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User Fee Billable Biologic Products and Potencies Approved Under Section 351 of the PHS Act
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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**.
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. Products may also be added if annual reports indicate 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 user fee billing staff at 301-827-3503.
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 biologics regulated by CDER see the CDER Billable Biologic Product List.
Applicant/ License No. | Proprietary Name / | STN | Approval Date | Billable Potencies |
ALK-Abello, Inc | Histatrol | 103754/0 | 2/23/1998 | 0.1 mg/mL |
Baxter Healthcare Corp | Buminate, Flexbumin | 101452/0 | 3/3/1954 | 5% |
Aralast | 125039/0 | 12/23/2002 | 0.5 g/vial | |
Feiba NF | 101447/5352 | 5/27/2009 | 500 u/vial | |
Hemofil M | 101448/0 | 3/11/1966 | 250 IU/vial | |
Advate | 125063/0 |
7/25/2003
7/12/2012 | 250 IU/vial | |
Recombinate | 103375/0 | 12/10/1992 | 250 IU/vial | |
Bebulin | 103112/5315 | 4/7/2011 | 200-1200 u – 20mL vial | |
Tisseel | 103980/0 | 2/7/2000 | 2 mL (lyophilized) | |
Tisseel | 103980/5121 | 7/27/2006 | 3,000 KIU/500 IU/mL (frozen solution in 2, 4, and 10 mL prefilled syringes) | |
Artiss | 125266/0 | 3/19/2008 | 2 mL kit (lyophilized) | |
Artiss | 125266/0 | 3/19/2008 | 3,000 KIU/4 IU/mL (frozen solution in 2, 4, and 10 mL prefilled syringes) | |
Gammagard Liquid | 125105/0 | 4/27/2005 | 10% (100 mg/mL) | |
Gammagard S/D | 103133/0 | 2/18/1986 | 0.5 g/vial | |
Protenate | 101454/0 | 6/16/1960 | 5% | |
Ceprotin | 125234/0 | 3/30/2007 | 500 IU/vial | |
Bayer Healthcare LLC | Kogenate FS | 103332/0 | 2/25/1993 | 250 IU/vial |
Bio Products Laboratory | Gammaplex | 125329/0 | 9/17/2009 | 5% |
Biotest Pharmaceuticals Corp | Nabi-HB | 103945/0 | 10/23/2001 | >312 IU/mL |
BTG International Inc. | CroFab | 103788/0 | 10/2/2000 | 1g/vial |
DigiFab | 103910/0 | 8/31/2001 | 40 mg/vial | |
California Department of Public Health | Baby BIG | 125034/0 | 10/23/2003 | 100 mg/vial |
Cangene Corp | HepaGamB | 125035/0 | 1/27/2006 | >312 IU/mL |
HepaGam BT | 125237/0 | 4/6/2007 | >312 IU/mL | |
WinRho SDF Liquid | 103649/5107 | 3/31/2005 | 1,500 IU/mL | |
CNJ-016 | 125109/0 | 5/2/2005 | >50,000 u/15mL | |
Crucell Switzerland LTD License 1841 | Vivotif | 103123/0 | 12/15/1989 | 2-6.8 bil cfu/capsule |
CSL Behring AG | AlbuRx | 102366/0 | 7/23/1976 | 5% |
Cytogam | 103189/0 | 4/17/1990 | 5% | |
Carimune NF, | 102367/0 | 6/7/1984 | 3 g/vial | |
Hizentra | 125350/0 | 3/4/2010 | 20% (1 g/5 mL, 2 g/10 mL, 4 g/20 mL) | |
Privigen | 125201/0 | 7/26/2007 | 10% (2.5 g/25 mL, 5 g/50 mL, 10 g/100 mL, and 20 g/200 mL vials) | |
Rhophylac | 125070/0 | 2/12/2004 | 1,500 IU/syringe | |
CSL Behring GmbH | Berinert | 125287/0 | 10/9/2009 | 500 u/vial |
Humate-P | 103960/0 | 4/11/2000 | 250 IU/vial | |
Corifact | 125385/0 | 2/17/2011 | 1,000-1,600 units/vial | |
RiaSTAP | 125317/0 | 1/16/2009 | 1 g/vial (900 - 1,300 mg) | |
