Information Request, April 4, 2014 - Eloctate

From: Pracht, Leigh
Sent: Friday, April 04, 2014 3:01 PM
To: Debra Segal
Cc: Elijah Tan (elijah.tan@biogenidec.com)
Subject: STN 125487/0 Information Request: Diluent Stability&NDC codes 040414

Importance: High

Our Reference: BL 125487/0

Biogen Idec Inc.
Attention: Ms. Debra Segal
April 4, 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 for additional information to continue our review:

1. The stability data for the diluent (sterile Water for Injection) you provided in an amendment dated 19 December 2013, support the shelf life of the diluent to be less than 24 months when the diluent is stored at 30ºC. However, you have proposed that the shelf life of the diluent be –b(4)--------- under storage at –b(4)----. Please revise your proposed shelf life of the diluent to be 60 months under storage at 2 – 8ºC. Within this period, the diluent may be stored at room temperature (up to 30ºC) for up to 6 months when packaged with rFVIIIFc DP.

2. Please revise your assignment of the National Drug Code (NDC) number on your carton and container labels to comply with 21 CFR 207.35 (b)(2)(ii). The last 5 numeric characters of the 10-character code identify the drug and the trade package size and type. The segment that identifies the drug formulation is known as the Product Code and the segment that identifies the trade package size and type is known as the Package Code. The carton/hardpack label and the container (vial) label should each be assigned a unique NDC code.


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 April 18, 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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