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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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  • Vaccines

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    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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