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Vaccines, Blood & Biologics
July 14, 2005 Approval Letter (New Dosage Form) - Fluzone
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
July 14, 2005
Our STN: BLA 103914/5097
Luc Kuykens, MD, MPH, DTM
Aventis Pasteur Inc.
Discovery Drive
Swiftwater, PA 18370-0187
Dear Dr. Kuykens:
The Supplement to your Biologics License Application for the Influenza Virus Vaccine, to include a preservative free single dose presentation in a unit dose vial, has been approved.
This information will be included in your License Application file.
Sincerely yours,
--- signature ---
Philip R. Krause, M.D.
Acting Director
Division of Viral Products
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
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