Vaccines, Blood & Biologics

July 10, 2009 Approval Letter - Fluzone

July 10, 2009

Our STN:   BL 103914/5249

Sanofi Pasteur Inc.
Attention:  Joseph H. Quinn
Discovery Drive
Swiftwater, PA  19370

Dear Mr. Quinn:

We have approved your request to supplement your biologics license application for Influenza Virus Vaccine, Fluzone®, to include the 2009-2010 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,


Jerry P. Weir, Ph.D.
Division of Viral Products
Office of Vaccines  Research and Review
Center for Biologics  Evaluation and Research

Attachment: Approved Final Draft Labeling

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002

Page Last Updated: 02/12/2010
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.