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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

June 27, 2011 Approval Letter (103914/5449) - Fluzone

Our STN:   BL 103914/5449

 
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 2011-2012 United States formulation.
 
Please submit all final printed labeling at the time of use and include implementation information on FDA form 356h. Please provide content of labeling in Structured Product Labeling format. Please provide carton and container labeling in Structured Product Labeling format.
 
We will include the information contained in the above referenced supplement in your Biologics License Application file.
 
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: Approved Final Draft Labeling