP 0994
Trade Name PEGINTRONREBETOL COMBO PACK
Proper Name PEGINTERFERON ALFA-2B AND RIBAVIRIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125196 0 1 6132008 ( 4 (120 MCG05ML) REDIPEN amp 140 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 2 6132008 ( 4 (150 MCG05ML) REDIPEN amp 168 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 3 6132008 ( 4 (150 MCG05ML) REDIPEN amp 196 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 4 6132008 ( 4 (50 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 5 6132008 ( 4 (80 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125422 0 2 10172012 05 MG ( 25 MGML ) 08082017
SOLUTION INTRAVETREAL SINGLE-DOSE VIAL
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125164 0 10 11142007 50 MCGML ( 50 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 8 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
125164 0 11 11142007 100 MCGML ( 100 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 12 11142007 200 MCGML ( 200 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 13 11142007 300 MCGML ( 300 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 14 11142007 400 MCGML ( 400 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 15 11142007 400 MCG06 ML ( 400 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 16 11142007 600 MCGML ( 600 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 17 11142007 600 MCG06 ML ( 600 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 18 11142007 800 MCG06 ML ( 800 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 19 11142007 1000 MCGML ( 1000 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 9 of 9
CDER Billable Biologic Product List
ApplicantLicense No SWEDISH ORPHAN BIOVITRUM AB 1828
103950 0 1 11142001 100 MG067 ML ( 100 MG067 ML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No TAKEDA PHARMACEUTICALS USA INC 1898
Trade Name ENTYVIO
Proper Name VEDOLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125476 0 1 5202014 300 MG ( 300 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No TEVA RESPIRATORY LLC 2047
Trade Name CINQAIR
Proper Name RESLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761033 0 1 3232016 100 MG10 ML ( 10 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No THERATECHNOLOGIES INC 2091
Trade Name TROGARZO
Proper Name IBALIZUMAB-UIYK
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761065 0 1 362018 200 MG133 ML ( 150 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 39 of 42
CDER Billable Biologic Product List
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
0375 MG03 ML ( 125 MGML )2222017 125422 038 1
ApplicantLicense No UCB INC 1736
Trade Name CIMZIA
Proper Name CERTOLIZUMAB PEGOL
BLASTN Approval Date PotencyDosage FormRoutePresentation Product
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
200 MG ( 200 MGVIAL ) 4222008 125160 0 1
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )5132009 125160 080 2
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
Trade Name CRYSVITA
Proper Name BUROSUMAB-TWZA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761068 0 1 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
10 MGML ( 10 MGML )
761068 0 2 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
20 MGML ( 20 MGML )
761068 0
Trade Name
Proper Name
BLASTN
March 2018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML ) 4172018 3
MEPSEVII
VESTRONIDASE ALFA-VJBK
Approval Date PotencyDosage FormRoutePresentation Product
Page 40 of 42
CDER Billable Biologic Product List
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
761047 0 1 11152017 10 MG5 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No UNITED THERAPEUTICS CORP 1993
Trade Name UNITUXIN
Proper Name DINUTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125516 0 1 3102015 175 MG5 ML ( 35 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053
Trade Name SILIQ
Proper Name BRODALUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761032 0 1 2152017 210 MG15 ML ( 140 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 41 of 42
CDER Billable Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No WYETH PHARMACEUTICALS INC 0003
Trade Name BESPONSA
Proper Name INOTUZUMAB OZOGAMICIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761040 0 1 8172017 09 MG ( 09 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 42 of 42
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 1 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
9172001 103951 0 26
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
200 MCGML ( 200 MCGML ) 09272012
103951 0 27 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
200 MCG04 ML ( 500 MCGML ) 09272012
103951 0 28 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
300 MCGML ( 300 MCGML ) 09272012
103951 0 29 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
300 MCG06 ML ( 500 MCGML ) 09272012
103951 0 30 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
500 MCGML ( 500 MCGML ) 09272012
ApplicantLicense No ASTELLAS PHARMACEUTICALS US INC 1748
Trade Name AMEVIVE
Proper Name ALEFACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125036 0 1 1302003 75 MGVIAL ( 75 MGVIAL ) 09242008
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
125036 0 2 1302003 15 MGVIAL ( 15 MGVIAL ) 09282012
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No BOEHRINGER INGELHEIM PHARMA KG 1251
Trade Name VERLUMA
Proper Name NOFETUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103769 0 1 10131998 10 MGML ( 10 MGML ) 08132013
INTRAVENOUS
March 2018 Page 2 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No CENTOCOR ORTHO BIOTECH PRODUCTS LP 1824
Trade Name ORTHOCLONE OKT3
Proper Name MUROMONAB-CD3
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103463 0 1 9141992 1 MGML ( 1 MGML ) 01112012
SOLUTION INTRAVENOUS AMPULE
ApplicantLicense No EISAI INCORPORATED 1862
Trade Name ONTAK
Proper Name DENILEUKIN DIFTITOX
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103767 0 1 251999 300 MCG2 ML ( 150 MCGML ) 01302014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No ELI LILLY AND CO 1611
Trade Name XIGRIS
Proper Name DROTRECOGIN ALFA (ACTIVATED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125029 0 1 11212001 5 MGVIAL ( 5 MGVIAL ) 10262011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125029 0 2 11212001 20 MGVIAL ( 20 MGVIAL ) 10102011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GENENTECH INC 1048
Trade Name RAPTIVA
Proper Name EFALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125075 0 1 10272003 125 MGVIAL ( 125 MGVIAL ) 09012009
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
March 2018 Page 3 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103976 0 2 6202003 125 MGVIAL ( 125 MGVIAL ) 08252016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103948 0 3 572001 10 MGVIAL ( 10 MGVIAL ) 07062011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name MYOZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125141 0 1 4282006 50 MGVIAL ( 50 MGVIAL ) 10172014
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name BEXXAR THERAPEUTIC REGIME
Proper Name TOSITUMOMAB AND IODINE I-131 TOSITUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125011 0 1 6272003 01 MGML I-131 TOSITUMOMAB ( 01 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 2 6272003 11 MGML I-131 TOSITUMOMAB ( 11 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 3 6272003 14 MGML TOSITUMOMAB ( 14 MGML 03102014 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 4 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No HEMISPHERX BIOPHARMA INC 1703
Trade Name ALFERON N INJECTION
Proper Name INTERFERON ALFA-N3 (HUMAN LEUKOCYTE DERIVED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103158 0 1 10101989 5 MIUVIAL ( 5 MIUVIAL ) 06272013
SOLUTION INTRALESIONAL MULTI-DOSE VIAL
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name ROFERON A
Proper Name INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103145 0 1 641986 3 MIU05 ML ( 3 MIU05 ML ) 06012009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name ZENAPAX
Proper Name DACLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103749 0 1 12101997 25 MG5 ML ( 25 MG5 ML ) 07072011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No KADMON PHARMACEUTICALS LLC 1867
Trade Name INFERGEN
Proper Name INTERFERON ALFACON-1
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103663 0 1 1061997 9 MCG03 ML ( 30 MCGML ) 07252013
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 5 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103770 0 3 6191998 50 MGVIAL ( 50 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
103770 0 4 6191998 100 MGVIAL ( 100 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name INTRON A
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103132 0 6 641986 10 MIUML ( 10 MIUML ) 09232013
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103132 0 7 641986 225 MIU15 ML ( 225 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 8 641986 375 MIU15 ML ( 375 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 9 641986 75 MIU15 ML ( 75 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103949 0 5 1192001 675 MCGPEN ( 675 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 6 1192001 108 MCGPEN ( 108 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
March 2018 Page 6 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name PEGINTRON
103949 0 7 1192001 1184 MCGVIAL ( 1184 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 8 1192001 162 MCGPEN ( 162 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 9 1192001 1776 MCGVIAL ( 1776 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 10 1192001 2025 MCGPEN ( 2025 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 11 1192001 222 MCGVIAL ( 222 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No PALATIN TECHNOLOGIES INC 1588
Trade Name NEUTROSPEC TECHNETIUM (99M TC)
Proper Name FANOLESOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103928 0 1 722004 025 MGVIAL ( 025 MGVIAL ) 09222008
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No RECORDATI RARE DISEASES INC 1899
Trade Name ELSPAR
Proper Name ASPARAGINASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
101063 0 1 1101978 10000 IU ( 10000 IUVIAL ) 04092014
