1998 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 | Manufacturer/ License No. |
Approval Date |
|---|---|---|---|
| Cambridge Biotech HIV-1 (Western Blot) Human Immunodeficiency Virus Type 1 (Western Blot) |
New Indication: For urine specimen testing |
Cambridge Biotech Corp 1500 E. Gude Drive Rockville, MD 20850 License 1063 |
05/28/1998 |
| Genetic Systems rLAV Human Immunodeficiency Virus Type 1 |
New HIV-1 enzyme immunoassay (EIA) which contains a combination of HIV-1 viral lysate and HIV-1 recombinant antigen | Genetic Systems Corp 6565 185th Avenue, NE Redmond, WA 98052-5039 License 0978 |
06/29/1998 |
| Engerix-B Hepatitis B Vaccine (Recombinant) |
New/Expanded Indication: For use in individuals (adults) with chronic Hepatitis C infection |
SmithKline Beecham Biologicals Rue de l'Institut 89 B-1330 Rixensart BELGIUM License 1090 |
07/07/1998 |
| TICE BCG BCG Live |
Expanded Indication: For intravesical instillation to include adjunct treatment of stage Ta or T1 papillary tumors of the bladder |
Organon Teknika Corporation 100 Akzo Avenue Durham, NC 27712 License 0956 |
08/21/1998 |
| Mycobax BCG Vaccine |
Expanded Indication: For immunization against tuberculosis |
Connaught Laboratories Ltd 1755 Steeles Avenue, West North York, Ontario Canada MR2 3T4 License 0073 |
10/09/1998 |
| Genetic Systems HIV-1 Western Blot Human Immunodeficiency Virus Type 1 (Western Blot) |
New Indication: New HIV-1 Western Blot assay intended for use with persons of unknown risk as more specific test on human serum, plasma, or dried blood specimens found to be repeatedly reactive using screening procedure |
Genetic Systems Corporation 6565 185th Avenue NE Redmond, WA 98052-5039 License 0978 |
11/23/1998 |
| Cytomegalovirus Immune Globulin Intravenous (Human) | New Indication: Prophylaxis of cytomegalovirus disease associated with transplantation of kidney, lung, liver pancreas and heart |
Massachusetts Public Health Biologic Laboratories 305 South Street Boston, MA 02130-3597 License 0064 |
12/04/1998 |