Product Approval Information - Licensing Action
Our STN: BL 103914/5167
July 13, 2007
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 the 2007-2008 United States formulation.
Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h. Please provide a PDF-format electronic copy.
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