CSL Behring LLC | Albuminar | 103955/0 | 3/17/2000 | 5% |
Zemaira | 125078/0 | 7/8/2003 | 1.0 g/vial | |
Monoclate-P | 103953/0 | 3/17/2000 | 250 IU/vial | |
Mononine | 103957/0 | 3/17/2000 | 500 IU/vial | |
CSL Limited | Afluria | 125254/0 | 9/28/2007 | 15 mcg/0.5 mL |
Dendreon Corporation | Provenge | 125197/0 | 4/29/2010 | 50 million CD54+ cells in 250 mL |
Emergent BioDefense Operations Lansing, Inc. | Biothrax | 103821/0 | 11/12/1998 | 0.5 mL/vial |
Fibrocell Technologies,Inc. License 1818 | LaViv | 125348/0 | 6/21/2011 | 18 mu/1.2 mL |
GTC Biotherapeutics, Inc. | ATryn | 125284/0 | 2/6/2009 | 1750 IU/vial |
Genzyme Biosurgery | Carticel SM Service | 103661/0 | 8/22/1997 | 12 mil/vial |
Genzyme Corp | Thymoglobulin | 103869/0 | 5/19/1999 | 25 mg/vial |
GlaxoSmithKline Biologicals | Infanrix | 103647/0 | 1/29/1997 | 25Lf/10Lf/25mcg/0.5mL |
Kinrix | 125260/0 | 6/24/2008 | 0.5 mL/vial | |
Pediarix | 103907/0 | 12/13/2002 | 0.5 mL/vial | |
Twinrix | 103850/0 | 5/11/2001 | 1 mL/vial | |
Havrix | 103475/0 | 2/22/1995 | 1440 ELISA u/mL | |
Hiberix | 125347/0 | 8/19/2009 | 10 mcg/25 mcg vial | |
Engerix-B | 103239/0 | 8/28/1989 | 10 mcg/0.5 mL vial | |
Cervarix | 125259/0 | 10/16/2009 | 0.5 mL/vial | |
Fluarix | 125127/0 | 8/31/2005 | 45 mcg/0.5 mL | |
Menhibrix | 125363/0 | 6/24/2012 | 0.5 mL/vial | |
Rotarix | 125265/0 | 4/3/2008 | 1 mL/dose | |
Boostrix | 125106/0 | 5/3/2005 | 2.5Lf/5Lf/2.5mcg/8mcg/0.5mL | |
Grifols Biologicals, Inc | Albutein | 102478/0 | 8/15/1978 | 5% |
Alphanate | 102475/0 | 8/15/1978 | 250 IU/vial | |
AlphaNine SD | 103249/0 | 12/31/1990 | 500 IU/vial | |
Profilnine SD | 102476/0 | 7/20/1981 | 500 IU/vial | |
Grifols Therapeutics, Inc. | Plasbumin | 101138/0 | 10/21/1942 | 5% |
Prolastin-C | 103174/0 | 12/2/1987 | 1,000 mg/vial | |
Koate-DVI | 101130/0 | 1/24/1974 | 250 IU/vial | |
Thrombate III | 103196/0 | 12/30/1991 | 500 IU/vial | |
HyperHep B S/D | 101146/0 | 9/23/1977 | 220 IU/mL | |
GammaSTAN S/D | 101134/0 | 1/11/1944 | 16.5% | |
Gamunex-C | 125046/0 | 8/27/2003 | 10% | |
Plasmanate | 101140/0 | 10/2/1958 | 5% | |
HyperRAB S/D | 101144/0 | 6/12/1974 | 150 IU/mL | |
HyperRHO S/D | 101141/0 | 6/11/1971 | 250 IU/vial | |
HyperTET S/D | 101142/0 | 10/17/1957 | 250 u/syringe | |
ID Biomedical Corp of Quebec | FluLaval | 125163/0 | 10/5/2006 | 15 mcg/0.5 mL vial |
Instituto Grifols, SA | Albumin (Human) | 103352/0 | 2/17/1995 | 20% |
Flebogamma | 125077/0 125077/146 | 12/15/2003 7/27/2010 | 5% | |
Intercell AG | Ixiaro | 125280/0 | 3/30/2009 | 0.5 mL/syringe |
JHP Pharmaceuticals LLC | Aplisol | 103782/0 | 4/20/1998 | 5 TU/0.1 mL |
Jubilant | Positive Skin Test Control-Histamine | 103891/0 | 6/2/1999 | 6 mg/mL |
Kamada Ltd. | Glassia | 125325/0 | 7/1/2010 | 1 g/vial |
Kedrion, S.p.A. | Kedbumin | 125384/0 | 6/3/2011 | 50 mL/vial |
Lundbeck, Inc. | Panhematin | 101246/0 | 7/20/1983 | 313 mg/vial |
MassBioLogics | Tetanus and Diphtheria Toxoids Adsorbed | 101322/0 | 7/27/1970 | 0.5 mL/vial |
MedImmune LLC | Flumist | 125020/0 | 6/17/2003 | 10 x 6.5-7.5 TCID |
