Vaccines, Blood & Biologics

July 14, 2008 Approval Letter (2) - Fluzone

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,

--signature--

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

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
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