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
March 2018 Page 7 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No SCHERING CORP 0994
Trade Name PEGINTRONREBETOL COMBO PACK
Proper Name PEGINTERFERON ALFA-2B AND RIBAVIRIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125196 0 1 6132008 ( 4 (120 MCG05ML) REDIPEN amp 140 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 2 6132008 ( 4 (150 MCG05ML) REDIPEN amp 168 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 3 6132008 ( 4 (150 MCG05ML) REDIPEN amp 196 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 4 6132008 ( 4 (50 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 5 6132008 ( 4 (80 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125422 0 2 10172012 05 MG ( 25 MGML ) 08082017
SOLUTION INTRAVETREAL SINGLE-DOSE VIAL
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125164 0 10 11142007 50 MCGML ( 50 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 8 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
125164 0 11 11142007 100 MCGML ( 100 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 12 11142007 200 MCGML ( 200 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 13 11142007 300 MCGML ( 300 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 14 11142007 400 MCGML ( 400 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 15 11142007 400 MCG06 ML ( 400 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 16 11142007 600 MCGML ( 600 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 17 11142007 600 MCG06 ML ( 600 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 18 11142007 800 MCG06 ML ( 800 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 19 11142007 1000 MCGML ( 1000 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 9 of 9
CDER Billable Biologic Product List
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
SOLUTION INTRAVITREAL SINGLE-DOSE VIAL
0375 MG03 ML ( 125 MGML )2222017 125422 038 1
ApplicantLicense No UCB INC 1736
Trade Name CIMZIA
Proper Name CERTOLIZUMAB PEGOL
BLASTN Approval Date PotencyDosage FormRoutePresentation Product
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
200 MG ( 200 MGVIAL ) 4222008 125160 0 1
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
200 MGML ( 200 MGML )5132009 125160 080 2
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
Trade Name CRYSVITA
Proper Name BUROSUMAB-TWZA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761068 0 1 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
10 MGML ( 10 MGML )
761068 0 2 4172018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
20 MGML ( 20 MGML )
761068 0
Trade Name
Proper Name
BLASTN
March 2018
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
30 MGML ( 30 MGML ) 4172018 3
MEPSEVII
VESTRONIDASE ALFA-VJBK
Approval Date PotencyDosage FormRoutePresentation Product
Page 40 of 42
CDER Billable Biologic Product List
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
761047 0 1 11152017 10 MG5 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No UNITED THERAPEUTICS CORP 1993
Trade Name UNITUXIN
Proper Name DINUTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125516 0 1 3102015 175 MG5 ML ( 35 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053
Trade Name SILIQ
Proper Name BRODALUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761032 0 1 2152017 210 MG15 ML ( 140 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 41 of 42
CDER Billable Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No WYETH PHARMACEUTICALS INC 0003
Trade Name BESPONSA
Proper Name INOTUZUMAB OZOGAMICIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761040 0 1 8172017 09 MG ( 09 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 42 of 42
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 1 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
9172001 103951 0 26
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
200 MCGML ( 200 MCGML ) 09272012
103951 0 27 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
200 MCG04 ML ( 500 MCGML ) 09272012
103951 0 28 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
300 MCGML ( 300 MCGML ) 09272012
103951 0 29 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
300 MCG06 ML ( 500 MCGML ) 09272012
103951 0 30 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
500 MCGML ( 500 MCGML ) 09272012
ApplicantLicense No ASTELLAS PHARMACEUTICALS US INC 1748
Trade Name AMEVIVE
Proper Name ALEFACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125036 0 1 1302003 75 MGVIAL ( 75 MGVIAL ) 09242008
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
125036 0 2 1302003 15 MGVIAL ( 15 MGVIAL ) 09282012
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No BOEHRINGER INGELHEIM PHARMA KG 1251
Trade Name VERLUMA
Proper Name NOFETUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103769 0 1 10131998 10 MGML ( 10 MGML ) 08132013
INTRAVENOUS
March 2018 Page 2 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No CENTOCOR ORTHO BIOTECH PRODUCTS LP 1824
Trade Name ORTHOCLONE OKT3
Proper Name MUROMONAB-CD3
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103463 0 1 9141992 1 MGML ( 1 MGML ) 01112012
SOLUTION INTRAVENOUS AMPULE
ApplicantLicense No EISAI INCORPORATED 1862
Trade Name ONTAK
Proper Name DENILEUKIN DIFTITOX
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103767 0 1 251999 300 MCG2 ML ( 150 MCGML ) 01302014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No ELI LILLY AND CO 1611
Trade Name XIGRIS
Proper Name DROTRECOGIN ALFA (ACTIVATED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125029 0 1 11212001 5 MGVIAL ( 5 MGVIAL ) 10262011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125029 0 2 11212001 20 MGVIAL ( 20 MGVIAL ) 10102011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GENENTECH INC 1048
Trade Name RAPTIVA
Proper Name EFALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125075 0 1 10272003 125 MGVIAL ( 125 MGVIAL ) 09012009
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
March 2018 Page 3 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103976 0 2 6202003 125 MGVIAL ( 125 MGVIAL ) 08252016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103948 0 3 572001 10 MGVIAL ( 10 MGVIAL ) 07062011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name MYOZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125141 0 1 4282006 50 MGVIAL ( 50 MGVIAL ) 10172014
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name BEXXAR THERAPEUTIC REGIME
Proper Name TOSITUMOMAB AND IODINE I-131 TOSITUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125011 0 1 6272003 01 MGML I-131 TOSITUMOMAB ( 01 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 2 6272003 11 MGML I-131 TOSITUMOMAB ( 11 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 3 6272003 14 MGML TOSITUMOMAB ( 14 MGML 03102014 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 4 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No HEMISPHERX BIOPHARMA INC 1703
Trade Name ALFERON N INJECTION
Proper Name INTERFERON ALFA-N3 (HUMAN LEUKOCYTE DERIVED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103158 0 1 10101989 5 MIUVIAL ( 5 MIUVIAL ) 06272013
SOLUTION INTRALESIONAL MULTI-DOSE VIAL
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name ROFERON A
Proper Name INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103145 0 1 641986 3 MIU05 ML ( 3 MIU05 ML ) 06012009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name ZENAPAX
Proper Name DACLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103749 0 1 12101997 25 MG5 ML ( 25 MG5 ML ) 07072011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No KADMON PHARMACEUTICALS LLC 1867
Trade Name INFERGEN
Proper Name INTERFERON ALFACON-1
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103663 0 1 1061997 9 MCG03 ML ( 30 MCGML ) 07252013
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 5 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103770 0 3 6191998 50 MGVIAL ( 50 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
103770 0 4 6191998 100 MGVIAL ( 100 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name INTRON A
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103132 0 6 641986 10 MIUML ( 10 MIUML ) 09232013
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103132 0 7 641986 225 MIU15 ML ( 225 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 8 641986 375 MIU15 ML ( 375 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 9 641986 75 MIU15 ML ( 75 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103949 0 5 1192001 675 MCGPEN ( 675 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 6 1192001 108 MCGPEN ( 108 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
March 2018 Page 6 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name PEGINTRON
103949 0 7 1192001 1184 MCGVIAL ( 1184 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 8 1192001 162 MCGPEN ( 162 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 9 1192001 1776 MCGVIAL ( 1776 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 10 1192001 2025 MCGPEN ( 2025 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 11 1192001 222 MCGVIAL ( 222 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No PALATIN TECHNOLOGIES INC 1588
Trade Name NEUTROSPEC TECHNETIUM (99M TC)
Proper Name FANOLESOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103928 0 1 722004 025 MGVIAL ( 025 MGVIAL ) 09222008
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No RECORDATI RARE DISEASES INC 1899
Trade Name ELSPAR
Proper Name ASPARAGINASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
101063 0 1 1101978 10000 IU ( 10000 IUVIAL ) 04092014
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
March 2018 Page 7 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No SCHERING CORP 0994
Trade Name PEGINTRONREBETOL COMBO PACK
Proper Name PEGINTERFERON ALFA-2B AND RIBAVIRIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125196 0 1 6132008 ( 4 (120 MCG05ML) REDIPEN amp 140 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 2 6132008 ( 4 (150 MCG05ML) REDIPEN amp 168 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 3 6132008 ( 4 (150 MCG05ML) REDIPEN amp 196 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 4 6132008 ( 4 (50 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 5 6132008 ( 4 (80 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125422 0 2 10172012 05 MG ( 25 MGML ) 08082017
