2003 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 |
|---|---|---|---|---|
| Genetic Systems HBsAg EIA 3.0
Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal) Enzyme-Linked Immunosorbent Assay (ELISA) (Antibody to HBsAG/Enzyme Immuno Assay (EIA)) |
Indication for Use: Detection of Hepatitis B Surface Antigen (HBsAg) in human serum or plasma, and also in cadaveric serum specimens |
103590 / 5008 | Bio-Rad Laboratories 6565 185th Avenue NE Redmond, WA 98052 License 1109 |
1/23/2003 |
| Diphtheria and Tetanus Toxoids Adsorbed (DT), for Pediatric Use | New Formulation: Addition of a preservative-free, single dose vial presentation |
103919 / 5018 | Aventis Pasteur, Inc Discovery Drive Swiftwater, PA 18370 License 1277 |
1/29/2003 |
| Dryvax Smallpox Vaccine, Dried, Calf Lymph Type |
Package Insert Revision: Include new safety information for the recent reports of cardiac events and updated storage period for the vaccine after reconstitution from 15 days to 90 days |
101106 / 5030 | Wyeth Laboratories, Inc Wasp & Biddle Streets P.O. Box 304 Marietta, PA 17547 License 0003 |
6/26/2003 |
| Infanrix Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed |
Expanded Indication: Include a fifth dose at 4-6 years of age after 4 prior doses of Infanrix |
103647 / 5001 | GlaxoSmithKline Biologicals 89, Rue de l'Institut 1330 Rixensart Belgium License 1090 |
7/7/2003 |
| COBAS AmpliScreen HIV-1 Test, version 1.5 Human Immunodeficiency Virus Type 1 (HIV-1/Polymerase Chain Reaction) |
Expanded indication for use: Testing for Source Plasma donors in a mini-pool format of up to 96 donations with single unit resolution testing; and testing individual plasma samples from other living donors and organ donors (when specimens are obtained while the donor's heart is still beating) |
125059 / 6 | Roche Molecular Systems 4300 Hacienda Drive PO Box 9002 Pleasanton, CA 94566-0900 License 1636 |
12/19/2003 |