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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

May 16, 2008 Approval Letter - FluLaval

Our STN: BL 125163/48

GlaxoSmithKline Biologicals
Attention: Mary Beth Ebert, M.S.
2301 Renaissance Boulevard
Building 510, P.O. Box 61540
King of Prussia, PA 19406-2772

Dear Ms. Ebert:

We have approved your request to supplement your biologics license application for Influenza Virus Vaccine, FluLaval, to update the language in the package insert to be consistent with new content and format labeling requirements.

Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h. Please provide a PDF-format electronic copy as well as original paper copies.

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

Sincerely yours,

/Loris D. McVittie, Ph.D./
Loris D. McVittie, Ph.D.
Acting Division Director
Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research

Attachment: Approved Final Draft Label


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