SOLUTION INTRAVETREAL SINGLE-DOSE VIAL
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125164 0 10 11142007 50 MCGML ( 50 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 8 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
125164 0 11 11142007 100 MCGML ( 100 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 12 11142007 200 MCGML ( 200 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 13 11142007 300 MCGML ( 300 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 14 11142007 400 MCGML ( 400 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 15 11142007 400 MCG06 ML ( 400 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 16 11142007 600 MCGML ( 600 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 17 11142007 600 MCG06 ML ( 600 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 18 11142007 800 MCG06 ML ( 800 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 19 11142007 1000 MCGML ( 1000 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 9 of 9
CDER Billable Biologic Product List
ApplicantLicense No ULTRAGENYX PHARMACEUTICAL INC 2040
761047 0 1 11152017 10 MG5 ML ( 2 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No UNITED THERAPEUTICS CORP 1993
Trade Name UNITUXIN
Proper Name DINUTUXIMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125516 0 1 3102015 175 MG5 ML ( 35 MGML )
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No VALEANT PHARMACEUTICALS LUXEMBOURG SARL 2053
Trade Name SILIQ
Proper Name BRODALUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761032 0 1 2152017 210 MG15 ML ( 140 MGML )
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
125164 0 1 11142007 50 MCG03 ML ( 16666 MGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 2 11142007 75 MCG03 ML ( 250 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 3 11142007 100 MCG03 ML ( 33333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 41 of 42
CDER Billable Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No WYETH PHARMACEUTICALS INC 0003
Trade Name BESPONSA
Proper Name INOTUZUMAB OZOGAMICIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761040 0 1 8172017 09 MG ( 09 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 42 of 42
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 1 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
9172001 103951 0 26
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
200 MCGML ( 200 MCGML ) 09272012
103951 0 27 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
200 MCG04 ML ( 500 MCGML ) 09272012
103951 0 28 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
300 MCGML ( 300 MCGML ) 09272012
103951 0 29 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
300 MCG06 ML ( 500 MCGML ) 09272012
103951 0 30 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
500 MCGML ( 500 MCGML ) 09272012
ApplicantLicense No ASTELLAS PHARMACEUTICALS US INC 1748
Trade Name AMEVIVE
Proper Name ALEFACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125036 0 1 1302003 75 MGVIAL ( 75 MGVIAL ) 09242008
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
125036 0 2 1302003 15 MGVIAL ( 15 MGVIAL ) 09282012
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No BOEHRINGER INGELHEIM PHARMA KG 1251
Trade Name VERLUMA
Proper Name NOFETUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103769 0 1 10131998 10 MGML ( 10 MGML ) 08132013
INTRAVENOUS
March 2018 Page 2 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No CENTOCOR ORTHO BIOTECH PRODUCTS LP 1824
Trade Name ORTHOCLONE OKT3
Proper Name MUROMONAB-CD3
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103463 0 1 9141992 1 MGML ( 1 MGML ) 01112012
SOLUTION INTRAVENOUS AMPULE
ApplicantLicense No EISAI INCORPORATED 1862
Trade Name ONTAK
Proper Name DENILEUKIN DIFTITOX
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103767 0 1 251999 300 MCG2 ML ( 150 MCGML ) 01302014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No ELI LILLY AND CO 1611
Trade Name XIGRIS
Proper Name DROTRECOGIN ALFA (ACTIVATED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125029 0 1 11212001 5 MGVIAL ( 5 MGVIAL ) 10262011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125029 0 2 11212001 20 MGVIAL ( 20 MGVIAL ) 10102011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GENENTECH INC 1048
Trade Name RAPTIVA
Proper Name EFALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125075 0 1 10272003 125 MGVIAL ( 125 MGVIAL ) 09012009
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
March 2018 Page 3 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103976 0 2 6202003 125 MGVIAL ( 125 MGVIAL ) 08252016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103948 0 3 572001 10 MGVIAL ( 10 MGVIAL ) 07062011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name MYOZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125141 0 1 4282006 50 MGVIAL ( 50 MGVIAL ) 10172014
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name BEXXAR THERAPEUTIC REGIME
Proper Name TOSITUMOMAB AND IODINE I-131 TOSITUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125011 0 1 6272003 01 MGML I-131 TOSITUMOMAB ( 01 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 2 6272003 11 MGML I-131 TOSITUMOMAB ( 11 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 3 6272003 14 MGML TOSITUMOMAB ( 14 MGML 03102014 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 4 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No HEMISPHERX BIOPHARMA INC 1703
Trade Name ALFERON N INJECTION
Proper Name INTERFERON ALFA-N3 (HUMAN LEUKOCYTE DERIVED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103158 0 1 10101989 5 MIUVIAL ( 5 MIUVIAL ) 06272013
SOLUTION INTRALESIONAL MULTI-DOSE VIAL
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name ROFERON A
Proper Name INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103145 0 1 641986 3 MIU05 ML ( 3 MIU05 ML ) 06012009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name ZENAPAX
Proper Name DACLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103749 0 1 12101997 25 MG5 ML ( 25 MG5 ML ) 07072011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No KADMON PHARMACEUTICALS LLC 1867
Trade Name INFERGEN
Proper Name INTERFERON ALFACON-1
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103663 0 1 1061997 9 MCG03 ML ( 30 MCGML ) 07252013
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 5 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103770 0 3 6191998 50 MGVIAL ( 50 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
103770 0 4 6191998 100 MGVIAL ( 100 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name INTRON A
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103132 0 6 641986 10 MIUML ( 10 MIUML ) 09232013
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103132 0 7 641986 225 MIU15 ML ( 225 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 8 641986 375 MIU15 ML ( 375 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 9 641986 75 MIU15 ML ( 75 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103949 0 5 1192001 675 MCGPEN ( 675 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 6 1192001 108 MCGPEN ( 108 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
March 2018 Page 6 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name PEGINTRON
103949 0 7 1192001 1184 MCGVIAL ( 1184 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 8 1192001 162 MCGPEN ( 162 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 9 1192001 1776 MCGVIAL ( 1776 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 10 1192001 2025 MCGPEN ( 2025 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 11 1192001 222 MCGVIAL ( 222 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No PALATIN TECHNOLOGIES INC 1588
Trade Name NEUTROSPEC TECHNETIUM (99M TC)
Proper Name FANOLESOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103928 0 1 722004 025 MGVIAL ( 025 MGVIAL ) 09222008
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No RECORDATI RARE DISEASES INC 1899
Trade Name ELSPAR
Proper Name ASPARAGINASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
101063 0 1 1101978 10000 IU ( 10000 IUVIAL ) 04092014
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
March 2018 Page 7 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No SCHERING CORP 0994
Trade Name PEGINTRONREBETOL COMBO PACK
Proper Name PEGINTERFERON ALFA-2B AND RIBAVIRIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125196 0 1 6132008 ( 4 (120 MCG05ML) REDIPEN amp 140 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 2 6132008 ( 4 (150 MCG05ML) REDIPEN amp 168 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 3 6132008 ( 4 (150 MCG05ML) REDIPEN amp 196 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 4 6132008 ( 4 (50 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 5 6132008 ( 4 (80 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125422 0 2 10172012 05 MG ( 25 MGML ) 08082017
SOLUTION INTRAVETREAL SINGLE-DOSE VIAL
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125164 0 10 11142007 50 MCGML ( 50 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 8 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
125164 0 11 11142007 100 MCGML ( 100 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 12 11142007 200 MCGML ( 200 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 13 11142007 300 MCGML ( 300 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 14 11142007 400 MCGML ( 400 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 15 11142007 400 MCG06 ML ( 400 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 16 11142007 600 MCGML ( 600 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 17 11142007 600 MCG06 ML ( 600 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 18 11142007 800 MCG06 ML ( 800 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 19 11142007 1000 MCGML ( 1000 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 9 of 9
CDER Billable Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
