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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

July 3, 2008 Approval Letter - Influenza Virus Vaccine Live, Intranasal

Our Submission Tracking Number (STN): BL 125020/716

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 labeling revisions for the 2008-2009 influenza season.

Please note that the use of this updated labeling for marketing your product is subject to approval of your supplement STN 125020/-------------------------------------------. We will include information contained in the above-referenced supplement in your biologics license application file.

Sincerely yours,

/Loris McVittie/

Loris D. McVittie, Ph.D.
Acting Director
Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research

Attachment: Final Draft Labeling


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