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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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March 18, 2005 Approval Letter - Influenza Virus Vaccine Live, Intranasal

Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448

March 18, 2005

Submission Tracking Number (STN): BL 125020 / 44

Peter Patriarca, MD
MedImmune Vaccines, Inc.
One MedImmune Way
Gaithersburg, MD 20878

Dear Dr. Patriarca:

The Supplement to your Biologics License Application for the Influenza Virus Vaccine Live, Intranasal (FluMist), to include changes to the previously approved 2004-2005 United States labeling (package insert), has been approved. This information will be included in your License Application file.

Please submit four copies of final printed labeling at the time of use with completed implementation information.

Sincerely yours,

--- signature ---

Karen L. Goldenthal, MD
Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research


Attachments: Final Draft Package Insert Labeling

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