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User Fee Billable Biologic Products and Potencies Approved Under Section 351 of the PHS Act

(Back to CBER Reports)

This list is intended to include all CBER user fee billable biologic products and potencies approved under Section 351 of the Public Health Service Act** and subject to the Prescription Drug User Fee Act (PDUFA).

A product fee is assessed for each potency in which the approved (non-revoked, non-suspended) product is manufactured in final dosage form. In certain circumstances, products which have been discontinued from marketing but are still licensed are not assessed product fees. These products are identified on CBER's Discontinued List. Generally, a licensed product is added to the Discontinued List when the Applicant informs CBER's user fee staff that the product is no longer marketed.

The potency information contained in this list is based on current information in CBER's regulatory database. Companies are responsible for alerting CBER to any discrepancies regarding potency or proprietary name information. Any such discrepancies should be reported to CBER's PDUFA billing staff at CBERPDUFAStaff@fda.hhs.gov.

This list is updated bi-annually in September and March.

**A number of therapeutic biologic products are regulated by the Center for Drug Evaluation and Research (CDER).  To view the listing of CDER regulated biologics, see the CDER Billable Biologic Product List.

Applicant/
License No.

Proprietary Name /
Proper Name

STN

Approval Date

Billable Potencies

ALK-Abello, Inc
License 1256

Histatrol
Positive Skin Test Control - Histamine

103754/0

2/23/1998

0.1 mg/mL
1 mg/mL

Baxter Healthcare Corp
License 0140

Buminate, Flexbumin
Albumin (Human)

101452/0

3/3/1954

5%
20%
25%

Aralast
Alpha-1 Proteinase Inhibitor (Human)

125039/0

12/23/2002

0.5 g/vial
1 g/vial

Feiba NF
Anti-Inhibitor Coagulant Complex

101447/5352

5/27/2009

500 u/vial
1000 u/vial
2500 u/vial

Hemofil M
Antihemophilic Factor (Human)

101448/0

3/11/1966

250 IU/vial
500 IU/vial
1000 IU/vial
1700 IU/vial

Advate
Antihemophilic Factor (Recombinant) Plasma/Albumin Free
Method

125063/0

7/25/2003

7/12/2012

250 IU/vial
500 IU/vial
1,000 IU/vial
1,500 IU/vial
2,000 IU/vial
3,000 IU/vial
4,000 IU/vial

Recombinate
Antihemophilic Factor (Recombinant)

103375/0

12/10/1992

250 IU/vial
500 IU/vial
1,000 IU/vial
1,500 IU/vial
2,000 IU/vial

Bebulin
Factor IX Complex

103112/5315

4/7/2011

200-1200 u – 20mL vial

Tisseel
Fibrin Sealant

103980/0

2/7/2000

2 mL (lyophilized)
4 mL(lyophilized)
10 mL(lyophilized)

Tisseel
Fibrin Sealant

103980/5121

7/27/2006

3,000 KIU/500 IU/mL (frozen solution in 2, 4, and 10 mL prefilled syringes)

Artiss
Fibrin Sealant (Human)

125266/0

3/19/2008

3,000 KIU/4 IU/mL (frozen solution in 2, 4, and 10 mL prefilled syringes)

Gammagard Liquid
Immune Globulin Infusion (Human)

125105/0

4/27/2005

10% (100 mg/mL)

Gammagard S/D
Immune Globulin Intravenous (Human)

103133/0

2/18/1986

5.0 g/vial
10 g/vial

Protenate
Plasma Protein Fraction (Human)

101454/0

6/16/1960

5%

Ceprotin
Protein C Concentrate (Human)

125234/0

3/30/2007

500 IU/vial
1,000 IU/vial

RIXUBIS
Coagulation Factor IX (Recombinant)

125446/0

6/26/2013

250 IU/vial
500 IU/vial
1,000 IU/vial
2,000 IU/vial
3,000 IU/vial

Bayer Healthcare LLC
License 0008

Kogenate FS
Antihemophilic Factor (Recombinant)

103332/0

2/25/1993

250 IU/vial
500 IU/vial
1,000 IU/vial
2,000 IU/vial
3,000 IU/vial

Biogen Idec Inc.
License 1697
 

ELOCTATE
Antihemophilic Factor (Recombinant), Fc Fusion Protein

125487/06/6/2014

250 IU/vial
500 IU/vial
750 IU/vial
1,000 IU/vial
1,500 IU/vial
2,000 IU/vial
3,000 IU/vial

ALPROLIX
Coagulation Factor IX
(Recombinant), Fc
Fusion Protein
125444/03/28/2014500 IU/vial
1,000 IU/vial
2,000 IU/vial
3,000 IU/vial