125164 0 4 11142007 150 MCG03 ML ( 500 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 5 11142007 200 MCG03 ML ( 66666 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 6 11142007 250 MCG03 ML ( 83333 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 7 4282016 30 MCG03 ML ( 100 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 8 4282016 120 MCG03 ML ( 400 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 073 9 4282016 360 MCG06 ML ( 600 MCGML )
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
ApplicantLicense No WYETH PHARMACEUTICALS INC 0003
Trade Name BESPONSA
Proper Name INOTUZUMAB OZOGAMICIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation
761040 0 1 8172017 09 MG ( 09 MGVIAL )
POWDER INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 42 of 42
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 1 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
9172001 103951 0 26
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
200 MCGML ( 200 MCGML ) 09272012
103951 0 27 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
200 MCG04 ML ( 500 MCGML ) 09272012
103951 0 28 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
300 MCGML ( 300 MCGML ) 09272012
103951 0 29 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
300 MCG06 ML ( 500 MCGML ) 09272012
103951 0 30 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
500 MCGML ( 500 MCGML ) 09272012
ApplicantLicense No ASTELLAS PHARMACEUTICALS US INC 1748
Trade Name AMEVIVE
Proper Name ALEFACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125036 0 1 1302003 75 MGVIAL ( 75 MGVIAL ) 09242008
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
125036 0 2 1302003 15 MGVIAL ( 15 MGVIAL ) 09282012
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No BOEHRINGER INGELHEIM PHARMA KG 1251
Trade Name VERLUMA
Proper Name NOFETUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103769 0 1 10131998 10 MGML ( 10 MGML ) 08132013
INTRAVENOUS
March 2018 Page 2 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No CENTOCOR ORTHO BIOTECH PRODUCTS LP 1824
Trade Name ORTHOCLONE OKT3
Proper Name MUROMONAB-CD3
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103463 0 1 9141992 1 MGML ( 1 MGML ) 01112012
SOLUTION INTRAVENOUS AMPULE
ApplicantLicense No EISAI INCORPORATED 1862
Trade Name ONTAK
Proper Name DENILEUKIN DIFTITOX
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103767 0 1 251999 300 MCG2 ML ( 150 MCGML ) 01302014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No ELI LILLY AND CO 1611
Trade Name XIGRIS
Proper Name DROTRECOGIN ALFA (ACTIVATED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125029 0 1 11212001 5 MGVIAL ( 5 MGVIAL ) 10262011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125029 0 2 11212001 20 MGVIAL ( 20 MGVIAL ) 10102011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GENENTECH INC 1048
Trade Name RAPTIVA
Proper Name EFALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125075 0 1 10272003 125 MGVIAL ( 125 MGVIAL ) 09012009
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
March 2018 Page 3 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103976 0 2 6202003 125 MGVIAL ( 125 MGVIAL ) 08252016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103948 0 3 572001 10 MGVIAL ( 10 MGVIAL ) 07062011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name MYOZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125141 0 1 4282006 50 MGVIAL ( 50 MGVIAL ) 10172014
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name BEXXAR THERAPEUTIC REGIME
Proper Name TOSITUMOMAB AND IODINE I-131 TOSITUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125011 0 1 6272003 01 MGML I-131 TOSITUMOMAB ( 01 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 2 6272003 11 MGML I-131 TOSITUMOMAB ( 11 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 3 6272003 14 MGML TOSITUMOMAB ( 14 MGML 03102014 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 4 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No HEMISPHERX BIOPHARMA INC 1703
Trade Name ALFERON N INJECTION
Proper Name INTERFERON ALFA-N3 (HUMAN LEUKOCYTE DERIVED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103158 0 1 10101989 5 MIUVIAL ( 5 MIUVIAL ) 06272013
SOLUTION INTRALESIONAL MULTI-DOSE VIAL
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name ROFERON A
Proper Name INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103145 0 1 641986 3 MIU05 ML ( 3 MIU05 ML ) 06012009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name ZENAPAX
Proper Name DACLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103749 0 1 12101997 25 MG5 ML ( 25 MG5 ML ) 07072011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No KADMON PHARMACEUTICALS LLC 1867
Trade Name INFERGEN
Proper Name INTERFERON ALFACON-1
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103663 0 1 1061997 9 MCG03 ML ( 30 MCGML ) 07252013
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 5 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103770 0 3 6191998 50 MGVIAL ( 50 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
103770 0 4 6191998 100 MGVIAL ( 100 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name INTRON A
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103132 0 6 641986 10 MIUML ( 10 MIUML ) 09232013
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103132 0 7 641986 225 MIU15 ML ( 225 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 8 641986 375 MIU15 ML ( 375 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 9 641986 75 MIU15 ML ( 75 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103949 0 5 1192001 675 MCGPEN ( 675 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 6 1192001 108 MCGPEN ( 108 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
March 2018 Page 6 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name PEGINTRON
103949 0 7 1192001 1184 MCGVIAL ( 1184 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 8 1192001 162 MCGPEN ( 162 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 9 1192001 1776 MCGVIAL ( 1776 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 10 1192001 2025 MCGPEN ( 2025 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 11 1192001 222 MCGVIAL ( 222 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No PALATIN TECHNOLOGIES INC 1588
Trade Name NEUTROSPEC TECHNETIUM (99M TC)
Proper Name FANOLESOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103928 0 1 722004 025 MGVIAL ( 025 MGVIAL ) 09222008
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No RECORDATI RARE DISEASES INC 1899
Trade Name ELSPAR
Proper Name ASPARAGINASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
101063 0 1 1101978 10000 IU ( 10000 IUVIAL ) 04092014
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
March 2018 Page 7 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No SCHERING CORP 0994
Trade Name PEGINTRONREBETOL COMBO PACK
Proper Name PEGINTERFERON ALFA-2B AND RIBAVIRIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125196 0 1 6132008 ( 4 (120 MCG05ML) REDIPEN amp 140 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 2 6132008 ( 4 (150 MCG05ML) REDIPEN amp 168 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 3 6132008 ( 4 (150 MCG05ML) REDIPEN amp 196 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 4 6132008 ( 4 (50 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 5 6132008 ( 4 (80 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125422 0 2 10172012 05 MG ( 25 MGML ) 08082017
SOLUTION INTRAVETREAL SINGLE-DOSE VIAL
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125164 0 10 11142007 50 MCGML ( 50 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 8 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
125164 0 11 11142007 100 MCGML ( 100 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 12 11142007 200 MCGML ( 200 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 13 11142007 300 MCGML ( 300 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 14 11142007 400 MCGML ( 400 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 15 11142007 400 MCG06 ML ( 400 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 16 11142007 600 MCGML ( 600 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 17 11142007 600 MCG06 ML ( 600 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 18 11142007 800 MCG06 ML ( 800 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 19 11142007 1000 MCGML ( 1000 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 9 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
Proper Name DARBEPOETIN ALFA (ALBUMIN SOLUTION)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103951 0 16 9172001 25 MCGML ( 25 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 17 9172001 25 MCG042 ML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 18 9172001 40 MCGML ( 40 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 19 9172001 40 MCG04 ML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 20 9172001 60 MCGML ( 60 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 21 9172001 60 MCG03 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 22 9172001 100 MCGML ( 100 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 23 9172001 100 MCG05 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
103951 0 24 9172001 150 MCG075 ML ( 200 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103951 0 25 9172001 150 MCG03 ML ( 500 MCGML ) 09272012
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
March 2018 Page 1 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
9172001 103951 0 26
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
200 MCGML ( 200 MCGML ) 09272012
103951 0 27 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
200 MCG04 ML ( 500 MCGML ) 09272012
103951 0 28 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
300 MCGML ( 300 MCGML ) 09272012
103951 0 29 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
300 MCG06 ML ( 500 MCGML ) 09272012
103951 0 30 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
500 MCGML ( 500 MCGML ) 09272012
ApplicantLicense No ASTELLAS PHARMACEUTICALS US INC 1748
Trade Name AMEVIVE
Proper Name ALEFACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125036 0 1 1302003 75 MGVIAL ( 75 MGVIAL ) 09242008
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
125036 0 2 1302003 15 MGVIAL ( 15 MGVIAL ) 09282012
