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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

July 14, 2008 Approval Letter (2) - Fluzone

Our STN: BL 103914/5204

Sanofi Pasteur Inc.
Attention: Gary K Chikami
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 2008-2009 United States formulation.

Please submit all final printed labeling at the time of use and include implementation information on FDA form 356h. Please provide PDF-format electronic copies of these labels. We will include the information contained in the above referenced supplement in your Biologics License Application file.

Sincerely yours,

--signature--

Loris D. McVittie, Ph.D.
Acting Director
Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research

Attachment: Approved Final Draft Labeling

 

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Food and Drug Administration

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