Information Request, April 23, 2014 - Eloctate

From: Pracht, Leigh
Sent: Wednesday, April 23, 2014 6:33 PM
To: Debra Segal
Cc: Elijah Tan (elijah.tan@biogenidec.com)
Subject: STN 125487/0 CMC Information Request 042314

Importance: High

Our Reference: BL 125487/0

Biogen Idec Inc.
Attention: Ms. Debra Segal
April 23, 2014
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 requesting this information in order to continue our review:

    Please update section 3.2.P.5.1 with the revised drug product release specification that includes testing of excipients and 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 April 30, 2014 referencing the date of this request.

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

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

Best regards,

Leigh A. Pracht
Regulatory Project Manager
FDA/CBER/OBRR/DBA
WOC1; RM562N; HFM-380
1401 Rockville Pike
Rockville, MD 20852
Telephone: 301-827-6116
Fax: 301- 827-2857
Leigh.Pracht@fda.hhs.gov

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