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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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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.
Director
Division of Viral Products
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research