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.
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Philip R. Krause, M.D.
Division of Viral Products
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research