July 22, 2010 Approval Letter - FluMist

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
Food and Drug Administration
Rockville, MD 20852-1448

July 22, 2010

Our STN: BL 125020/1436
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 Vaccine, Intranasal (FluMist®) to include the 2010-2011 United States formulation.

Please submit all final printed labeling at the time of use and include implementation information on Form FDA 356h. Please provide content of labeling in Structured Product Labeling format. Please provide carton and container labeling in Structured Product Labeling format. Please note that the Package Insert for the 2010-2011 United States formulation was approved under STN 125020/1324.

We will include the information contained in the above referenced supplement in your Biologics License Application file.

Sincerely yours,

/signature/

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