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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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July 17, 2009 Approval Letter - Fluvirin

July 17, 2009

Our STN:  BL 103837/5503                     

Novartis Vaccines and Diagnostics Limited
Attention:  Joanne Totosy de Zepetnek, PhD
350 Massachusetts Avenue
Cambridge, MA  02139

Dear Dr. Totosy de Zepetnek:

We have approved your request to supplement your biologics license application for Influenza Virus Vaccine, to include the 2009-2010 United States formulation.

Please submit final printed labeling at the time of use and include completed implementation information on FDA form 356h. Please provide PDF-format electronic copies of these labels.

We will include information contained in the above-referenced supplement in your biologics license application file.

Sincerely yours,

 

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

Attachment: Approved Final Draft Labeling