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No BOEHRINGER INGELHEIM PHARMA KG 1251
Trade Name VERLUMA
Proper Name NOFETUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103769 0 1 10131998 10 MGML ( 10 MGML ) 08132013
INTRAVENOUS
March 2018 Page 2 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No CENTOCOR ORTHO BIOTECH PRODUCTS LP 1824
Trade Name ORTHOCLONE OKT3
Proper Name MUROMONAB-CD3
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103463 0 1 9141992 1 MGML ( 1 MGML ) 01112012
SOLUTION INTRAVENOUS AMPULE
ApplicantLicense No EISAI INCORPORATED 1862
Trade Name ONTAK
Proper Name DENILEUKIN DIFTITOX
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103767 0 1 251999 300 MCG2 ML ( 150 MCGML ) 01302014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No ELI LILLY AND CO 1611
Trade Name XIGRIS
Proper Name DROTRECOGIN ALFA (ACTIVATED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125029 0 1 11212001 5 MGVIAL ( 5 MGVIAL ) 10262011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125029 0 2 11212001 20 MGVIAL ( 20 MGVIAL ) 10102011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GENENTECH INC 1048
Trade Name RAPTIVA
Proper Name EFALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125075 0 1 10272003 125 MGVIAL ( 125 MGVIAL ) 09012009
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
March 2018 Page 3 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103976 0 2 6202003 125 MGVIAL ( 125 MGVIAL ) 08252016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103948 0 3 572001 10 MGVIAL ( 10 MGVIAL ) 07062011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name MYOZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125141 0 1 4282006 50 MGVIAL ( 50 MGVIAL ) 10172014
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name BEXXAR THERAPEUTIC REGIME
Proper Name TOSITUMOMAB AND IODINE I-131 TOSITUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125011 0 1 6272003 01 MGML I-131 TOSITUMOMAB ( 01 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 2 6272003 11 MGML I-131 TOSITUMOMAB ( 11 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 3 6272003 14 MGML TOSITUMOMAB ( 14 MGML 03102014 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 4 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No HEMISPHERX BIOPHARMA INC 1703
Trade Name ALFERON N INJECTION
Proper Name INTERFERON ALFA-N3 (HUMAN LEUKOCYTE DERIVED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103158 0 1 10101989 5 MIUVIAL ( 5 MIUVIAL ) 06272013
SOLUTION INTRALESIONAL MULTI-DOSE VIAL
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name ROFERON A
Proper Name INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103145 0 1 641986 3 MIU05 ML ( 3 MIU05 ML ) 06012009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name ZENAPAX
Proper Name DACLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103749 0 1 12101997 25 MG5 ML ( 25 MG5 ML ) 07072011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No KADMON PHARMACEUTICALS LLC 1867
Trade Name INFERGEN
Proper Name INTERFERON ALFACON-1
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103663 0 1 1061997 9 MCG03 ML ( 30 MCGML ) 07252013
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 5 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103770 0 3 6191998 50 MGVIAL ( 50 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
103770 0 4 6191998 100 MGVIAL ( 100 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name INTRON A
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103132 0 6 641986 10 MIUML ( 10 MIUML ) 09232013
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103132 0 7 641986 225 MIU15 ML ( 225 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 8 641986 375 MIU15 ML ( 375 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 9 641986 75 MIU15 ML ( 75 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103949 0 5 1192001 675 MCGPEN ( 675 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 6 1192001 108 MCGPEN ( 108 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
March 2018 Page 6 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name PEGINTRON
103949 0 7 1192001 1184 MCGVIAL ( 1184 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 8 1192001 162 MCGPEN ( 162 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 9 1192001 1776 MCGVIAL ( 1776 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 10 1192001 2025 MCGPEN ( 2025 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 11 1192001 222 MCGVIAL ( 222 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No PALATIN TECHNOLOGIES INC 1588
Trade Name NEUTROSPEC TECHNETIUM (99M TC)
Proper Name FANOLESOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103928 0 1 722004 025 MGVIAL ( 025 MGVIAL ) 09222008
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No RECORDATI RARE DISEASES INC 1899
Trade Name ELSPAR
Proper Name ASPARAGINASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
101063 0 1 1101978 10000 IU ( 10000 IUVIAL ) 04092014
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
March 2018 Page 7 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No SCHERING CORP 0994
Trade Name PEGINTRONREBETOL COMBO PACK
Proper Name PEGINTERFERON ALFA-2B AND RIBAVIRIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125196 0 1 6132008 ( 4 (120 MCG05ML) REDIPEN amp 140 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 2 6132008 ( 4 (150 MCG05ML) REDIPEN amp 168 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 3 6132008 ( 4 (150 MCG05ML) REDIPEN amp 196 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 4 6132008 ( 4 (50 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 5 6132008 ( 4 (80 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125422 0 2 10172012 05 MG ( 25 MGML ) 08082017
SOLUTION INTRAVETREAL SINGLE-DOSE VIAL
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125164 0 10 11142007 50 MCGML ( 50 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 8 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
125164 0 11 11142007 100 MCGML ( 100 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 12 11142007 200 MCGML ( 200 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 13 11142007 300 MCGML ( 300 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 14 11142007 400 MCGML ( 400 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 15 11142007 400 MCG06 ML ( 400 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 16 11142007 600 MCGML ( 600 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 17 11142007 600 MCG06 ML ( 600 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 18 11142007 800 MCG06 ML ( 800 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 19 11142007 1000 MCGML ( 1000 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 9 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No AMGEN INC 1080
Trade Name ARANESP
9172001 103951 0 26
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
200 MCGML ( 200 MCGML ) 09272012
103951 0 27 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
200 MCG04 ML ( 500 MCGML ) 09272012
103951 0 28 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
300 MCGML ( 300 MCGML ) 09272012
103951 0 29 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
300 MCG06 ML ( 500 MCGML ) 09272012
103951 0 30 9172001
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
500 MCGML ( 500 MCGML ) 09272012
ApplicantLicense No ASTELLAS PHARMACEUTICALS US INC 1748
Trade Name AMEVIVE
Proper Name ALEFACEPT
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125036 0 1 1302003 75 MGVIAL ( 75 MGVIAL ) 09242008
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
125036 0 2 1302003 15 MGVIAL ( 15 MGVIAL ) 09282012
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No BOEHRINGER INGELHEIM PHARMA KG 1251
Trade Name VERLUMA
Proper Name NOFETUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103769 0 1 10131998 10 MGML ( 10 MGML ) 08132013
INTRAVENOUS
March 2018 Page 2 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No CENTOCOR ORTHO BIOTECH PRODUCTS LP 1824
Trade Name ORTHOCLONE OKT3
Proper Name MUROMONAB-CD3
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103463 0 1 9141992 1 MGML ( 1 MGML ) 01112012
SOLUTION INTRAVENOUS AMPULE
ApplicantLicense No EISAI INCORPORATED 1862
Trade Name ONTAK
Proper Name DENILEUKIN DIFTITOX
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103767 0 1 251999 300 MCG2 ML ( 150 MCGML ) 01302014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No ELI LILLY AND CO 1611
Trade Name XIGRIS
Proper Name DROTRECOGIN ALFA (ACTIVATED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125029 0 1 11212001 5 MGVIAL ( 5 MGVIAL ) 10262011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125029 0 2 11212001 20 MGVIAL ( 20 MGVIAL ) 10102011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GENENTECH INC 1048
Trade Name RAPTIVA
Proper Name EFALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125075 0 1 10272003 125 MGVIAL ( 125 MGVIAL ) 09012009
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
March 2018 Page 3 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103976 0 2 6202003 125 MGVIAL ( 125 MGVIAL ) 08252016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103948 0 3 572001 10 MGVIAL ( 10 MGVIAL ) 07062011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name MYOZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125141 0 1 4282006 50 MGVIAL ( 50 MGVIAL ) 10172014
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name BEXXAR THERAPEUTIC REGIME
Proper Name TOSITUMOMAB AND IODINE I-131 TOSITUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125011 0 1 6272003 01 MGML I-131 TOSITUMOMAB ( 01 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 2 6272003 11 MGML I-131 TOSITUMOMAB ( 11 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 3 6272003 14 MGML TOSITUMOMAB ( 14 MGML 03102014 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 4 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No HEMISPHERX BIOPHARMA INC 1703
Trade Name ALFERON N INJECTION
Proper Name INTERFERON ALFA-N3 (HUMAN LEUKOCYTE DERIVED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103158 0 1 10101989 5 MIUVIAL ( 5 MIUVIAL ) 06272013
SOLUTION INTRALESIONAL MULTI-DOSE VIAL
