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Vaccines, Blood & Biologics

Acknowledgement Letter - Agriflu, July 21, 2008

July 21, 2008 

Novartis Vaccines & Diagnostics, Inc. 

Attention: Ms. Joanne Totosy de Zepetnek 

350 Massachusetts Avenue 

Cambridge, MA 02139 

Dear Ms. Totosy de Zepetnek: 

We have received your biologics license application (BLA) submitted under section 351 of the Public Health Service Act for the following biological product: 

Our Submission Tracking Number (STN): BL 125297/0 

Biological Product: Influenza Vaccine

Indication: Active immunization of adults 18 years of age and older against influenza disease.

Date of Supplement: July 10, 2008 

Date of Receipt: July 11, 2008

First Action Due Date: May 11, 2008 

US License Number: 1751 We will notify you within 60 days of the receipt date if the application is sufficiently complete to permit a substantive review. 

Please submit all future correspondence, supporting data, or labeling relating to this application in triplicate, citing the above STN number. 

Send all correspondence to the following address: 

Norman Baylor, Ph.D., 
HFM-475 

Center for Biologics Evaluation and Research 
Food and Drug Administration 
Suite 200N 
1401 Rockville Pike 
Rockville, MD 20852-1448

If you have any questions, please contact Dr. Bernard McWatters, Regulatory Project Manager, at (301) 827-3070. 

Sincerely yours,

Loris D. McVittie, Ph.D. 
Chief Viral Vaccine Branch 
Division of Vaccines and Related Products Applications 
Office of Vaccines Research and Review 
Center for Biologics Evaluation and Research

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