Flumist Quad | 125020/1668 | 4/5/2011 | 0.2 mL/vial | |
Merck Sharp & Dohme Corp. | Antivenin (Latrodectus mactans) | 101062/0 | 2/13/1936 | nlt 6000 u/vial |
COMVAX | 103623/0 | 10/2/1996 | 7.5 mcg PRP/125 mcg OMPC/5 mcg HBsAg/0.5mL vial | |
PedvaxHIB | 103237/0 | 12/20/1989 | 7.5 mcg/0.5mL | |
VAQTA | 103606/0 | 3/29/1996 | 50 u/mL | |
Recombivax, | 101066/0 | 7/23/1986 | 10 mcg/mL | |
GARDASIL | 125126/0 | 6/8/2006 | 120 mcg HPV 6 L1 Protein mg/0.5 mL/syringe | |
Attenuvax | 101068/0 | 3/21/1963 | nlt 1000 u/0.5 mL vial | |
M-M-R II | 101069/0 | 4/22/1971 | 0.5 mL/vial | |
ProQuad | 125108/0 | 9/6/2005 | 0.5 mL/vial | |
MumpsVax | 101072/0 | 12/28/1967 | 0.5 mL/vial | |
Normal Horse Serum | 101084/0 | 1/2/1959 |
| |
Pneumovax 23 | 101094/0 | 11/21/1977 | 25 mcg/0.5 mL vial | |
RotaTeq | 125122/0 | 2/3/2006 | 2 mL/tube | |
Meruvax II | 101075/0 | 6/9/1969 | nlt 1000 u/0.5 mL vial | |
Varivax | 103552/0 | 3/17/1995 | nlt 1350 pf u/0.5mL | |
Zostavax | 125123/0 | 5/25/2006 | 0.65 mL/vial | |
Novartis Vaccines and Diagnostics GmbH License 1754 | RabAvert | 103334/0 | 10/20/1997 | 2.5 u/vial |
Novartis Vaccines and Diagnostics, Inc. | Agriflu | 125297/0 | 11/27/2009 | .05 mL/syringe |
Menveo | 125300/0 | 2/19/2010 | 0.5 mL/vial | |
Novartis Vaccines and Diagnostics Limited | FluVirin | 103837/0 | 11/3/1998 | 15 mcg/0.5 mL |
Novo Nordisk, Inc. | NovoSeven, NovoSeven RT | 103665/0 | 3/25/1999 | 1 mg/vial |
Nycomed Danmark ApS | TachoSil | 125351/0 | 4/5/2010 | 3.0 cm x 2.5 cm |
Octapharma Pharmazeutika Produktionsges.m.b.H. | Albumin (Human) | 125154/0 | 10/17/2006 | 5% |
Octagam | 125062/0 | 5/21/2004 | 5% | |
Wilate | 125251/22 | 12/20/2010 | 500 IU/vial | |
Organogenesis, Inc. | GINTUIT | 125400/0 | 3/9/2012 | >0.000001 mcg/mL |
OMRIX biopharmaceuticals, Ltd | Evicel | 125010/0 | 3/21/2003 | 1 mL kit |
Evithrom | 125247/0 | 8/27/2007 | 800-1,200 IU/mL solution | |
Organon Teknika Corp LLC | Tice BCG | 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 | RhoGAM | 103777/0 | 4/23/1998 | 50 mcg |
Pharmacia & Upjohn Company | Atgam | 103676/0 | 12/4/1996 | 50 mg/mL |
Rare Disease Therapeutics, Inc. (RDT) License 1860 | Anascorp | 125335/0 | 8/3/2011 | not >120 mg/vial |
Sanofi Pasteur Biologics Co. | ACAM2000 | 125158/0 | 8/31/2007 | 1 – 5 x 10 8 PFU/mL |
Sanofi Pasteur, Inc | Tripedia | 103922/0 | 12/9/1999 | 6.7Lf/5Lf/46.8 mcg/0.5mL |
Diphtheria & Tetanus Toxoids Adsorbed | 103919/0 | 12/9/1999 | 6.6; 5 UNT;Units | |
Fluzone/Fluzone High Dose/Fluzone Intradermal | 103914/0 | 12/9/1999 | 45 mcg/0.5mL | |
Menactra | 125089/0 | 1/14/2005 | 48 mcg/0.5mL | |
Menomune | 103926/0 | 12/9/1999 | 50 mcg/0.5mL | |
Tetanus Toxoid Adsorbed | 103913/0 | 12/9/1999 | 5Lf/0.5mL | |
DECAVAC | 103921/0 | 12/9/1999 | 5Lf/2Lf/0.5mL | |
YF-Vax | 103915/0 | 12/9/1999 | 4.74 pfu/0.5mL | |
Sanofi Pasteur Limited | TheraCys | 103943/0 | 2/24/2000 | 81 mg/vial |
Daptacel | 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 | 125145/0 | 6/20/2008 | 0.5 mL/vial | |
TENIVAC | 103171/0 | 11/3/2003 | 5 Lf/2 Lf/0.5mL | |
