Product Approval Information - Licensing Action
Our STN: 125127/294
August 4, 2008
GlaxoSmithKline Biologicals
Attn: Ms. Mary Beth Ebert
2301 Renaissance Boulevard
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 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.
Sincerely yours,
/Jerry Weir/
Jerry 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
