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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 (1) - Fluzone

Our STN: BL 103914/5157

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 revisions to the package insert to comply with Physician's Labeling Rule guidelines.

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