
Filing NDI Letter - Flucelvax



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