Vaccines, Blood & Biologics
July 10, 2006 Approval Letter - Fluzone
Our Submission Tracking Number (STN): BL 103914/5125
July 10, 2006
Sanofi Pasteur, Inc.
Attn: 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 the United States formulation and label revisions for the 2006-2007 influenza season.
We will include the information contained in the above referenced supplement in your Biologics License Application file.
Please submit all final printed labeling and implementation information on FDA Form 356h. Please provide an PDF-format electronic copy as well.
Jerry P. Weir, Ph.D.
Division of Viral Products
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
Attachment: Final Draft labeling of Package insert, Carton, and Container