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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

August 18, 2005 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

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

 


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