2000 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 HIV-1 / HIV-2 Peptide EIA Human Immunodeficiency Virus Type 1 and 2 (Synthetic Peptide) |
Expanded Indication: Testing of cadaveric serum samples |
Genetic Systems Corp 6565 185th Avenue NE Redmond, WA 98052-5039 License 0978 |
2/9/2000 | |
| Carticel SM Service Autologous Cultured Chondrocytes |
Narrow the indication to second line therapy, for use in patients who have had an inadequate response to a prior arthroscopic or other surgical repair procedure | Genzyme Tissue Repair 64 Sidney Street Cambridge, MA 02139-4136 License 1233 |
3/2/2000 | |
| Kogenate FS Antihemophilic Factor (Recombinant) |
New product formulation | Bayer Corp 800 Dwight Way P.O.Box 1986 Berkeley, CA License 0008 |
6/26/2000 | |
| Anti-D, Anti-A, Anti-B, Anti-A,B Monoclonal Antibodies | First approval for monoclonal antibodies to be used in a gel card; for further manufacture in a shared agreement with Micro Typing Systems, Inc | 103856 / 1001 | Serologicals LTD Fleming Road Livingston, United Kingdom License 1270 |
9/21/2000 |
| ID Micro Typing Systems A/B/D Monoclonal Grouping Combination Gel Card |
First approval for production of a monoclonal grouping combination gel card | 103756 / 1005 | Micro Typing Systems, Inc 1295 S.W. 29th Avenue Pompano Beach, Fl License 1177 |
9/27/2000 |