Bio Products Laboratory
License 1811

Gammaplex
Immune Globulin Intravenous (Human)

125329/0

9/17/2009

5%

Biotest Pharmaceuticals Corp
License 1792

Nabi-HB
Hepatitis B Immune Globulin (Human)

103945/0

10/23/2001

>312 IU/mL

Bivigam
Immune Globulin Intravenous (Human)
 
125389/012/19/201210% (100mg/mL)

BTG International Inc.
License 1861

CroFab
Crotalidae Polyvalent Immune Fab (Ovine)

103788/0

10/2/2000

1g/vial

DigiFab
Digoxin Immune Fab
(Ovine)

103910/0

8/31/2001

40 mg/vial

California Department of Public Health
License 1797

Baby BIG
Botulism Immune Globulin Intravenous (Human)

125034/0

10/23/2003

100 mg/vial

Cangene Corp
License 1201

BAT
Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) – (Equine)

125462/0

3/22/2013

>4,500 u/10 – 22 mL/vial

HepaGamB, HepaGam BT
Hepatitis B Immune Globulin (Human)

125035/0

1/27/2006

>312 IU/mL

WinRho SDF Liquid
Rho(D) Immune Globulin Intravenous (Human)

103649/5107

3/31/2005

1,500 IU/mL

CNJ-016
Vaccinia Immune Globulin Intravenous (Human)

125109/0

5/2/2005

>50,000 u/15mL

VariZIG
Varicella Zoster Immune Globulin (Human)
 
125430/012/20/2012125 IU/vial
Crucell Switzerland LTD License 1841Vivotif
Typhoid Vaccine Live
Oral Ty21a
 

103123/0

12/15/1989

2-6.8 bil cfu/capsule

CSL Behring AG
License 1766

AlbuRx
Albumin (Human)

102366/0

7/23/1976

5%
25%

Cytogam
Cytomegalovirus Immune Globulin Intravenous (Human)

103189/0

4/17/1990

5%

Carimune NF,
Panglobulin,
Sandoglobulin

Immune Globulin Intravenous (Human)

102367/0

6/7/1984

3 g/vial
6 g/vial
12 g/vial

Hizentra
Immune Globulin Subcutaneous (Human), 20% Liquid

125350/0

3/4/2010

20% (1 g/5 mL, 2 g/10 mL, 4 g/20 mL)

Privigen
Immune Globulin Intravenous (Human), 10% Liquid

125201/0

7/26/2007

10% (2.5 g/25 mL, 5 g/50 mL, 10 g/100 mL, 20 g/200 mL and 40 g/400 mL vials)

Rhophylac
Rho(D) Immune Globulin Intravenous (Human)

125070/0

2/12/2004

1,500 IU/syringe

CSL Behring GmbH
License 1765

Berinert
C1 Esterase Inhibitor (Human)

125287/0

10/9/2009

500 u/vial

Humate-P
Antihemophilic Factor / von Willebrand Factor Complex (Human)

103960/0

4/11/2000

250 IU/vial
500 IU/vial
1,000 IU/vial

Corifact
Factor XIII Concentrate
(Human)

125385/0

2/17/2011

1,000-1,600 units/vial

RiaSTAP
Fibrinogen Concentrate
(Human)

125317/0

1/16/2009

1 g/vial (900 - 1,300 mg)

Kcentra
Prothrombin Complex Concentrate (Human)

125421/0

4/29/2013

500 IU/vial

CSL Behring LLC
License 1767

Albuminar
Albumin (Human)

103955/0

3/17/2000

5%
20%
25%

Zemaira
Alpha-1-Proteinase
Inhibitor (Human)

125078/0

7/8/2003

1.0 g/vial

Monoclate-P
Antihemophilic Factor
(Human)

103953/0

3/17/2000

250 IU/vial
500 IU/vial
1000 IU/vial
1500 IU/vial

Mononine
Coagulation Factor IX
(Human)

