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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

September 12, 2007 Approval Letter - FluLaval

Our STN: BL 125163/39

ID Biomedical Corporation of Maryland
Attn: Jane L. Halpern, Ph.D.
Director, Regulatory Affairs
6996 Columbia Gateway Drive, Suite 103
Columbia, MD 21046-3303

Dear Dr. Halpern:

We have approved your request to supplement your biologics license application for Influenza Virus Vaccine, FluLaval, to include the 2007-2008 United States formulation. We will include information contained in the above-referenced supplement in your biologics license application file.

Please submit four copies of final printed labeling at the time of use with completed implementation information.

Sincerely yours,

--- signature ---

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

Attachment: Final Draft Labeling of Package Insert, Carton, and Container


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