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Vaccines, Blood & Biologics

July 17, 2009 Approval Letter - FluMist 2009/2010 Formulation

July 17, 2009

Our STN: BL 125020/1163


MedImmune, LLC
Attention: Nancy R. Kavanaugh, Ph.D.
One MedImmune Way
Gaithersburg, MD 20878

Dear Dr. Kavanaugh:

We have approved your request to supplement your biologics license application for Influenza Virus Vaccine Live, Intranasal (FluMist®), to include the 2009-2010 United States formulation. 

Please note that the use of updated labeling for marketing your product is being approved under STN 125020/1086.  We will include the information contained in the above-referenced supplement in your Biologics License Application file.

Sincerely yours





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



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