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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

August 5, 2008 Approval Letter - Fluarix

Our STN: 125127/294

August 4, 2008

GlaxoSmithKline Biologicals
Attn: Ms. Mary Beth Ebert
2301 Renaissance Boulevard
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 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 Weir/

Jerry 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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