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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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2002 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
Biothrax
Anthrax Vaccine Adsorbed
Manufacturing Change:
Hollister-Stier as contract manufacturer for filling
103821/5020 BioPort Corp
3500 N. Martin Luther King Jr Blvd
Lansing, MI 48906
License 1260
1/31/2002
Biothrax
Anthrax Vaccine Adsorbed
Labeling Change:
Updated product labeling
103821/5015 BioPort Corp
3500 N. Martin Luther King Jr Blvd
Lansing, MI 48906
License 1260
1/31/2002
Blood Grouping Reagent Combination Kit Indication for Use:: Manufacture of a "Monoclonal Rh Phenotype Card" 103756/5001 Micro Typing Systems, Inc
1295 S.W. 29th Avenue
Pompano Beach, FL 33069
License 1177
5/14/2002
Fluzone
Influenza Virus Vaccine
New Formulation: Preservative free formulation in a single dose presentation in 0.25 ml syringes for pediatric use and 0.5 ml syringes for adults and children 103914/5030 Aventis Pasteur Inc
Discovery Drive
Swiftwater, PA 18370-0187
License 1277
9/4/2002
VAQTA
Hepatitis A Vaccine Inactivated
New Dosing Schedule: Extension of the timing of the booster dose in adults from 6 to 18 months 103606/5003 Merck & Co, Inc
P.O. Box 4
Sumneytown Pike
West Point, PA 19486-0004
License 0002
9/4/2002
Prevnar
Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein
Indication for Use: Immunization of infants and toddlers against otitis media caused by vaccine serotypes 103905/1003 Lederle Laboratories Division
American Cyanamid Co
401 N. Middletown Road
License 0017
10/1/2002
Dryvax
Smallpox Vaccine, Dried, Calf Lymph Type
Indication for Use:
Active immunization against smallpox disease
101106/5015 Wyeth Laboratories, Inc
P.O. Box 304
Wasp & Bittle Streets
Marietta, PA 17547
License 0003
10/25/2002