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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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April 23, 2010 Approval Letter - FluLaval

April 23, 2010

Our STN:  BL 125163/157                

GlaxoSmithKline Biologicals
Attention:  Marisha Stanislaus, Ph.D.
2301 Renaissance Boulevard
Building 510, P.O. Box 61540
King of Prussia, PA 19406-2772

Dear Dr. Stanislaus:

We have approved your request to supplement your biologics license application for Influenza Virus Vaccine, FluLaval, to revise the Pregnancy Category in the package insert from the current Pregnancy Category C to Pregnancy Category B.

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

In addition, you may wish to submit draft copies of the proposed introductory advertising and promotional labeling with an FDA Form 2253 to the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Branch, HFM-602, 1401 Rockville Pike, MD 20852-1448.  Please submit your final printed advertising and promotional labeling at the time of initial dissemination, accompanied by an FDA Form 2253.

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

If you have any questions, please contact Dr. Sara Gagneten, Regulatory Project Manager, at (301) 827-3070.

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 Label