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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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July 14, 2005 Approval Letter (1) - Fluzone

Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448

July 14, 2005

Our STN: BLA 103914/5101

Luc Kuykens, MD, MPH, DTM
Aventis Pasteur Inc.
Discovery Drive
Swiftwater, PA 18370-0187

Dear Dr. Kuykens:

The Supplement to your Biologics License Application for the Influenza Virus Vaccine, to include the 2005-2006 United States formulation, has been approved. This information will be included in your License Application file.

Please submit four copies of final printed labeling at the time of use with completed implementation information.

Sincerely yours,

--- signature ---

Philip R. Krause, M.D.
Acting Director
Division of Viral Products
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research


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