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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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July 23, 2010 Approval Letter - FluLaval

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
Food and Drug Administration
Rockville, MD 20852-1448

July 23, 2010

Our STN: BL 125163/172

ID Biomedical Corporation of Quebec
Attention: LaDonna Nugent, M.S.
2301 Renaissance Boulevard
Building 510, P.O. Box 61540
King of Prussia, PA 19406-2772

Dear Ms. Nugent:

We have approved your request to supplement your biologics license application for Influenza Virus Vaccine (FluLaval), to include the 2010-2011 United States formulation.

Please submit all final printed labeling at the time of use and include implementation information on Form FDA 356h. Please provide content of labeling in Structured Product Labeling format. Please provide carton and container labeling in Structured Product Labeling format.

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

Sincerely yours,

/signature/

Jerry P. Weir, Ph.D.
Director
Division of Viral Products
Office of Vaccines
Research and Review
Center for Biologics
Evaluation and Research

Attachment: Approved Final Draft Labeling