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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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July 15, 2009 Approval Letter - Fluarix

July 15, 2009

GlaxoSmithKline Biologicals
Attention: 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 2009-2010 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 information contained in the above-referenced supplement in your biologics license application file.

Sincerely yours,

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