2000 Biological License Application Approvals
This list reflects information regarding the applications as of the approval date. It is not updated with regard to applicant or application status changes. The applications 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 |
|---|---|---|---|---|
| Prevnar Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein) |
Immunization of infants 2, 4, 6 and 12-15 months of age to prevent invasive pneumococcal disease | Lederle Laboratories Division American Cyanamid Company 401 N. Middletown Road Pearl River, NY 10965 License 0017 |
2/17/2000 | |
| ReFacto Antihemophilic Factor (Recombinant) |
Control and prevention of hemorrhagic episodes and for short-term routine and surgical prophylaxis in patients with hemophilia A | Genetics Institute, Inc One Burtt Road Andiver, MA 01810-5901 License 1163 |
3/6/2000 | |
| PACIS BCG, Live |
Treatment of carcinoma-in-situ (CIS) in the absence of associated invasive cancer of the bladder | BioChem Pharma Inc 2323 Parc Technologique Blvd Sainte-Foy, Quebec Canada License 1283 |
3/9/2000 | |
| Plasma | Transfusion | Rex Hospital, Inc 4420 Lake Boone Trail Raleigh, NC License 0748 |
3/10/2000 | |
| Platelets | Transfusion | Rex Hospital, Inc 4420 Lake Boone Trail Raleigh, NC License 0748 |
3/10/2000 | |
| ID Micro Typing Systems Anti-A (Murine Monoclonal) |
In vitro test/antigen detection; monoclonal antibody, derived from the BIRMA-1 cell line, in MTS Gel Cards under a shared manufacturing agreement with Serologicals Ltd | 103787 / 0 | Micro Typing Systems, Inc 1295 S.W. 29th Avenue Pompano Beach, Fl License 1177 |
9/21/2000 |
| ID Micro Typing Systems Anti-B (Murine Monoclonal) |
In vitro test/antigen detection; monoclonal antibody, derived from the LB-2 cell line, in MTS Gel Cards under a shared manufacturing agreement with Serologicals Ltd | 103789 / 0 | Micro Typing Systems, Inc 1295 S.W. 29th Avenue Pompano Beach, Fl License 1177 |
9/21/2000 |
| ID Micro Typing Systems Anti-A and B (Murine Monoclonal); Anti-A,B (Murine Monoclonal) |
In vitro test/antigen detection; monoclonal antibody, derived from the ES-15 & ES-4 cell lines, in MTS Gel Cards under a shared manufacturing agreement with Serologicals Ltd | 103790 / 0 | Micro Typing Systems, Inc 1295 S.W. 29th Avenue Pompano Beach, Fl License 1177 |
9/21/2000 |
| ID Micro Typing Systems Anti-D (Human Monoclonal) (IgM) |
In vitro test/antigen detection; monoclonal antibody, derived from the MS-201 cell line, in MTS Gel Cards under a shared manufacturing agreement with Serologicals Ltd | 103791 / 0 | Micro Typing Systems, Inc 1295 S.W. 29th Avenue Pompano Beach, Fl License 1177 |
9/21/2000 |
| Crofab Crotalidae Polyvalent Immune Fab (Ovine) |
Treatment of minimal and moderate North American Crotalidae envenomation | 103788 / 0 | Protherics, Inc (a wholly-owned subsidiary of Protherics PLC) 1207 17 th Avenue S, Suite 103 Nashville, TN 37212 License 1575 |
10/2/2000 |