Product Approval Information - Licensing Action
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
Our STN: BL 125127/139
July 25, 2006
GlaxoSmithKline Biologicals
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 2006-2007 United States formulation. We will include information contained in the above-referenced supplement in your biologics license application file.
Please submit final printed labeling at the time of use with completed implementation information.
Sincerely yours,
Jerry Weir, Ph.D.
Director
Division of Viral Products
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research