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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

July 24, 2007 Approval Letter - Fluarix

Our STN: BL 125127/229

July 24, 2007

GlaxoSmithKline Biologicals
Attn: Mary Beth Ebert, M.S.
2301 Renaissance Boulevard
Building 510, P.O. Box 61540
King of Prussia, PA 19406-2772

Dear Ms. Ebert:

We have approved your request to supplement your biologics license application for Influenza Virus Vaccine, Fluarix®, to include the 2007-2008 United States formulation. We will include information contained in the above-referenced supplement in your biologics license application file.

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

Sincerely yours,

--- signature ---

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


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