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Vaccines, Blood & Biologics

February 3, 2010 Approval Letter - Influenza A (H1N1) 2009 Monovalent Vaccine (MedImmune LLC)

Our STN:  BL 125020/1337

MedImmune, LLC
Attention: Nancy R. Kavanaugh, Ph.D.
One MedImmune Way
Gaithersburg, MD  20878

Dear Dr. Kavanaugh:

We have received your January 29, 2010, supplement to your biologics license application for Influenza Vaccine Live, Intranasal (FluMist®), to include changes to the Adverse Reaction reporting information in the Highlights section of the package insert for Influenza A (H1N1) 2009 Monovalent Vaccine, Live formulation, to accommodate the distribution of vaccine outside of United States by the WHO.

This Supplement has been reviewed under STN 125020/1337 and is approved effective this date.

This information will be included in your License Application File.

Sincerely yours,


Wellington Sun, M.D.
Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research

Attachment: Approved Final Draft Labeling

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002

Page Last Updated: 02/26/2010
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