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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

Filing NDI Letter - Flucelvax

DEPARTMENT OF HEALTH & HUMAN SERVICES                                                     Public Health Service
 


 

                                                                                                                            Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448

 

Our STN: BL 125408/0
 
Novartis Vaccines & Diagnostics, Inc.                     
Attention: John Barry, Ph.D.
350 Massachusetts Avenue   
Cambridge, MA 02139
 
Dear Dr. Barry:
 
This letter is in regard to your biologics license application (BLA) submitted under section 351 of the Public Health Service Act.
 
We have completed an initial review of your application dated October 31, 2011, for Influenza Vaccine (MDCK Cells), to determine its acceptability for filing. Under 21 CFR 601.2(a), we have filed your application today. The review goal date is September 21, 2012. This acknowledgment of filing does not mean that we have issued a license nor does it represent any evaluation of the adequacy of the data submitted.
 
We will contact you regarding your proposed labeling no later than August 21, 2012. If post marketing study commitments (506B) are required, we will contact you no later than
August 21, 2012.
 
At this time, we have not identified any potential review issues for inclusion in this letter. Our filing review is only a preliminary review, and deficiencies may be identified during substantive review of your application. Following a review of the application, we shall advise you in writing of any action we have taken and request additional information if needed.
 
If you have any questions, please contact the Regulatory Project Managers, Timothy Fritz, Ph.D. and Brenda Baldwin, Ph.D., at (301) 796-2640.
 
Sincerely yours,
 
 
 
Wellington Sun, M.D.
Director
Division of Vaccines and
 Related Products Applications
Office of Vaccines
 Research and Review
Center for Biologics
 Evaluation and Research