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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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2003 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 STN Manufacturer/
License Number
Approval Date
Genetic Systems HBsAg EIA 3.0
Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal) Enzyme-Linked Immunosorbent Assay (ELISA) (Antibody to HBsAG/Enzyme Immuno Assay (EIA))
Indication for Use:
Detection of Hepatitis B Surface Antigen (HBsAg) in human serum or plasma, and also in cadaveric serum specimens
103590/5008 Bio-Rad Laboratories
6565 185th Avenue NE
Redmond, WA 98052
License 1109
1/23/2003
Diphtheria and Tetanus Toxoids Adsorbed (DT), for Pediatric Use New Formulation:
Addition of a preservative-free, single dose vial presentation
103919/5018 Aventis Pasteur, Inc
Discovery Drive
Swiftwater, PA 18370
License 1277
1/29/2003
Dryvax
Smallpox Vaccine, Dried, Calf Lymph Type
Package Insert Revision:
Include new safety information for the recent reports of cardiac events and updated storage period for the vaccine after reconstitution from 15 days to 90 days
101106/5030 Wyeth Laboratories, Inc
Wasp & Biddle Streets
P.O. Box 304
Marietta, PA 17547
License 0003
6/26/2003
Infanrix
Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed
Expanded Indication:
Include a fifth dose at 4-6 years of age after 4 prior doses of Infanrix
103647/5001 GlaxoSmithKline Biologicals
89, Rue de l'Institut
1330 Rixensart
Belgium
License 1090
7/7/2003
COBAS AmpliScreen HIV-1 Test, version 1.5
Human Immunodeficiency Virus Type 1 (HIV-1/Polymerase Chain Reaction)
Expanded indication for use:
Testing for Source Plasma donors in a mini-pool format of up to 96 donations with single unit resolution testing; and testing individual plasma samples from other living donors and organ donors (when specimens are obtained while the donor's heart is still beating)
125059/6 Roche Molecular Systems
4300 Hacienda Drive
PO Box 9002
Pleasanton, CA 94566-0900
License 1636
12/19/2003