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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

July 21, 2006 Approval Letter - Influenza Virus Vaccine Live, Intranasal

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448

July 21, 2006

Our Submission Tracking Number (STN): BL 125020/238

MedImmune Vaccines, Inc.
Attn: 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 2006-2007 United States formulation.

We will include information contained in the above-referenced supplement in your biologics license application file.

Sincerely yours,

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

 


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