Vaccines, Blood & Biologics
July 21, 2006 Approval Letter - Fluvirin
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
Our Submission Tracking Number (STN): BL 103837/5104
July 21, 2006
Chiron Vaccines Limited
Attn: Ms. Lisa A. Bissett
Gaskill Road, Speke
Liverpool, L24 9GR, United Kingdom
Dear Ms. Bissett:
We have approved your request to supplement your biologics license application for Influenza Virus Vaccine, to include the labeling revisions and 2006-2007 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.
Jerry A. Weir, Ph.D.
Division of Viral Products
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research