July 10, 2009 Approval Letter - Afluria

July 10, 2009

Our STN:   BL 125254/118

CSL Limited
Attention:  Paul R. Hartmann
1020 First Avenue
King of Prussia, PA  19406-0901

Dear Mr. Hartmann:

We have approved your request to supplement your biologics license application for Influenza Virus Vaccine, Afluria®, to include the 2009-2010 United States formulation.

Please submit all final printed labeling at the time of use and include implementation information on FDA form 356h.  Please provide PDF-format electronic copies of these labels. 

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

Sincerely yours,

 

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