2005 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.
Complete list of currently licensed products and establishments
Transfer of Therapeutic Products to CDER
Note: Approvals are listed with the most recent action at the top.
| Tradename/ Proper Name |
Indication for Use | STN | Manufacturer/ License No. |
Approval Date |
| Boostrix Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed |
Package Insert Revision: Include addition of clinical safety information to the package insert |
125106 / 10 | GlaxoSmithKline Biologicals Rue de l'Institut 89 B1330 Rixensart Belgium License 1617 |
12/29/2005 |
| Menactra Meningococcal Groups (A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine |
Package Insert Revision | 125089 / 47 | Aventis Pasteur, Inc Discovery Drive Swiftwater, PA 18370-0187 License 1277 |
10/21/2005 |
| Havrix Hepatitis A Vaccine, Inactivated |
Package Insert Revision: To support lowering the age indication for Havrix from two years to 12 months of age |
103475 / 5090 | GlaxoSmithKline Biologicals Rue de l'Institut 89 B1330 Rixensart Belgium License 1617 |
10/17/2005 |
| Dryvax Smallpox Vaccine, Dried, Calf Lymph Type |
Package Insert Revision: Include a new Black Box warning for cardiac events and other safety information |
101106 / 5067 | Wyeth Pharmaceuticals, Inc 401 North Middleton Road Pearl River, NY 10965-8668 License 0003 |
10/11/2005 |
| Tetanus Toxoid Adsorbed | New Dosage Form: Addition of a preservative free single dose vial formulation |
103913 / 5047 | Aventis Pasteur Inc Discovery Drive Swiftwater, PA 18370-0187 License 1277 |
9/23/2005 |
| Fluvirin Influenza Virus Vaccine |
New Formulation: 2005-2006 United States formulation |
103837 / 5066 | Chiron Vaccines Ltd Gaskill Road L249GR Speke, Liverpool UK License 1720 |
9/14/2005 |
| Aralast Alpha-1-Proteinase Inhibitor (Human) |
Manufacturing Change: ---- Fr.IV1+4 paste as an alternate starting material |
125039 / 69 | Baxter Healthcare Corp One Baxter Way Westlake Village, CA 91362 License 0140 |
9/9/2005 |
| FluMist Influenza Virus Vaccine Live, Intranasal |
New Formulation: 2005-2006 United States formulation |
125020 / 69 | MedImmune Vaccines, Inc 297 N. Bernardo Ave Mountain View, CA 94043 License 1652 |
8/18/2005 |
| NovoSeven Coagulation Factor VIIa (Recombinant) |
Expanded Indication for Use: For use in surgical procedures in hemophilia A or B patients with inhibitors to Factor VIII or Factor IX |
103665 / 5057 | Novo Nordisk Pharmaceuticals, Inc 100 College Road West Princeton, NJ 08540 License 1261 |
8/12/2005 |
| VAQTA Hepatitis A Vaccine, Inactivated |
Expanded Indication for Use: Lowering the age indication for VAQTA from two years to 12 months of age |
103606 / 5049 | Merck & Co, Inc P.O. Box 4 Sumneytown Pike West Point, PA 19486 License 0002 |
8/11/2005 |
| COBAS AmpliScreen HBV Test Hepatitis B Virus (Hepatitis B Virus/Polymerase Chain Reaction/Blood Cell Derived) |
Expanded Indication for Use: Testing for Hepatitis B Virus DNA in post-mortem cadaveric (non-heart-beating) donors using an individual testing format |
125090 / 3 | Roche Molecular Systems, Inc 4300 Hacienda Drive Pleasanton, California 94566-0900 License 1636 |
8/2/2005 |
| Reagent Red Blood Cells | Manufacturing Change: Include modification to the manufacturing process and creation of new Reverse-Cyte A1 and B cells and Search-Cyte Pool, Duo and Trio Reagent Red Blood Cell products for use on the TANGO Automated Blood Bank Analyzer |
103898 / 5019 | Medion Diagnostics GmbH Bonnstrasse 9 CH-3186 Dudingen Switzerland License 1616 |
7/26/2005 |
| Fluzone Influenza Virus Vaccine |
New Formulation: Include a preservative free single dose presentation in a unit dose vial |
103914 / 5097 | Aventis Pasteur Inc Discovery Drive Swiftwater, PA 18370-0187 License 1277 |
7/14/2005 |
| Fluzone Influenza Virus Vaccine |
New Formulation Include the 2005-2006 United States formulation |
103914 / 5101 | Aventis Pasteur Inc Discovery Drive Swiftwater, PA 18370-0187 License 1277 |
7/14/2005 |
| NovoSeven Coagulation Factor VIIa (Recombinant) |
New Indication for Use: Treatment of bleeding episodes in patients with Factor VII Deficiency |
103665 / 5052 | Novo Nordisk Pharmaceuticals, Inc 100 College Road West Princeton, NJ 08540 License 1261 |
7/11/2005 |
| Diphtheria and Tetanus Toxoids Adsorbed Combined Bulk (For Further Manufacturing Use) | For further manufacture to Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed under a shared manufacturing arrangement with GlaxoSmithKline Biologicals | 103648 / 5046 | Chiron Behring GmbH & Co P.O. Box 1630 35006 Marburg Germany License 1222 |
5/3/2005 |
| Biothrax Anthrax Vaccine Adsorbed |
Extension of dating to 36 months | 103821 / 5070 | BioPort Corp 3500 N. Martin Luther King, Jr. Blvd Lansing, MI 48906 License 1260 |
4/27/2005 |
| Varivax Varicella Virus Vaccine Live |
Optional second dose for children 12 months to 12 years of age | 103552 / 5079 | Merck & Co, Inc Sumneytown Pike P.O. Box 4 West Point, PA 19486 License 0002 |
4/5/2005 |
| WinRho SDF Liquid Rho(D) Immune Globulin Intravenous (Human) |
New Formulation: Provide for a liquid formulation |
103649 / 5107 | Cangene Corp 104 Chancellor Matheson Rd Winnepeg, Manitoba Canada R3T5Y3 License 1201 |
3/31/2005 |
| FluMist Influenza Virus Vaccine Live, Intranasal |
Package Insert Revision Changes to the previously approved 2004-2005 US labeling (package insert) |
125020 / 44 | MedImmune Vaccines, Inc 297 N. Bernardo Ave Mountain View, CA License 1652 |
3/18/2005 |
| COBAS AmpliScreen HCV Test, version 2.0 Hepatitis C Virus (Hepatitis C Virus / Polymerase Chain Reaction / Blood Cell Derived) |
Expanded Indication for Use: Testing of individual cadaveric specimens (obtained from non-heart-beating donors) |
125045 / 5015 | Roche Molecular Systems 4300 Hacienda Drive PO Box 9002 Pleasanton, CA 94566-0900 License 1636 |
3/9/2005 |
| COBAS AmpliScreen HIV-1 Test, version 1.5 Human Immunodeficiency Virus Type 1 (HIV-1 / Polymerase Chain Reaction) |
Expanded Indication for Use Testing of individual cadaveric specimens (obtained from non-heart-beating donors) |
125059 / 13 | Roche Molecular Systems 4300 Hacienda Drive PO Box 9002 Pleasanton, CA 94566-0900 License 1636 |
3/9/2005 |
