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July 14, 2008 Approval Letter (2) - Fluzone
Our STN: BL 103914/5204
Sanofi Pasteur Inc.
Attention: Gary K Chikami
Swiftwater, PA 18370
Dear Dr. Chikami:
We have approved your request to supplement your Biologics License Application for Influenza Virus Vaccine, to include the 2008-2009 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.
Loris D. McVittie, Ph.D.
Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
Attachment: Approved Final Draft Labeling