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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

July 10, 2006 Approval Letter - Fluzone

Our Submission Tracking Number (STN): BL 103914/5125

July 10, 2006

Sanofi Pasteur, Inc.
Attn: 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 United States formulation and label revisions for the 2006-2007 influenza season.

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

Please submit all final printed labeling and implementation information on FDA Form 356h. Please provide an PDF-format electronic copy as well.

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: Final Draft labeling of Package insert, Carton, and Container


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