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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

July 25, 2008 Approval Letter - Influenza Virus Vaccine Live, Intranasal

Our Submission Tracking Number (STN): BL 125020/794

MedImmune Vaccines, Inc.
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 2008-2009 Unites States formulation.

Please note that the use of updated labeling for marketing your product was approved under STN 125020/716. We will include the information contained in the above-referenced supplement in your biologics license application file.

Sincerely yours,

/Jerry P. Weir/

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

 


 

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