Information Request, May 20, 2014 - Eloctate

From:                                             Pracht, Leigh
Sent:                                               Tuesday, May 20, 2014 4:25 PM
To:                                                  Debra Segal
Cc:                                                   Elijah Tan (elijah.tan@biogenidec.com)
Subject:                                         STN 125487 Information Request (Carton and Container Labels)  052014

Importance:                                 High

Our Reference:  BL 125487/0

Biogen Idec Inc.
Attention:  Ms. Debra Segal
May 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 providing these comments and request your acknowledgement to continue our review:

1.  Please remove the design that is currently located next to the trade name, ELOCTATE™.
2.   Please display the proper name of the product, Antihemophilic Factor (Recombinant), Fc Fusion Protein.
3.   Please change the reconstituted storage time from –b(4)-. to 3 hr.
4.   Please change potency “range” to potency “nominal,” e.g., 1000 IU Range should be 1000 IU Nominal.

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 as soon as possible 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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