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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

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.

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


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