103957/0

3/17/2000

500 IU/vial
1000 IU/vial

CSL Limited
License 1764

Afluria
Influenza Virus Vaccine

125254/0

9/28/2007

15 mcg/0.5 mL

Dendreon Corporation
License 1749

Provenge
Sipuleucel-T

125197/0

4/29/2010

50 million CD54+ cells in 250 mL

Emergent BioDefense Operations Lansing, Inc.
License 1755

Biothrax
Anthrax Vaccine
Adsorbed

103821/0

11/12/1998

0.5 mL/vial

Ethicon, Inc. License 1879

EVARREST
Fibrin Sealant Patch
 
125392/012/5/20124x4 inch unit with 50.3 mg/in
Human Fibrinogen and
203.2 IU/in Human Thrombin
 

Fibrocell Technologies,Inc. License 1818

LaViv
Azficel-T

125348/0

6/21/2011

18 mu/1.2 mL

Genzyme Biosurgery
License 1659

Carticel SM Service
Autologous Cultured Chondrocytes

103661/0

8/22/1997

12 mil/vial

Genzyme Corp
License 1596

Thymoglobulin
Anti-thymocyte Globulin
(Rabbit)

103869/0

5/19/1999

25 mg/vial

GlaxoSmithKline Biologicals
License 1617


 

Infanrix
Diphtheria & Tetanus
Toxoids & Acellular
Pertussis Vaccine
Adsorbed

103647/0

1/29/1997

25Lf/10Lf/25mcg/0.5mL

Kinrix
Diphtheria and Tetanus
Toxoids, Acellular Pertussis Vaccine Adsorbed and Inactivated Poliovirus Vaccine

125260/0

6/24/2008

0.5 mL/vial

Pediarix
DTaP & Hepatitis B (Recombinant) & Inactivated Polio Virus Vaccine

103907/0

12/13/2002

0.5 mL/vial

Twinrix
Hepatitis A Inactivated & Hepatitis B (Recombinant) Vaccine

103850/0

5/11/2001

1 mL/vial

Havrix
Hepatitis A Vaccine Inactivated

103475/0

2/22/1995

1440 ELISA u/mL

Hiberix
Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)

125347/0

8/19/2009

10 mcg/25 mcg vial

Engerix-B
Hepatitis B Vaccine (Recombinant)

103239/0

8/28/1989

10 mcg/0.5 mL vial

Cervarix
Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant

125259/0

10/16/2009

0.5 mL/vial

Fluarix
Influenza Virus Vaccine

125127/0

8/31/2005

45 mcg/0.5 mL

Fluarix Quadrivalent
Influenza Virus Vaccine
 
125127/51312/14/201260 mcg/0.5 mL

Menhibrix
Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine

125363/0

6/24/2012

0.5 mL/vial

Rotarix
Rotavirus Vaccine, Live, Oral

125265/0

4/3/2008

1 mL/dose

Boostrix
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed

125106/0

5/3/2005

2.5Lf/5Lf/2.5mcg/8mcg/0.5mL

Grifols Biologicals, Inc
License 1694

Albutein
Albumin (Human)

102478/0

8/15/1978

5%
20%
25%

Alphanate
Antihemophilic Factor/Von Willebrand Factor Complex (Human)

102475/0

8/15/1978

250 IU/vial
500 IU/vial
1000 IU/vial
1500 IU/vial

AlphaNine SD
Coagulation Factor IX (Human)

103249/0

12/31/1990

500 IU/vial
1000 IU/vial
1500 IU/vial

Profilnine SD
Factor IX Complex

102476/0

7/20/1981

500 IU/vial
1000 IU/vial
1500 IU/vial

Grifols Therapeutics, Inc.
License 1871

Plasbumin
Albumin (Human), USP

101138/0

10/21/1942

5%
20%
25%

Prolastin-C
Alpha-1-Proteinase Inhibitor (Human)

103174/0

12/2/1987

1,000 mg/vial

Koate-DVI
Antihemophilic Factor (Human)

101130/0

1/24/1974

250 IU/vial
500 IU/vial
1,000 IU/vial

Thrombate III
Antithrombin III (Human)

103196/0

12/30/1991

500 IU/vial
 

HyperHep B S/D
Hepatitis B Immune Globulin (Human)

101146/0

9/23/1977

220 IU/mL

GammaSTAN S/D
Immune Globulin (Human)

101134/0

1/11/1944

16.5%

Gamunex-C
Immune Globulin Injection
(Human), 10%, Caprylate/Chromatography Purified

