
Major Amendment Letter - Flucelvax

 

 
 

Our STN: BL 125408/0

 

Novartis Vaccines and Diagnostics, Inc.

Attention: Matthew Gollwitzer

350 Massachusetts Avenue

Cambridge, MA 02139

 

Dear Mr. Gollwitzer:

 

We received your September 11, 2012, amendment to your biologics license application (BLA) submitted under section 351 of the Public Health Service Act (42 U.S.C. 262) for Influenza Vaccine (MDCK Cells) on September 12, 2012.

 

We consider your submission a major amendment under the reauthorization of the prescription drug user fee program in the Food and Drug Administration Amendments Act of 2007.

 

Because we received this major amendment within three months of the action due date, we will add an additional three months to the time by which we should complete our review. Therefore, the action due date is December 21, 2012.

 

If you have any questions, please contact Drs Brenda Baldwin or Timothy Fritz at 301-796-2640.

 

Sincerely yours,

 

    /s/

 

Wellington Sun, M.D.

Director

Division of Vaccines and

 Related Product Applications

Office of Vaccines

 Research and Review

Center for Biologics

 Evaluation and Research