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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

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July 30, 2008 Approval Letter - Afluria

Our STN: BL 125254/74

CSL Biotherapies
Attention: Paul R. Hartmann
1020 First Avenue
P.O. Box 60446
King of Prussia , PA 19406-0446

Dear Mr. Hartmann:

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,

/Jerry P. Weir/

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

Attachment: Approved Final Draft Labeling


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