Product Approval Information - Licensing Action
July 14, 2008
Our STN: BL 103914/5204
Sanofi Pasteur Inc.
Attention: Gary K Chikami
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 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.
Sincerely yours,
/Loris D. McVittie, Ph.D./
Loris D. McVittie, Ph.D.
Acting Director
Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
Attachment: Approved Final Draft Labeling