July 30, 2008 Approval Letter - Afluria
Our STN: BL 125254/74
Attention: Paul R. Hartmann
1020 First Avenue
P.O. Box 60446
King of Prussia , PA 19406-0446
Dear Mr. Hartmann:
We have approved your request to supplement your Biologics License Application for Influenza Virus Vaccine, to include the 2008-2009 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.
/Jerry P. Weir/
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