Vaccines, Blood & Biologics
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2010 Biological License Application Supplement Noteworthy Approvals
This list reflects information regarding the supplements as of the approval date. It is not updated with regard to applicant or application status changes. The supplements are listed by date of approval, with the most recent action at the top.
| Tradename/ Proper Name | Indication for Use | STN | Manufacturer/ License No. | Approval Date |
|---|---|---|---|---|
| GARDASIL Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant | Prevention of anal intraepithelial neoplasia (AIN) grades 1, 2, and 3 caused by HPV types included in the vaccine, in males and females 9 through 26 years of age, and the prevention of anal cancer caused by HPV types 16 and 18 in males and females 9 through 26 years of age | 125126/1895 | Merck Sharp & Dohme Corp. P.O. Box 4 770 Sumneytown Pike West Point, PA 19486 License 0002 | 12/22/2010 |
| Agriflu Influenza Vaccine | To include data from the confirmatory clinical studies to verify and describe the clinical benefit | 125297/1 | Novartis Vaccines and Diagnostics, Inc. 4560 Horton St Emeryville, CA 94608-2916 License 1751 | 10/29/2010 |
| Ixiaro Japanese Encephalitis Virus Vaccine Inactivated | To include long term immuno-genicity data in the package insert and the use of a booster dose following the primary series | 125280/19 | Intercell AG Campus Vienna Biocenter 2 1030 Vienna Austria License 1790 | 10/14/2010 |
| Gamunex Immune Globulin Intravenous (Human), 10%, Caprylate/Chromatography Purified (IGIV-C) | New route of administration: subcutaneous, for the treatment of Primary Humoral Immunodeficiency | 125046/619 | Talecris Biotherapeutics, Inc. 8368 U.S. 70 W Clayton, NC 27520 License 1716 | 10/13/2010 |
| AFLURIA Influenza Virus Vaccine | 2010-2011 United States formulation | 125254/181 | CSL Limited 45 Poplar Road Parkville, Victoria 3052 Australia License 1764 | 7/30/2010 |
| FLUARIX Influenza Virus Vaccine | 2010-2011 United States formulation | 125127/432 | GlaxoSmithKline Biologicals Rue de l'Institut 89 B1330 Rixensart Belgium License 1617 | 7/28/2010 |
| Agriflu Influenza Vaccine | 2010-2011 United States formulation | 125297/3 | Novartis Vaccines and Diagnostics, Inc. 4560 Horton St Emeryville, CA 94608-2916 License 1751 | 7/28/2010 |
| FluVirin Influenza Virus Vaccine | 2010-2011 United States formulation | 103837/5543 | Novartis Vaccines and Diagnostics Limited Gaskill Road Speke, Liverpool L24 9GR License 1750 | 7/28/2010 |
Flebogamma
| Additional strength, 10% immunoglobulin concentration | 125077/146 | Instituto Grifols, S.A. | 7/27/2010 |
| FluLaval Influenza Virus Vaccine | 2010-2011 United States formulation | 125163/172 | ID Biomedical Corporation of Quebec 525 Cartier Blvd, West Laval, Quebec 87V 3S8 Canada License 1739 | 7/23/2010 |
| Fluzone Influenza Virus Vaccine | 2010-2011 United States formulation | 103914/5326 | Sanofi Pasteur Inc. Discovery Drive Swiftwater, PA 18370-0187 License 1725 | 7/23/2010 |
| Flumist Influenza Virus Vaccine Live, Intranasal | 2010-2011 United States formulation | 125020/1436 | MedImmune, LLC 297 North Bernardo Ave Mountain View, CA 94043 License 1799 | 7/22/2010 |
| GARDASIL Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine | For concomitant administration with Menactra® and ADACEL® | 125126/1516 | Merck & Co., Inc. P.O. Box 4 770 Sumneytown Pike West Point, PA 19486 License 0002 | 6/9/2010 |
| VAQTA Hepatitis A Vaccine Inactivated | Concomitant administration with Measles, Mumps, Rubella, and Varicella Vaccine, Live, (ProQuad®) and pneumococcal conjugate vaccine (Prevnar®); A statement in Section 14.4 of the package insert on duration of immune response to extend the duration of immunity out to 10 years post-vaccination; and revisions to the labeling to comply with the Physicians Labeling Rule. | 103606/5374 | Merck & Co., Inc.
| 3/30/2010 |
Pediarix
| Update package insert to include results from a postmarketing safety surveillance study that evaluated the risk of all seizures (with or without fever), and the risk of medically attended fever following Pediarix® administration in a cohort of infants at a U.S. Health Maintenance Organization, and to comply with the labeling requirements of the Physicians Labeling Rule. | 103907/5227 | GlaxoSmithKline Biologicals
| 3/5/2010 |
| CroFab Crotalidae Polyvalent Immune Fab (Ovine) | Treatment for severe envenomation.
| 103788/5144 | Protherics Inc. a wholly-owned subsidiary of Protherics PLC, c/o Therapeutic Antibodies, Inc. 5214 Maryland Way, Suite 405 Brentwood, TN 37027 License 1575 | 3/4/2010 |
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