Product Approval Information - Licensing Action
Our STN: BL 125127/229
July 24, 2007
GlaxoSmithKline Biologicals
Attn: 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 2007-2008 United States formulation. We will include information contained in the above-referenced supplement in your biologics license application file.
Please submit four copies of final printed labeling at the time of use with completed implementation information.
Sincerely yours,
--- signature ---
Jerry Weir, Ph.D.
Director
Division of Viral Products
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