Adacel | 125111/0 | 6/10/2005 | T5Lf/d2Lf/PT2.5 mcg/FHA5mcg/PRN 3mcg/FIM5mcg/0.5mL | |
Tubersol | 103941/0 | 2/24/2000 | 5 TU/mL | |
Sanofi Pasteur SA | ActHIB, OmniHIB | 103935/0 | 2/4/2000 | 0.5 mL/vial |
IPOL | 103930/0 | 2/4/2000 | 32/40/8 D AU/0.5mL | |
Imogam, Rabies HT | 103932/0 | 2/4/2000 | 150 IU/vial | |
Imovax Rabies | 103931/0 | 2/4/2000 | (IM) 2.5 IU/mL | |
Typhim Vi | 103936/0 | 2/4/2000 | 25 mcg/0.5mL | |
Teva Women's Health, Inc. | 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 |
ViroPharma Biologics, Inc. | Cinryze | 125267/0 | 10/10/2008 | 500 u/vial |
Wyeth Pharmaceuticals, Inc | ReFacto | 103779/0 | 3/6/2000 | 250 IU/vial |
XYNTHA, XYNTHA SOLOFUSE | 125264/0 125264/492 | 2/21/2008 8/6/2010 | 250 IU/vial | |
BeneFIX | 103677/0 | 2/11/1997 | 250 IU/mL | |
Prevnar | 103905/0 | 2/17/2000 | 0.5 mL/vial | |
Prevnar 13 | 125324/0 | 2/24/2010 | 0.5 mL/syringe | |
ZymoGenetics, Inc. | RECOTHROM | 125248/0 | 1/17/2008 | 5,000 IU/vial |
Center for Biologics Evaluation and Research
Discontinued Products List
Applicant | Proprietary Name / | STN | Potency(s) | Approval Date | Date added to Discontinued list |
Allermed Laboratories, Inc. | Positive Skin Test Control-Histamine | 103317/0 | 1.8 mg/mL | 2/14/1992 | 10/1/2007 |
Spherusol | 125354/0 | 0.1 mL/vial | 7/29/2011 | 9/14/2011 | |
Baxter Healthcare Corp | Iveegam EN | 103133/0 | 500 mg/vial | 2/18/1986 | 9/24/2008 |
Feiba VH | 101447/0 | 5,00 IU/vial | 12/21/1979 | 9/14/2011 | |
Bebulin VH | 103112/0 | 200-1200 u-20ml vial | 8/21/1970 | 9/14/2011 | |
Cangene Corp. | WinRho SDF | 103649/0 | 600, 1,500, 5,000 IU/vial | 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. | Immune Globulin (Human) | 103826/0 | 16.5 pct | 11/12/1998 | 10/1/2007 |
Emergent BioDefense Operations Lansing Inc. | BioRab | 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 | 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 | Influenza A (H1N1) 2009 Monovalent | 125020/1215 | 1 x 10 (6.5-7.5) FFU/0.2mL | 9/15/2009 | 9/24/2010 |
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, Inc | NovoSeven | 103665/0 | 1.2 mg/vial | 3/25/1999 | 9/14/2011 |
Research Foundation for Microbial Disease of Osaka University | JE-Vax | 103376/0 | 12/10/1992 | 1.0 mL/vial | 9/14/2011 |
Sanofi Pasteur, Inc. | Influenza A (H1N1) 2009 Monovalent | 103914/5260 | 15 mcg/0.5 mL | 9/15/2009 | 9/24/2010 |
Influenza Virus Vaccine, H5N1 | 125244/0 | 4/17/2007 | 90 mcg/0.5mL | 9/14/2011 | |
Menomune-A/C | 103925/0 | 12/9/1999 | 50 mcg/0.5mL | 9/14/2011 | |
Sanofi Pasteur Limited | Poliovax | 103940/0 | 2/24/2000 | 0.5mL/vial | 9/14/2011 |
Talecris Biotherapeutics, Inc. |
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Prolastin-C | 103174/0 | 500 mg/vial | 12/2/1987 | 3/23/2011 | |
Wellcome Foundation Limited Wellcome Research Laboratories | Digibind | 103141/0 | 4/22/1986 | 38 mg/vial | 9/14/2011 |
Wyeth Pharmaceuticals, Inc. | Antivenin (Crotalidae) Polyvalent | 101098/0 | 10 mL/vial | 2/8/1954 | 10/1/2007 |
Antivenin (Micrurus fulvius) | 101099/0 | 10 mL/vial | 8/28/1967 | 10/1/2007 |