125046/0

8/27/2003

10%

Plasmanate
Plasma Protein Fraction (Human), USP

101140/0

10/2/1958

5%

HyperRAB S/D
Rabies Immune Globulin (Human)

101144/0

6/12/1974

150 IU/mL

HyperRHO S/D
Rho(D) Immune Globulin (Human)

101141/0

6/11/1971

250 IU/vial
1500 IU/vial

HyperTET S/D
Tetanus Immune Globulin (Human)

101142/0

10/17/1957

250 u/syringe

ID Biomedical Corp of Quebec
License 1739

FluLaval
Influenza Virus Vaccine

125163/0

10/5/2006

15 mcg/0.5 mL vial

FluLaval Quad
Influenza Virus Vaccine

125163/2538/15/20130.5 mL
Influenza A (H5N1)
Virus Monovalent Vaccine, Adjuvanted
125419/011/22/20130.5 mL/vial

Instituto Grifols, SA
License 1181

Albumin (Human)

103352/0

2/17/1995

20%
25%

Flebogamma
Immune Globulin Intravenous (Human)

125077/0 125077/146

12/15/2003 7/27/2010

5%
10%

JHP Pharmaceuticals LLC
License 1781

Aplisol
Tuberculin, Purified Protein Derivative

103782/0

4/20/1998

5 TU/0.1 mL

Jubilant
HollisterStier LLC
License 1272

Positive Skin Test Control-Histamine

103891/0

6/2/1999

6 mg/mL

Kamada Ltd.
License 1826

Glassia
Alpha-1-Proteinase Inhibitor (Human)

125325/0

7/1/2010

1 g/vial

Kedrion, S.p.A.
License 1851

Kedbumin
Albumin (Human)

125384/0

6/3/2011

50 mL/vial

MassBioLogics
License 1779

Tetanus and Diphtheria Toxoids Adsorbed

101322/0

7/27/1970

0.5 mL/vial

MedImmune LLC
License 1799

Flumist Quad
Influenza Virus Vaccine Live, Intranasal

125020/1668

2/29/2012

0.2 mL

Merck Sharp & Dohme Corp.
License 0002

Antivenin (Latrodectus mactans)

101062/0

2/13/1936

nlt 6000 u/vial

COMVAX
Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine

103623/0

10/2/1996

7.5 mcg PRP/125 mcg OMPC/5 mcg HBsAg/0.5mL vial

PedvaxHIB
Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)

103237/0

12/20/1989

7.5 mcg/0.5mL

VAQTA
Hepatitis A Vaccine Inactivated

103606/0

3/29/1996

50 u/mL

Recombivax,
Recombivax HB
Hepatitis B Vaccine (Recombinant)

101066/0

7/23/1986

10 mcg/mL
40 mcg/mL

GARDASIL
Human Papillomavirus Quadrivalent(Types 6, 11, 16, 18) Vaccine, Recombinant

125126/0

6/8/2006

120 mcg HPV 6 L1 Protein mg/0.5 mL/syringe

M-M-R II
Measles, Mumps and Rubella Virus Vaccine Live

101069/0

4/22/1971

0.5 mL/vial

ProQuad
Measles, Mumps, Rubella and Varicella Virus Vaccine Live

125108/0

9/6/2005

0.5 mL/vial

Normal Horse Serum

101084/0

1/2/1959

 

Pneumovax 23
Pneumococcal Vaccine, Polyvalent

101094/0

11/21/1977

25 mcg/0.5 mL vial

RotaTeq
Rotavirus Vaccine, Live, Oral Pentavalent

125122/0

2/3/2006

2 mL/tube

Varivax
Varicella Virus Vaccine Live

103552/0

3/17/1995

nlt 1350 pf u/0.5mL

Zostavax
Zoster Vaccine Live

125123/0

5/25/2006

0.65 mL/vial

Nielsen Bioscience, Inc.
License 1903

Spherusol
Coccidioides immitis Spherule-Derived Skin Test Antigen
125354/07/29/20110.1 mL/vial

Novartis Vaccines and Diagnostics GmbH License 1754

RabAvert
Rabies Vaccine

103334/0

10/20/1997

2.5 u/vial

Novartis Vaccines and Diagnostics, Inc.
License 1751

Agriflu
Influenza Vaccine

125297/0

11/27/2009

.05 mL/syringe

Flucelvax
Influenza Virus Vaccine
 
125408/0

11/20/2012

0.5 mL/syringe

Menveo
Meningococcal [Groups A, C, Y, and W 135] Oligosaccharide Diphtheria CRM197 Conjugate Vaccine

