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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

July 10, 2009 Approval Letter - Fluzone

July 10, 2009

Our STN:   BL 103914/5249

Sanofi Pasteur Inc.
Attention:  Joseph H. Quinn
Discovery Drive
Swiftwater, PA  19370

Dear Mr. Quinn:

We have approved your request to supplement your biologics license application for Influenza Virus Vaccine, Fluzone®, to include the 2009-2010 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--

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

 

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

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Silver Spring, MD 20993-0002