July 15, 2009
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, Fluarix®, 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 information contained in the above-referenced supplement in your biologics license application file.
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