2002 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 in order by date of approval.
Transfer of Therapeutic Products to CDER
| Tradename/ Proper Name |
Indication for Use | STN | Manufacturer/ License Number |
Approval Date |
|---|---|---|---|---|
| Biothrax Anthrax Vaccine Adsorbed |
Manufacturing Change: Hollister-Stier as contract manufacturer for filling |
103821 / 5020 | BioPort Corp 3500 N. Martin Luther King Jr Blvd Lansing, MI 48906 License 1260 |
1/31/2002 |
| Biothrax Anthrax Vaccine Adsorbed |
Labeling Change: Updated product labeling |
103821 / 5015 | BioPort Corp 3500 N. Martin Luther King Jr Blvd Lansing, MI 48906 License 1260 |
1/31/2002 |
| Blood Grouping Reagent Combination Kit | Indication for Use:: Manufacture of a "Monoclonal Rh Phenotype Card" | 103756 / 5001 | Micro Typing Systems, Inc 1295 S.W. 29th Avenue Pompano Beach, FL 33069 License 1177 |
5/14/2002 |
| Fluzone Influenza Virus Vaccine |
New Formulation: Preservative free formulation in a single dose presentation in 0.25 ml syringes for pediatric use and 0.5 ml syringes for adults and children | 103914 / 5030 | Aventis Pasteur Inc Discovery Drive Swiftwater, PA 18370-0187 License 1277 |
9/4/2002 |
| VAQTA Hepatitis A Vaccine Inactivated |
New Dosing Schedule: Extension of the timing of the booster dose in adults from 6 to 18 months | 103606 / 5003 | Merck & Co, Inc P.O. Box 4 Sumneytown Pike West Point, PA 19486-0004 License 0002 |
9/4/2002 |
| Prevnar Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein |
Indication for Use: Immunization of infants and toddlers against otitis media caused by vaccine serotypes | 103905 / 1003 | Lederle Laboratories Division American Cyanamid Co 401 N. Middletown Road License 0017 |
10/1/2002 |
| Dryvax Smallpox Vaccine, Dried, Calf Lymph Type |
Indication for Use: Active immunization against smallpox disease |
101106 / 5015 | Wyeth Laboratories, Inc P.O. Box 304 Wasp & Bittle Streets Marietta, PA 17547 License 0003 |
10/25/2002 |