From: Maruna, Thomas
Sent: Tuesday, January 14, 2014 2:22 PM
To: Daizadeh, Iraj (iraj_daizadeh@baxter.com)
Subject: Information Requested: BLA 125512_Please Respond by January 17, 2014 
Importance: High
Our Reference: BL 125512/0
Baxter Healthcare Corporation
Attention: Iraj Daizadeh, PhD
January 14, 2014
Sent by email 
Dear Dr. Daizadeh:
We are reviewing your October 10, 2013 biologics license application (BLA) for Antihemophilic Factor (Recombinant), Porcine Sequence, indicated for the treatment and prevention of bleeding episodes in patients with acquired inhibitory antibodies to human factor VIII (i.e., acquired hemophilia patients). We determined that the following information is necessary to continue our review: 
1. Please verify whether the (b)(4) facility in ---(b)(4)----- for manufacturing of the drug product for Recombinant Porcine Factor VIII (BLA 125512/0) is ---------------------------------------(b)(4)---------------------------------------------------------------------------------------------. Please state the basis for ----(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 to this information request via email by January 17, 2014 referencing the date of this request; an amendment will not be necessary. 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.
If you have any questions, please contact me at (301) 827-6120.
Very Respectfully,
Thomas J. Maruna, MLS(ASCP)CM
Lieutenant, U.S. Public Health Service
Senior Regulatory Management Officer
Food and Drug Administration
CBER/OBRR/DBA/RPMB
1401 Rockville Pike
RM 562N, HFM-380 
Rockville, MD 20852
thomas.maruna@fda.hhs.gov
O: (301) 827-6120
BB: (240) 397-3419
www.usphs.gov 
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