Vaccines, Blood & Biologics
September 14, 2005 Approval Letter - Fluvirin
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
September 14, 2005
Our Submission Tracking Number (STN): BL 103837/5066
Attn: Miss Lisa Bissett
Chiron Vaccines Limited, Inc.
Gaskill Road, Speke
Liverpool, L24 9GR, United Kingdom
Dear Miss. Bissett:
We have approved your request to supplement your biologics license applications for Influenza Virus Vaccine, to include the 2005-2006 United States formulation.
We will include the information contained in the above-referenced supplement in your biologics license application file.
--- signature ---
Philip R. Krause, M.D.
Division of Viral Products
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research