1999 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 |
|---|---|---|---|
| Immune Globulin Intravenous (Human) | New Indication: For treatment of Kawasaki Disease in conjunction with high dose aspirin (80-100 mg/kg/day in four divided doses) |
Baxter Healthcare Corporation 550 North Brand Blvd Glendale, CA 91203 License 0140 |
01/07/1999 |
|
Chiron RIBA HCV 3.0 SIA Hepatitis C Virus Encoded Antigen (Recombinant/Synthetic) (RIBA) |
New Indication: An improved, more specific, supplemental test to confirm screening test results for antibodies to Hepatitis C Virus in human serum or plasma |
Chiron Corp 4560 Horton Street Emeryville, CA 94608-2916 License 1106 |
02/11/1999 |
| Recombivax Hepatitis B Vaccine |
Manufacturing Change: Preservative-free pediatric / adolescent product |
Merck & Co, Inc P.O. Box 4 Summneytown Pike West Point, PA 19486 License 0002 |
08/27/1999 |
| Recombivax Hepatitis B Vaccine |
Labeling Change: Addition of two doses of the 10 mcg formulation (1.0 mL) administered at 0 and 4 to 6 months as an alternate regimen for the routine vaccination of healthy adolescents 11 to 15 years of age |
Merck & Co, Inc P.O. Box 4 Summneytown Pike West Point, PA 19486 License 0002 |
09/23/1999 |
| TheraCys BCG Live |
New Indication: Prophylaxis of primary and recurrent Ta and/or T1 papillary tumors following transurethral resection (TURB) |
Connaught Laboratories Limited 1755 Steeles Avenue, West North York, Ontario, M2R 3T4 CANADA License 0073 |
11/08/1999 |
| Genetic Systems HbsAg Confirmatory Assay 2.0 Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal) Enzyme-Linked Immunosorbent Assay (ELISA) |
Improved Test: Allows for testing of blood from an already deceased potential transplant donor |
Genetic Systems Corporation 6565 185th Avenue NE Redmond, WA 98052-5039 License 0978 |
12/28/1999 |