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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

Letter - Agriflu

Our STN:  BL 125297/0

Novartis Vaccines and Diagnostics, Inc.

Attention:  Joanne Totosy de Zepetnek

4560 Horton Street

Emeryville, CA   94608-2916

Dear Dr. Totosy de Zepetnek:

We have received your May 29, 2009, resubmission to your biologics license application for Influenza Vaccine, for the active immunization of adults 18 years of age and older against influenza disease on May 29, 2009.

We consider this a complete, Class 2 response to our action letter.  Therefore, the user fee goal date is November 28, 2009.

If you have any questions, please contact the Regulatory Project Manager,

Dr. Bernard McWatters, at (301) 827-3070.

Sincerely yours,

Wellington Sun, M.D.
Director
Division of Vaccines and Related Product Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research