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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

July 14, 2005 Approval Letter (2) - 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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