Major Amendment Letter -Eloctate

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service

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

Our STN: BL 125487/0

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

Dear Dr. Cohen:

We received your November 15, 2013 amendment to your biologics license application (BLA) submitted under section 351 of the Public Health Service Act (42 U.S.C. 262) for Antihemophilic Factor (Recombinant), Fc Fusion Protein on November 15, 2013.

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 2012and will add three months to the time by which we should complete our review. Therefore, the action due date is June 7, 2014.

We continue to review your application according to the processes described in the Guidance for Review Staff and Industry: Good Review Management Principles and Practices for PDUFA Products. Therefore, we have established internal review timelines as described in the guidance, which includes the timeframes for FDA internal milestone meetings. Because of the submission of a major amendment, we now plan to hold our late-cycle review meeting on April 3, 2013. We will inform you of any necessary information requests or status updates following the milestone meetings or at other times, as needed, during the process.

We will contact you regarding your proposed labeling no later than May 7, 2014. If post marketing study commitments (506B) are required, we will contact you no later than May 7, 2014.

If you have any questions, please contact the Regulatory Project Manager, Leigh Pracht, at (301) 827-6116.

Sincerely yours,

 

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