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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

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,

--signature--

Wellington Sun, M.D.
Director
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

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Building 71 Room 3103

Silver Spring, MD 20993-0002