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July 14, 2008 Approval Letter (1) - Fluzone
Our STN: BL 103914/5157
Sanofi Pasteur, Inc.
Attention: Gary Chikami, M.D
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.
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