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