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DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Food and Drug Administration 1401 Rockville Pike Rockville, MD 20852-1448 August 18, 2005 Submission Tracking Number (STN): BL 125020 / 69 Attn: Kimber L. Poffenberger, Ph.D. MedImmune Vaccines, Inc. One MedImmune Way Gaithersburg, MD 20878 Dear Dr. Poffenberger: We have approved your request to supplement your biologics license application for Influenza Virus Vaccine Live, Intranasal, to include 2005-2006 United States formulation. We will include information contained in the above-referenced supplement in your biologics license application file. Sincerely yours, --- signature --- Philip R. Krause, M.D. Acting Director Division of Viral Products Office of Vaccines Research and Review Center for Biologics Evaluation and Research

Updated August 18, 2005

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