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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

May 6, 2009 Approval Letter - Fluzone

May 6, 2009

Our STN: BL 103914/5232

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 to include a new bulk facility, the New Influenza Vaccine Manufacturing Facility (NIVMF), Building (b)(4), for the manufacture of influenza monovalent concentrates for Influenza Virus Vaccine at a scale of -(b)(4)- eggs per batch, and a Comparability Protocol for use of the NIVMF as a multi-product facility, at your Swiftwater, Pennsylvania location.

Under 21 CFR 601.12(e), approval of a comparability protocol may justify a reduced reporting category for a particular change. You should report information confirming that the change meets the requirements specified in your approved comparability protocol as a “Supplement – Changes Being Effected in 30 Days” (21 CFR 601.12(c)). You should include the information described in 21 CFR 601.12 (b)(3) in this supplement. Although you may distribute the product made using this change 30 days after FDA receives the supplement, continued use of the change will be subject to our final approval of the supplement.

We acknowledge your written commitments as described in your amendment to BLA ( STN 103914/5232/5001) of March 27, 2009 as outlined below:

Post-marketing Studies not subject to reporting requirements of 21 CFR 601.70:

------------------------------------------(b)(4)-----------------------------------------------------------------------------------------------------------------(b)(4)--------------------------------------------.-------------------------------------------------------------------(b)(4)-----------------------------------------------.---------------------------------------------------------------(b)(4)-----------------------------------.

We will include information contained in the above-referenced supplement in your biologics license application file.

Sincerely yours

/Mary A. Malarkey /

Mary A. Malarkey 
Director 
Office of Compliance and Biologics Quality 
Center for Biologics Evaluation and Research