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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

July 13, 2007 Approval Letter - Fluzone

Our STN: BL 103914/5167

July 13, 2007

Sanofi Pasteur, Inc.
Attention: Gary Chikami, M.D.
Discovery Drive
Swiftwater, PA 18370

Dear Dr. Chikami:

We have approved your request to supplement your Biologics License Application for Influenza Virus Vaccine, to include the 2007-2008 United States formulation.

Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h. Please provide a PDF-format electronic copy.

We will include the information contained in the above referenced supplement in your Biologics License Application file.

Sincerely yours

Jerry P. Weir, Ph.D.
Director
Division of Viral Products
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research

Attachment: Approved Final Draft Labeling


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