Major Amendment Letter, ALPROLIX

DEPARTMENT OF HEALTH & HUMAN SERVICES
 Public Health Service


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

Our STN: BL 125444/0

Biogen Idec, Inc.
 Attention: Nadine Cohen, PhD
 14 Cambridge Center
 Cambridge, MA 02142

Dear Dr. Cohen:

On November 20, 2013, we received an amendment to your biologics license application (BLA) for Coagulation Factor IX (Recombinant), Fc Fusion Protein, submitted under section 351(a) of the Public Health Service Act (42 U.S.C. 262).

We consider your submission a major amendment under the reauthorization of the prescription drug user fee program in the Food and Drug Administration Safety and Innovation Act of 2012 and will add three months to the time by which we should complete our review. Therefore, the action due date is March 29, 2014.

If you have any questions, please contact the Regulatory Project Manager, Edward Thompson, at (301) 827-9167.

Sincerely yours,

 

Basil Golding, MD
 Director
 Division of Hematology
 Office of Blood Research and Review 
 Center for Biologics
 Evaluation and Research
