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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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July 15, 2011 Approval Letter- AFLURIA 2011/2012 Formulation

Our STN:   BL 125254/303

CSL Biotherapies
Attention: Paul R. Hartmann, R.Ph.
1020 First Avenue
P.O. Box 60446
King of Prussia, PA 17406-0446

Dear Mr. Hartmann:

We have approved your request to supplement your biologics license application for Influenza Vaccine, AFLURIA®, to include the 2011-2012 United States formulation.

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

We will include information contained in the above-referenced supplement in your Biologics License Application file.

Sincerely yours,

Jerry P. Weir, Ph.D.
Division of Viral Products
Office of Vaccines
 Research and Review
Center for Biologics
 Evaluation and Research
Attachment: Approved Final Draft Labeling