125300/0

2/19/2010

0.5 mL/vial

Novartis Vaccines and Diagnostics Limited
License 1750

FluVirin
Influenza Virus Vaccine

103837/0

11/3/1998

15 mcg/0.5 mL


Novo Nordisk, Inc.
License 1261

Novoeight
Antihemophilic Factor
(Recombinant)
 
125466/010/15/2013250 IU/vial
500 IU/vial 1,000 IU/vial 1,500 IU/vial 2,000 IU/vial 3,000 IU/vial
 
TRETTEN Coagulation Factor XIII A Subunit (Recombinant)125398/012/23/20132,500 IU/vial

NovoSeven, NovoSeven RT
Coagulation Factor VIIa (Recombinant)

103665/0
103665/5605

3/25/1999
8/6/2010

1 mg/vial
2 mg/vial
5 mg/vial
8 mg/vial

Octapharma Pharmazeutika Produktionsges.m.b.H.
License 1646

Albumin (Human)


 

125154/0

10/17/2006

5%
20%
25%

Octagam
Immune Globulin Intravenous (Human)

125062/0

5/21/2004

5%

OCTAPLAS
Pooled Plasma (Human)
Solvent/Detergent Treated
 

125416/0

1/17/2013

45-70 mg/200mL bag

Wilate
von Willebrand Factor/Coagulation Factor VIII Complex (Human)

125251/22
 

12/20/2010

500 IU/vial
1,000 IU/vial
 

OMRIX biopharmaceuticals, Ltd
License 1603

Evicel
Fibrin Sealant (Human)

125010/0

3/21/2003

1 mL kit
2 mL kit
5 mL kit

Evithrom
Thrombin, Topical (Human)

125247/0
125247/89
 

8/27/2007
9/17/2009
 

800-1,200 IU/mL solution
1,600-2,400 IU/vial
(lyophilized powder)
 

Organon Teknika Corp LLC
License 1747

Tice BCG
BCG Live

102821/0

6/21/1989

100-800 mil cfu/vial

BCG Vaccine

103050/0

6/21/1989

100-800 mil cfu/vial

Ortho-Clinical Diagnostics, Inc
License 1236

RhoGAM
Rho(D) Immune Globulin (Human)

103777/0

4/23/1998

50 mcg
300 mcg

Pharmacia & Upjohn Company
License 1216

Atgam
Lymphocyte Immune Globulin, Anti-thymocyte Globulin (Equine)

103676/0

12/4/1996

50 mg/mL

Pharming Group NV
License 1857

RUCONEST
C1 Esterase Inhibitor (Recombinant)

125495/07/16/20142,100 IU/vial
Protein Sciences Corporation License 1795

FluBlok
Influenza Vaccine

125285/01/16/20130.5 mL/vial

Rare Disease Therapeutics, Inc. (RDT) License 1860

Anascorp
Centruroides (Scorpion) Immune
F(ab')2 (Equine) Injection

125335/0

8/3/2011

not >120 mg/vial

Recordati Rare Diseases, Inc. License 1899

Panhematin
Hemin for Injection

101246/0

7/20/1983

313 mg/vial

rEVO Biologics, Inc.
License 1904
ATryn
Antithrombin
(Recombinant)
 
125284/02/6/20091750 IU/vial

Sanofi Pasteur Biologics Co.
License 1815

ACAM2000
Smallpox (Vaccinia) Vaccine, Live

125158/0

8/31/2007

1 – 5 x 10 8 PFU/mL

Sanofi Pasteur, Inc
License 1725

Fluzone/Fluzone High Dose/Fluzone Intradermal/Fluzone Quadrivalent
Influenza Virus Vaccine