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name ROFERON A
Proper Name INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103145 0 1 641986 3 MIU05 ML ( 3 MIU05 ML ) 06012009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name ZENAPAX
Proper Name DACLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103749 0 1 12101997 25 MG5 ML ( 25 MG5 ML ) 07072011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No KADMON PHARMACEUTICALS LLC 1867
Trade Name INFERGEN
Proper Name INTERFERON ALFACON-1
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103663 0 1 1061997 9 MCG03 ML ( 30 MCGML ) 07252013
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 5 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103770 0 3 6191998 50 MGVIAL ( 50 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
103770 0 4 6191998 100 MGVIAL ( 100 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name INTRON A
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103132 0 6 641986 10 MIUML ( 10 MIUML ) 09232013
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103132 0 7 641986 225 MIU15 ML ( 225 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 8 641986 375 MIU15 ML ( 375 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 9 641986 75 MIU15 ML ( 75 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103949 0 5 1192001 675 MCGPEN ( 675 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 6 1192001 108 MCGPEN ( 108 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
March 2018 Page 6 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name PEGINTRON
103949 0 7 1192001 1184 MCGVIAL ( 1184 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 8 1192001 162 MCGPEN ( 162 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 9 1192001 1776 MCGVIAL ( 1776 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 10 1192001 2025 MCGPEN ( 2025 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 11 1192001 222 MCGVIAL ( 222 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No PALATIN TECHNOLOGIES INC 1588
Trade Name NEUTROSPEC TECHNETIUM (99M TC)
Proper Name FANOLESOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103928 0 1 722004 025 MGVIAL ( 025 MGVIAL ) 09222008
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No RECORDATI RARE DISEASES INC 1899
Trade Name ELSPAR
Proper Name ASPARAGINASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
101063 0 1 1101978 10000 IU ( 10000 IUVIAL ) 04092014
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
March 2018 Page 7 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No SCHERING CORP 0994
Trade Name PEGINTRONREBETOL COMBO PACK
Proper Name PEGINTERFERON ALFA-2B AND RIBAVIRIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125196 0 1 6132008 ( 4 (120 MCG05ML) REDIPEN amp 140 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 2 6132008 ( 4 (150 MCG05ML) REDIPEN amp 168 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 3 6132008 ( 4 (150 MCG05ML) REDIPEN amp 196 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 4 6132008 ( 4 (50 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 5 6132008 ( 4 (80 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125422 0 2 10172012 05 MG ( 25 MGML ) 08082017
SOLUTION INTRAVETREAL SINGLE-DOSE VIAL
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125164 0 10 11142007 50 MCGML ( 50 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 8 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
125164 0 11 11142007 100 MCGML ( 100 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 12 11142007 200 MCGML ( 200 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 13 11142007 300 MCGML ( 300 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 14 11142007 400 MCGML ( 400 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 15 11142007 400 MCG06 ML ( 400 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 16 11142007 600 MCGML ( 600 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 17 11142007 600 MCG06 ML ( 600 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 18 11142007 800 MCG06 ML ( 800 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 19 11142007 1000 MCGML ( 1000 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 9 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No CENTOCOR ORTHO BIOTECH PRODUCTS LP 1824
Trade Name ORTHOCLONE OKT3
Proper Name MUROMONAB-CD3
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103463 0 1 9141992 1 MGML ( 1 MGML ) 01112012
SOLUTION INTRAVENOUS AMPULE
ApplicantLicense No EISAI INCORPORATED 1862
Trade Name ONTAK
Proper Name DENILEUKIN DIFTITOX
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103767 0 1 251999 300 MCG2 ML ( 150 MCGML ) 01302014
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No ELI LILLY AND CO 1611
Trade Name XIGRIS
Proper Name DROTRECOGIN ALFA (ACTIVATED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125029 0 1 11212001 5 MGVIAL ( 5 MGVIAL ) 10262011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
125029 0 2 11212001 20 MGVIAL ( 20 MGVIAL ) 10102011
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GENENTECH INC 1048
Trade Name RAPTIVA
Proper Name EFALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125075 0 1 10272003 125 MGVIAL ( 125 MGVIAL ) 09012009
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
Trade Name XOLAIR
March 2018 Page 3 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103976 0 2 6202003 125 MGVIAL ( 125 MGVIAL ) 08252016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103948 0 3 572001 10 MGVIAL ( 10 MGVIAL ) 07062011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name MYOZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125141 0 1 4282006 50 MGVIAL ( 50 MGVIAL ) 10172014
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name BEXXAR THERAPEUTIC REGIME
Proper Name TOSITUMOMAB AND IODINE I-131 TOSITUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125011 0 1 6272003 01 MGML I-131 TOSITUMOMAB ( 01 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 2 6272003 11 MGML I-131 TOSITUMOMAB ( 11 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 3 6272003 14 MGML TOSITUMOMAB ( 14 MGML 03102014 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 4 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No HEMISPHERX BIOPHARMA INC 1703
Trade Name ALFERON N INJECTION
Proper Name INTERFERON ALFA-N3 (HUMAN LEUKOCYTE DERIVED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103158 0 1 10101989 5 MIUVIAL ( 5 MIUVIAL ) 06272013
SOLUTION INTRALESIONAL MULTI-DOSE VIAL
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name ROFERON A
Proper Name INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103145 0 1 641986 3 MIU05 ML ( 3 MIU05 ML ) 06012009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name ZENAPAX
Proper Name DACLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103749 0 1 12101997 25 MG5 ML ( 25 MG5 ML ) 07072011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No KADMON PHARMACEUTICALS LLC 1867
Trade Name INFERGEN
Proper Name INTERFERON ALFACON-1
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103663 0 1 1061997 9 MCG03 ML ( 30 MCGML ) 07252013
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 5 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103770 0 3 6191998 50 MGVIAL ( 50 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
103770 0 4 6191998 100 MGVIAL ( 100 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name INTRON A
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103132 0 6 641986 10 MIUML ( 10 MIUML ) 09232013
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103132 0 7 641986 225 MIU15 ML ( 225 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 8 641986 375 MIU15 ML ( 375 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 9 641986 75 MIU15 ML ( 75 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103949 0 5 1192001 675 MCGPEN ( 675 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 6 1192001 108 MCGPEN ( 108 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
March 2018 Page 6 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name PEGINTRON
103949 0 7 1192001 1184 MCGVIAL ( 1184 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 8 1192001 162 MCGPEN ( 162 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 9 1192001 1776 MCGVIAL ( 1776 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 10 1192001 2025 MCGPEN ( 2025 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 11 1192001 222 MCGVIAL ( 222 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No PALATIN TECHNOLOGIES INC 1588
Trade Name NEUTROSPEC TECHNETIUM (99M TC)
Proper Name FANOLESOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103928 0 1 722004 025 MGVIAL ( 025 MGVIAL ) 09222008
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No RECORDATI RARE DISEASES INC 1899
Trade Name ELSPAR
Proper Name ASPARAGINASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
101063 0 1 1101978 10000 IU ( 10000 IUVIAL ) 04092014
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
March 2018 Page 7 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No SCHERING CORP 0994
Trade Name PEGINTRONREBETOL COMBO PACK
Proper Name PEGINTERFERON ALFA-2B AND RIBAVIRIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125196 0 1 6132008 ( 4 (120 MCG05ML) REDIPEN amp 140 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 2 6132008 ( 4 (150 MCG05ML) REDIPEN amp 168 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 3 6132008 ( 4 (150 MCG05ML) REDIPEN amp 196 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 4 6132008 ( 4 (50 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 5 6132008 ( 4 (80 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125422 0 2 10172012 05 MG ( 25 MGML ) 08082017
SOLUTION INTRAVETREAL SINGLE-DOSE VIAL
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125164 0 10 11142007 50 MCGML ( 50 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 8 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
