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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

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July 24, 2007 Approval Letter - Fluvirin

Our STN: BL 103837/5240

July 24, 2007

Novartis Vaccines and Diagnostics Limited
Attn: Ms. Lisa 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, Fluvirin®, to include the 2007-2008 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.

Sincerely yours,

--- signature ---

Jerry Weir, Ph.D.
Director
Division of Viral Products
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research

Attachment: Final Draft Labeling of Package Insert, Carton, and Container

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