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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

December 23, 2004 Approval Letter - Fluzone

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448

December 23, 2004

Submission Tracking Number (STN): BL 103914/5082

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 a single dose formulation without thimerosal for the 0.25 mL and 0.5 mL syringes, has been approved. Please note that we are also approving your container and carton labeling for 2005-2006 season with respect to changes due to elimination of thimerosal from the manufacturing process. Please also note that this approval does not include the package insert for 2005-2006 season as submitted with this supplement. The revised package insert will be reviewed along with the other labeling changes that are routinely submitted due to annual formulation changes and changes to the recommendation regarding vaccine use by ACIP.

This information will be included in your License Application file. It is recommended that a copy of this letter be available for review at the time of FDA inspections.

Sincerely yours,

--- signature ---

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


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