Vaccines, Blood & Biologics
July 14, 2005 Approval Letter - Fluzone
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
July 14, 2005
Our STN: BLA 103914/5101
Luc Kuykens, MD, MPH, DTM
Aventis Pasteur Inc.
Discovery Drive
Swiftwater, PA 18370-0187
Dear Dr. Kuykens:
The Supplement to your Biologics License Application for the Influenza Virus Vaccine, to include the 2005-2006 United States formulation, has been approved. This information will be included in your License Application file.
Please submit four copies of final printed labeling at the time of use with completed implementation information.
Sincerely yours,
--- signature ---
Philip R. Krause, M.D.
Acting Director
Division of Viral Products
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research