Information Request, April 20, 2014 - Eloctate

From: Pracht, Leigh
Sent: Sunday, April 20, 2014 4:23 PM
To: Debra Segal
Cc: Elijah Tan (elijah.tan@biogenidec.com)
Subject: STN 125487.0 Information Request 042014

Importance: High

Our Reference: BL 125487/0

Biogen Idec Inc.
Attention: Ms. Debra Segal
April 20, 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 the following information to continue our review:

    Please submit a MS WORD version of the IFU.

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 23, 2014 referencing the date of this request. Include both a red-line strike out and clean copy of the revised package insert in WORD format. If you anticipate you will not be able to respond by this date, please contact the Agency immediately so a new response date can be identified.

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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