1997 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 |
|---|---|---|---|
| Venoglobulin-I or Venoglobulin-S Immune Globulin Intravenous (Human) |
New Indication: Treatment of Kawasaki Disease in conjunction with high dose aspirin (100 mg/kg/day) |
Alpha Therapeutic Corp 5555 Valley Blvd Los Angeles, CA 90032 License 0744 |
1/10/1997 |
| Havrix Hepatitis A Vaccine Inactivated |
New Indication: Prevention of Hepatitis A in patients with chronic liver disease |
SmithKline Beecham 89, rue de l'Institut 1330 Rixensart BELGIUM License 1090 |
6/25/1997 |