Informatio Request Memo, March 18, 2014 - Eloctate
 
DEPARTMENT OF HEALTH & HUMAN SERVICES 

Public Health Service

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

Our Reference: BL 125487/0

Biogen Idec Inc.
 Attention: Mr. Elijah Tan
 March 18, 2014
 Sent by email

Dear Mr. Tan:

We are reviewing your March 7, 2013 biologics license application (BLA) for Antihemophilic Factor (Recombinant), Fc Fusion protein. We are providing the following comment:
1.Based on historical and current US clinical practice, please label product vials of Antihemophilic Factor (Recombinant), Fc Fusion Protein with potencies determined using a one-stage clotting assay.

The review of this submission is on-going and issues may be added, expanded upon, or modified as we continue to review this submission.

The action due date for this file is June 7, 2014.

If you have any questions, please contact me at (301) 827-6116.

Sincerely,

Leigh Pracht
 Regulatory Project Manager
 FDA/CBER/OBRR/DBA/RPMB
