From: Maruna, Thomas
Sent: Friday, April 11, 2014 11:38 AM
To: Daizadeh, Iraj (iraj_daizadeh@baxter.com)
Cc: Ananyeva, Natalya; Poole, Catherine
Subject: Sample Lots & Reagents Requested: BLA 125512 Shipment Should be Received by April 25, 2014 
Importance: High
Baxter Healthcare Corporation
Attention: Iraj Daizadeh, PhD
April 11, 2014
Sent by email 
Dear Dr. Daizadeh:
We are reviewing your November 25, 2013 biologics license application (BLA) indicated for the treatment and prevention of bleeding episodes in patients with acquired inhibitory antibodies to human factor VIII (i.e., acquired hemophilia patients) for the following:
STN                   Name of Biological Products
BL 125512         Antihemophilic Factor Porcine, B-Domain Truncated Recombinant
We determined that the following necessary to continue our review: 
1. Please provide 4 vials from each of the following lots: --------------(b)(4)-----------------------. Please include the Potency values which you determined by both assays at the latest time-point.
2. If additional, recently manufactured, lots are available, please provide 4 vials from 2 different lots. Please include the testing information for these lots if they are not included in the BLA. 
3. Please provide -----(b)(4)------------ from two different lots. 
Please ship samples and reagents to the address below by April 25, 2014:
Catherine Poole
Regulatory Coordinator
Division of Biological Standards and Quality Control (DBSQC)/OCBQ/CBER/FDA
NLRC Bldg. B, Room 2411
5516 Nicholson Lane
Kensington, MD 20985
Office: 301-594-6272 
The review of this submission is on-going and issues may be added, expanded upon, or modified as we continue to review this submission.
If it is not feasible for Baxter to provide the samples and reagents requested by April 25th, please provide an alternative date. 
The action due date for these files is July 26, 2014.
If you have any questions, please contact me at (301) 827-6120.
Very Respectfully,
Thomas J. Maruna, MSc, 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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