Vaccines, Blood & Biologics
August 5, 2008 Approval Letter - Fluarix
Our STN: 125127/294
August 4, 2008
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.
Jerry Weir, Ph.D.
Division of Viral Products
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
Attachment: Approved Final Draft Labeling