125164 0 11 11142007 100 MCGML ( 100 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 12 11142007 200 MCGML ( 200 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 13 11142007 300 MCGML ( 300 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 14 11142007 400 MCGML ( 400 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 15 11142007 400 MCG06 ML ( 400 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 16 11142007 600 MCGML ( 600 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 17 11142007 600 MCG06 ML ( 600 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 18 11142007 800 MCG06 ML ( 800 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 19 11142007 1000 MCGML ( 1000 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 9 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No GENENTECH INC 1048
Trade Name XOLAIR
Proper Name OMALIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103976 0 2 6202003 125 MGVIAL ( 125 MGVIAL ) 08252016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No GENZYME CORP 1596
Trade Name CAMPATH
Proper Name ALEMTUZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103948 0 3 572001 10 MGVIAL ( 10 MGVIAL ) 07062011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
Trade Name MYOZYME
Proper Name ALGLUCOSIDASE ALFA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125141 0 1 4282006 50 MGVIAL ( 50 MGVIAL ) 10172014
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No GLAXOSMITHKLINE LLC 1727
Trade Name BEXXAR THERAPEUTIC REGIME
Proper Name TOSITUMOMAB AND IODINE I-131 TOSITUMOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125011 0 1 6272003 01 MGML I-131 TOSITUMOMAB ( 01 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 2 6272003 11 MGML I-131 TOSITUMOMAB ( 11 MGML I- 03102014 131 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
125011 0 3 6272003 14 MGML TOSITUMOMAB ( 14 MGML 03102014 TOSITUMOMAB ) SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
March 2018 Page 4 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No HEMISPHERX BIOPHARMA INC 1703
Trade Name ALFERON N INJECTION
Proper Name INTERFERON ALFA-N3 (HUMAN LEUKOCYTE DERIVED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103158 0 1 10101989 5 MIUVIAL ( 5 MIUVIAL ) 06272013
SOLUTION INTRALESIONAL MULTI-DOSE VIAL
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name ROFERON A
Proper Name INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103145 0 1 641986 3 MIU05 ML ( 3 MIU05 ML ) 06012009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name ZENAPAX
Proper Name DACLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103749 0 1 12101997 25 MG5 ML ( 25 MG5 ML ) 07072011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No KADMON PHARMACEUTICALS LLC 1867
Trade Name INFERGEN
Proper Name INTERFERON ALFACON-1
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103663 0 1 1061997 9 MCG03 ML ( 30 MCGML ) 07252013
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 5 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103770 0 3 6191998 50 MGVIAL ( 50 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
103770 0 4 6191998 100 MGVIAL ( 100 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name INTRON A
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103132 0 6 641986 10 MIUML ( 10 MIUML ) 09232013
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103132 0 7 641986 225 MIU15 ML ( 225 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 8 641986 375 MIU15 ML ( 375 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 9 641986 75 MIU15 ML ( 75 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103949 0 5 1192001 675 MCGPEN ( 675 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 6 1192001 108 MCGPEN ( 108 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
March 2018 Page 6 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name PEGINTRON
103949 0 7 1192001 1184 MCGVIAL ( 1184 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 8 1192001 162 MCGPEN ( 162 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 9 1192001 1776 MCGVIAL ( 1776 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 10 1192001 2025 MCGPEN ( 2025 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 11 1192001 222 MCGVIAL ( 222 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No PALATIN TECHNOLOGIES INC 1588
Trade Name NEUTROSPEC TECHNETIUM (99M TC)
Proper Name FANOLESOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103928 0 1 722004 025 MGVIAL ( 025 MGVIAL ) 09222008
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No RECORDATI RARE DISEASES INC 1899
Trade Name ELSPAR
Proper Name ASPARAGINASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
101063 0 1 1101978 10000 IU ( 10000 IUVIAL ) 04092014
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
March 2018 Page 7 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No SCHERING CORP 0994
Trade Name PEGINTRONREBETOL COMBO PACK
Proper Name PEGINTERFERON ALFA-2B AND RIBAVIRIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125196 0 1 6132008 ( 4 (120 MCG05ML) REDIPEN amp 140 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 2 6132008 ( 4 (150 MCG05ML) REDIPEN amp 168 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 3 6132008 ( 4 (150 MCG05ML) REDIPEN amp 196 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 4 6132008 ( 4 (50 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 5 6132008 ( 4 (80 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125422 0 2 10172012 05 MG ( 25 MGML ) 08082017
SOLUTION INTRAVETREAL SINGLE-DOSE VIAL
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125164 0 10 11142007 50 MCGML ( 50 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 8 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
125164 0 11 11142007 100 MCGML ( 100 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 12 11142007 200 MCGML ( 200 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 13 11142007 300 MCGML ( 300 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 14 11142007 400 MCGML ( 400 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 15 11142007 400 MCG06 ML ( 400 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 16 11142007 600 MCGML ( 600 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 17 11142007 600 MCG06 ML ( 600 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 18 11142007 800 MCG06 ML ( 800 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 19 11142007 1000 MCGML ( 1000 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 9 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No HEMISPHERX BIOPHARMA INC 1703
Trade Name ALFERON N INJECTION
Proper Name INTERFERON ALFA-N3 (HUMAN LEUKOCYTE DERIVED)
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103158 0 1 10101989 5 MIUVIAL ( 5 MIUVIAL ) 06272013
SOLUTION INTRALESIONAL MULTI-DOSE VIAL
ApplicantLicense No HOFFMANN LA ROCHE INC 0136
Trade Name ROFERON A
Proper Name INTERFERON ALFA-2A
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103145 0 1 641986 3 MIU05 ML ( 3 MIU05 ML ) 06012009
SOLUTION SUBCUTANEOUS PREFILLED SYRINGE
Trade Name ZENAPAX
Proper Name DACLIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103749 0 1 12101997 25 MG5 ML ( 25 MG5 ML ) 07072011
SOLUTION INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No KADMON PHARMACEUTICALS LLC 1867
Trade Name INFERGEN
Proper Name INTERFERON ALFACON-1
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103663 0 1 1061997 9 MCG03 ML ( 30 MCGML ) 07252013
SOLUTION SUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 5 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103770 0 3 6191998 50 MGVIAL ( 50 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
103770 0 4 6191998 100 MGVIAL ( 100 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name INTRON A
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103132 0 6 641986 10 MIUML ( 10 MIUML ) 09232013
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103132 0 7 641986 225 MIU15 ML ( 225 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 8 641986 375 MIU15 ML ( 375 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 9 641986 75 MIU15 ML ( 75 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103949 0 5 1192001 675 MCGPEN ( 675 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 6 1192001 108 MCGPEN ( 108 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
March 2018 Page 6 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name PEGINTRON
103949 0 7 1192001 1184 MCGVIAL ( 1184 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 8 1192001 162 MCGPEN ( 162 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 9 1192001 1776 MCGVIAL ( 1776 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 10 1192001 2025 MCGPEN ( 2025 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 11 1192001 222 MCGVIAL ( 222 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No PALATIN TECHNOLOGIES INC 1588
Trade Name NEUTROSPEC TECHNETIUM (99M TC)
Proper Name FANOLESOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103928 0 1 722004 025 MGVIAL ( 025 MGVIAL ) 09222008
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No RECORDATI RARE DISEASES INC 1899
Trade Name ELSPAR
Proper Name ASPARAGINASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
101063 0 1 1101978 10000 IU ( 10000 IUVIAL ) 04092014
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
March 2018 Page 7 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No SCHERING CORP 0994
Trade Name PEGINTRONREBETOL COMBO PACK
Proper Name PEGINTERFERON ALFA-2B AND RIBAVIRIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125196 0 1 6132008 ( 4 (120 MCG05ML) REDIPEN amp 140 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 2 6132008 ( 4 (150 MCG05ML) REDIPEN amp 168 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 3 6132008 ( 4 (150 MCG05ML) REDIPEN amp 196 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 4 6132008 ( 4 (50 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 5 6132008 ( 4 (80 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125422 0 2 10172012 05 MG ( 25 MGML ) 08082017
SOLUTION INTRAVETREAL SINGLE-DOSE VIAL
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125164 0 10 11142007 50 MCGML ( 50 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 8 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
