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Vaccines, Blood & Biologics

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

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


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