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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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1999 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
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