125164 0 11 11142007 100 MCGML ( 100 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 12 11142007 200 MCGML ( 200 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 13 11142007 300 MCGML ( 300 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 14 11142007 400 MCGML ( 400 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 15 11142007 400 MCG06 ML ( 400 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 16 11142007 600 MCGML ( 600 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 17 11142007 600 MCG06 ML ( 600 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 18 11142007 800 MCG06 ML ( 800 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 19 11142007 1000 MCGML ( 1000 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 9 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MEDIMMUNE LLC 1799
Trade Name SYNAGIS
Proper Name PALIVIZUMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103770 0 3 6191998 50 MGVIAL ( 50 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
103770 0 4 6191998 100 MGVIAL ( 100 MGVIAL ) 02282007
POWDER INTRAMUSCULAR SINGLE-DOSE VIAL
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name INTRON A
Proper Name INTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103132 0 6 641986 10 MIUML ( 10 MIUML ) 09232013
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
103132 0 7 641986 225 MIU15 ML ( 225 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 8 641986 375 MIU15 ML ( 375 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
103132 0 9 641986 75 MIU15 ML ( 75 MIU15 ML ) 09232013
SOLUTION SUBCUTANEOUS PREFILLED PEN
Trade Name PEGINTRON
Proper Name PEGINTERFERON ALFA-2B
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103949 0 5 1192001 675 MCGPEN ( 675 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 6 1192001 108 MCGPEN ( 108 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
March 2018 Page 6 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name PEGINTRON
103949 0 7 1192001 1184 MCGVIAL ( 1184 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 8 1192001 162 MCGPEN ( 162 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 9 1192001 1776 MCGVIAL ( 1776 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 10 1192001 2025 MCGPEN ( 2025 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 11 1192001 222 MCGVIAL ( 222 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No PALATIN TECHNOLOGIES INC 1588
Trade Name NEUTROSPEC TECHNETIUM (99M TC)
Proper Name FANOLESOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103928 0 1 722004 025 MGVIAL ( 025 MGVIAL ) 09222008
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No RECORDATI RARE DISEASES INC 1899
Trade Name ELSPAR
Proper Name ASPARAGINASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
101063 0 1 1101978 10000 IU ( 10000 IUVIAL ) 04092014
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
March 2018 Page 7 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No SCHERING CORP 0994
Trade Name PEGINTRONREBETOL COMBO PACK
Proper Name PEGINTERFERON ALFA-2B AND RIBAVIRIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125196 0 1 6132008 ( 4 (120 MCG05ML) REDIPEN amp 140 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 2 6132008 ( 4 (150 MCG05ML) REDIPEN amp 168 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 3 6132008 ( 4 (150 MCG05ML) REDIPEN amp 196 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 4 6132008 ( 4 (50 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 5 6132008 ( 4 (80 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125422 0 2 10172012 05 MG ( 25 MGML ) 08082017
SOLUTION INTRAVETREAL SINGLE-DOSE VIAL
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125164 0 10 11142007 50 MCGML ( 50 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 8 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
125164 0 11 11142007 100 MCGML ( 100 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 12 11142007 200 MCGML ( 200 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 13 11142007 300 MCGML ( 300 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 14 11142007 400 MCGML ( 400 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 15 11142007 400 MCG06 ML ( 400 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 16 11142007 600 MCGML ( 600 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 17 11142007 600 MCG06 ML ( 600 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 18 11142007 800 MCG06 ML ( 800 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 19 11142007 1000 MCGML ( 1000 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 9 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No MERCK AND CO INC DIV MERCK SHARP AND DOHME 0002
Trade Name PEGINTRON
103949 0 7 1192001 1184 MCGVIAL ( 1184 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 8 1192001 162 MCGPEN ( 162 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 9 1192001 1776 MCGVIAL ( 1776 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
103949 0 10 1192001 2025 MCGPEN ( 2025 MCGPEN ) 10142016
POWDER SUBCUTANEOUS PREFILLED PEN
103949 0 11 1192001 222 MCGVIAL ( 222 MCGVIAL ) 10012016
POWDER SUBCUTANEOUS SINGLE-DOSE VIAL
ApplicantLicense No PALATIN TECHNOLOGIES INC 1588
Trade Name NEUTROSPEC TECHNETIUM (99M TC)
Proper Name FANOLESOMAB
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
103928 0 1 722004 025 MGVIAL ( 025 MGVIAL ) 09222008
POWDER INTRAVENOUS SINGLE-DOSE VIAL
ApplicantLicense No RECORDATI RARE DISEASES INC 1899
Trade Name ELSPAR
Proper Name ASPARAGINASE
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
101063 0 1 1101978 10000 IU ( 10000 IUVIAL ) 04092014
POWDER INTRAVENOUS INTRAMUSCULAR SINGLE-DOSE VIAL
March 2018 Page 7 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No SCHERING CORP 0994
Trade Name PEGINTRONREBETOL COMBO PACK
Proper Name PEGINTERFERON ALFA-2B AND RIBAVIRIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125196 0 1 6132008 ( 4 (120 MCG05ML) REDIPEN amp 140 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 2 6132008 ( 4 (150 MCG05ML) REDIPEN amp 168 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 3 6132008 ( 4 (150 MCG05ML) REDIPEN amp 196 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 4 6132008 ( 4 (50 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 5 6132008 ( 4 (80 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125422 0 2 10172012 05 MG ( 25 MGML ) 08082017
SOLUTION INTRAVETREAL SINGLE-DOSE VIAL
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125164 0 10 11142007 50 MCGML ( 50 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 8 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
125164 0 11 11142007 100 MCGML ( 100 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 12 11142007 200 MCGML ( 200 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 13 11142007 300 MCGML ( 300 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 14 11142007 400 MCGML ( 400 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 15 11142007 400 MCG06 ML ( 400 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 16 11142007 600 MCGML ( 600 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 17 11142007 600 MCG06 ML ( 600 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 18 11142007 800 MCG06 ML ( 800 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 19 11142007 1000 MCGML ( 1000 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 9 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No SCHERING CORP 0994
Trade Name PEGINTRONREBETOL COMBO PACK
Proper Name PEGINTERFERON ALFA-2B AND RIBAVIRIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125196 0 1 6132008 ( 4 (120 MCG05ML) REDIPEN amp 140 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 2 6132008 ( 4 (150 MCG05ML) REDIPEN amp 168 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 3 6132008 ( 4 (150 MCG05ML) REDIPEN amp 196 (200 MG) 06252009 CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 4 6132008 ( 4 (50 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
125196 0 5 6132008 ( 4 (80 MCG05ML) REDIPEN amp 112 (200 06252009 MG) CAPSULES RIBAVIRIN ) POWDER amp CAPSULE (COMBO KIT) SUBCUTANEOUS ORAL
ApplicantLicense No THROMBOGENICS INC 1866
Trade Name JETREA
Proper Name OCRIPLASMIN
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125422 0 2 10172012 05 MG ( 25 MGML ) 08082017
SOLUTION INTRAVETREAL SINGLE-DOSE VIAL
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
Proper Name METHOXYPOLYETHYLENE GLYCOL EPOETIN BETA
BLASTN Product Approval Date PotencyDosage FormRoutePresentation Date added to Discontinued List
125164 0 10 11142007 50 MCGML ( 50 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 8 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
125164 0 11 11142007 100 MCGML ( 100 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 12 11142007 200 MCGML ( 200 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 13 11142007 300 MCGML ( 300 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 14 11142007 400 MCGML ( 400 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 15 11142007 400 MCG06 ML ( 400 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 16 11142007 600 MCGML ( 600 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 17 11142007 600 MCG06 ML ( 600 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 18 11142007 800 MCG06 ML ( 800 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 19 11142007 1000 MCGML ( 1000 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 9 of 9
CDER Discontinued Biologic Product List
ApplicantLicense No VIFOR INTERNATIONAL AG 2039
Trade Name MIRCERA
125164 0 11 11142007 100 MCGML ( 100 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 12 11142007 200 MCGML ( 200 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 13 11142007 300 MCGML ( 300 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 14 11142007 400 MCGML ( 400 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 15 11142007 400 MCG06 ML ( 400 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 16 11142007 600 MCGML ( 600 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
125164 0 17 11142007 600 MCG06 ML ( 600 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 18 11142007 800 MCG06 ML ( 800 MCG06 ML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS PREFILLED SYRINGE
125164 0 19 11142007 1000 MCGML ( 1000 MCGML ) 09242008
SOLUTION INTRAVENOUSSUBCUTANEOUS SINGLE-DOSE VIAL
March 2018 Page 9 of 9