Request for Information Letter, November 1, 2013 - Eloctate

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service


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

Our Reference:  BL 125487/0/23

Biogen Idec Inc.
 Attention:  Ms. Debra Segal
 November 1, 2013
 Sent by email

Dear Ms. Segal:

We are reviewing your March 7, 2013 biologics license application (BLA) for Antihemophilic Factor (Recombinant), Fc Fusion protein.  We are providing the following comments:

•As discussed during the 10/8/2013 telecon, the Method 2 study is adequate for us.

•The evaluated temperatures for the empty chamber shelf temperature mapping study should reflect the actual lyophilization cycle for manufacturing.  We recommend that you also include the –b(4)--- temperature as a temperature test point, since that is the main drying cycle temperature for your product.

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 March 8, 2014.

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

Sincerely,

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