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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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1997 Biological License Application Supplement 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.


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