103914/0
103914/5240
103914/5369
103914/5574

12/9/1999
12/23/2009
5/9/2011
6/7/2013

45 mcg/0.5mL
180 mcg/0.5mL
27 mcg/0.1mL
60 mcg/0.5mL

Menactra
Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine

125089/0

1/14/2005

48 mcg/0.5mL
 

Menomune
Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W135 Combined

103926/0

12/9/1999

50 mcg/0.5mL

Tetanus Toxoid Adsorbed

103913/0

12/9/1999

5Lf/0.5mL

DECAVAC
Tetanus and Diphtheria Toxoids Adsorbed For Adult Use

103921/0

12/9/1999

5Lf/2Lf/0.5mL

YF-Vax
Yellow Fever Vaccine

103915/0

12/9/1999

4.74 pfu/0.5mL

Sanofi Pasteur Limited
License 1726

TheraCys
BCG Live

103943/0

2/24/2000

81 mg/vial

Daptacel
Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed

103666/0

5/14/2002

15 Lf/5 Lf/PT 10 mcg/FHA 5 mcg/PRN 3 mcg/FIM 5 mcg/0.5mL

Diphtheria & Tetanus Toxoids Adsorbed

103944/0

2/24/2000

25Lf/5Lf/0.5mL

Pentacel
Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) Reconstituted with Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Combined with Poliovirus Vaccine Inactivated

125145/0

6/20/2008

0.5 mL/vial
 

TENIVAC
Tetanus and Diphtheria Toxoids Adsorbed for Adult Use

103171/0

11/3/2003

5 Lf/2 Lf/0.5mL

Adacel
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed

125111/0

6/10/2005

T5Lf/d2Lf/PT2.5 mcg/FHA5mcg/PRN 3mcg/FIM5mcg/0.5mL

Tubersol
Tuberculin, Purified Protein Derivative

103941/0

2/24/2000

5 TU/mL

Sanofi Pasteur SA
License 1724

ActHIB, OmniHIB
Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)

103935/0

2/4/2000

0.5 mL/vial

IPOL
Poliovirus Vaccine Inactivated (Monkey Kidney Cell)

103930/0

2/4/2000

32/40/8 D AU/0.5mL

Imogam, Rabies HT
Rabies Immune Globulin (Human)

103932/0

2/4/2000

150 IU/vial

Imovax Rabies
Rabies Vaccine

103931/0

2/4/2000

(IM) 2.5 IU/mL

Typhim Vi
Typhoid Vi
Polysaccharide Vaccine

103936/0

2/4/2000

25 mcg/0.5mL

Takeda Pharma
License 1894

TachoSil
Fibrin Sealant Patch

125351/0

4/5/2010

3.0 cm x 2.5 cm
4.8 cm x 4.8 cm
9.5 cm x 4.8 cm

Teva Women's Health, Inc.
License 1804

Adenovirus Type 4 and Type 7 Vaccine, Live, Oral

125296/0

3/16/2011

Type 4, NFT 32000 TCI doses and Type 7 NFT 32000 TCI doses

The Medicines Company
License 1902  
RECOTHROM
Theombin topical
(Recombinant)
 
125248/01/17/20085,000 IU/vial
20,000 IU/vial
 
Valneva Austria GmbH License 1909Ixiaro
Japanese Encephalitis Virus Vaccine Inactivated
 
125280/03/30/20090.5 mL/syringe

ViroPharma Biologics, Inc.
License 1833

Cinryze
C1 Esterase Inhibitor (Human)

125267/0

10/10/2008

500 u/vial

Wyeth Pharmaceuticals, Inc
License 0003

XYNTHA, XYNTHA SOLOFUSE
Antihemophilic Factor (Recombinant), Plasma/Albumin Free

125264/0
 

125264/492

2/21/2008
 

8/6/2010

250 IU/vial
500 IU/vial
1,000 IU/vial
2,000 IU/vial
3,000 IU/mL

BeneFIX
Coagulation Factor IX (Recombinant)

103677/0

2/11/1997



11/23/2011

250 IU/mL
500 IU/mL
1,000 IU/mL
2,000 IU/mL
3,000 IU/ml

Prevnar
Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein)

103905/0

2/17/2000

0.5 mL/vial

Prevnar 13
Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)

125324/0

2/24/2010

0.5 mL/syringe

Center for Biologics Evaluation and Research
Discontinued Products List (Products no longer Marketed)
 
 


Applicant

Proprietary Name /
Product Name

STN

Potency(s)

Approval Date

Date added to Discontinued list

Baxter Healthcare Corp

Artiss
Fibrin Sealant (Human)
125266/02 mL kit
4 mL kit   
10 mL kit (lyophilized powder)
3/19/20089/3/2014
Gammagard S/D
Immune Globulin Intravenous (Human)
103133/0

0.5 g/vial
2.5g/vial

2/18/19869/3/2014

Iveegam EN
Immune Globulin
Intravenous (Human)

103133/0

500 mg/vial
1,000 mg/vial 2,500 mg/vial 5,000 mg/vial

2/18/1986

9/24/2008

Feiba VH
Anti-Inhibitor
Coagulant Complex

101447/0

5,00 IU/vial
1,000 IU/vial
2,500 IU/vial
 

12/21/1979

9/14/2011

Bebulin VH
Factor IX Complex

103112/0

200-1200 u-20ml vial

8/21/1970

9/14/2011

Cangene Corp.

