Information Request, September 27, 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

Biogen Idec Inc.
Attention:  Ms. Debra Segal
September 27, 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 these comments and request for additional information to continue our review:

1. Regarding your response to the July 24th Information Request, Item 4 b, concerning the assay for –b(4)----------------------------------------------------------------, it is critical that           –b(4)---------------------------------------------- --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------.

2. Regarding the procedure for Residual Moisture using ----b(4)---  

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

Please submit your response by October 28, 2013, referencing the date of this request.

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