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Vaccines, Blood & Biologics

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July 17, 2009 Approval Letter - FluMist Label Revisions

 

July 17, 2009

Our STN: BL 125020/1086

MedImmune, LLC
Attention: 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 (FluMistĀ®), to include labeling revisions for the 2009-2010 influenza season.

Please note that the use of this updated labeling for marketing your product is subject to approval of your supplement STN 125020/1163 for the annual influenza strain changes.

Please submit final printed labeling at the time of use and include completed implementation information on FDA form 356h. Please provide PDF-format electronic copies of these labels.

We will include information contained in the above-referenced supplement in your biologics license application file.

Sincerely yours,

 

 

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