WinRho SDF
Rho(D) Immune Globulin Intravenous (Human)

103649/0

600, 1,500, 5,000 IU/vial
(lyophilized powder)

4/2/1996

10/1/2007

CSL Limited

Influenza A (H1N1) 2009 Monovalent

125254/127

15 mcg/0.5mL

9/15/2009

9/24/2010

Emergent BioDefense Operations Lansing Inc.

BioRab
Rabies Vaccine
Adsorbed,

103820/0

1.0 mL/vial

11/12/1998

10/1/2007

Greer Laboratories, Inc.

Plague Vaccine

103569/0

2 bil. cell/mL

10/5/1994

10/1/2007

Grifols Biologicals, Inc.

AlphaNine SD
Coagulation Factor IX
(Human)

103249/0

250 IU/vial

12/31/1990

9/24/2008

ID Biomedical Corp of Quebec

Influenza A (H1N1) 2009 Monovalent

125163/135

15 mcg/0.5 mL

11/10/2009

12/15/10

MedImmune, LLC

Flumist
Influenza Virus Vaccine Live, Intranasal

125020/0

10 x 6.5-7.5 TCID

6/17/2003

9/12/2013

Influenza A (H1N1) 2009 Monovalent

125020/1215

1 x 10 (6.5-7.5) FU/0.2mL

9/15/2009

9/24/2010

Nielsen Bioscience, Inc.

Positive Skin Test Control-Histamine

103317/0

1.8 mg/mL

2/14/1992

10/1/2007

Novartis Vaccines and Diagnostics Limited

Influenza A (H1N1) 2009 Monovalent

103837/5514

15 mcg/0.5 mL

9/15/2009

9/24/2010

Novo Nordisk, IncNovoSeven
Coagulation Factor VIIa (Recombinant)
103665/01.2 mg/vial
2.4 mg/vial
4.8 mg/vial
3/25/19999/14/2011

Organogenesis, Inc.
License 1863

GINTUIT
Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen

125400/0

>0.000001 mcg/mL
 

3/9/2012

9/3/2014

Sanofi Pasteur, Inc.

Diphtheria & Tetanus Toxoids Adsorbed

103919/0

6.6; 5 UNT;Units

12/9/1999

9/12/2013

Tripedia
Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed

103922/0

6.7Lf/5Lf/46.8 mcg/0.5mL

12/9/1999

9/12/2013

Influenza A (H1N1) 2009 Monovalent

103914/5260

15 mcg/0.5 mL

9/15/2009

9/24/2010

Influenza Virus Vaccine, H5N1

125244/0

90 mcg/0.5mL

4/17/2007

9/14/2011

Menomune-A/C
Meningoccal Polysaccharide Vaccine, Groups A and C Combined

103925/0

50 mcg/0.5mL

12/9/1999

9/14/2011

Sanofi Pasteur Limited

Poliovax
Poliovirus Vaccine Inactivated (Human Diploid Cell)

103940/0

0.5mL/vial

2/24/2000

9/14/2011

Talecris Biotherapeutics, Inc.

Prolastin-C
Alpha-1-Proteinase Inhibitor (Human)
 

103174/0

500 mg/vial

12/2/1987

3/23/2011

Wellcome Foundation Limited Wellcome Research Laboratories

Digibind
Digoxin Immune Fab
(Ovine)

103141/0

38 mg/vial

4/22/1986

9/14/2011

Wyeth Pharmaceuticals, Inc.

Antivenin (Crotalidae) Polyvalent

101098/0

10 mL/vial

2/8/1954

10/1/2007

Antivenin (Micrurus fulvius)101099/010 mL/vial8/28/196710/1/2007

ReFacto
Antihemophilic Factor (Recombinant)

103779/0

250 IU/vial
500 IU/vial
1,000 IU/vial
2,000 IU/vial

3/6/2000

7/24/2012