From: Maruna, Thomas
Sent: Thursday, December 19, 2013 6:13 PM
To: Daizadeh, Iraj (iraj_daizadeh@baxter.com)
Cc: Bobo, Qiao; Cagungun, Nannette
Subject: Information Requested: BLA 125512/0_Please Respond By December 27, 2013
Importance: High
Baxter Healthcare Corporation
Attention: Iraj Daizadeh, PhD
December 19, 2013
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) for the following:
STNs                    Name of Biological Products
BL 125512/0         Antihemophilic Factor (Recombinant), Porcine Sequence 
We determined that the following information is necessary to continue our review: 
1. Regarding your drug product manufacturing facility (b)(4), 
a. Please list in detail the difference and similarities between the manufacturing of the FDA approved product (b)(4) and the proposed drug product including, but not limited to facility, rooms and equipment used, manufacturing process, container- closure system, validation approach. 

b. Is the establishment performing significant manufacturing step(s) in new (unlicensed) areas using different equipment (representing a process change)? This would include areas that are currently dedicated areas that have not been approved as multi-product facilities/buildings/areas.

c. Is the manufacturing process is significantly different (new production methods, specialized equipment or facilities) from that of (b)(4) produced by the establishment.

d. In Section 3.2.P.1.1, Table 1, both the (b)(4) facility and the Baxter ----(b)(4)-------- facility have 100% visual inspection, vial labeling and secondary packaging responsibilities. Please clarify.

2. Regarding your secondary packaging facility in (b)(4), the firm information in your submission is different than the firm information in the 2012 establishment inspection report (EIR) (see below). If they are the same firm, please explain the differences in the record.
Firm information in (b)(4) EIR: 
----(b)(4)-----
Baxter Healthcare Corporation- Baxter (b)(4)
---(b)(4)---------
--------------------
Information provided in the submission:
---------------
----------(b)(4)----------
---------
--------
------
3. Please clarify the relationships among Baxter Healthcare Corporation, Baxter (b)(4)--, (b)(4) and Baxter ---(b)(4)--------.

4. Please submit a request for Categorical Exclusion with the basis as outlined in 21 CR Part 25.31(a), (b) or (c).

5. Please provide the FDA license numbers for Baxter (b)(4)-- and Baxter -----(b)(4)---------.

6. In your November 25, 2013 amendment, 125512/0.2, under Tab 5.3.5.2 OBI-1-301, the folder “Patients Excluded from Efficacy Analysis” contains a listing of demographics and baseline characteristics, but does not include a list of excluded subjects; the folder “Demographic Data” contains a listing of target bleeds at screening instead of demographic data. Please correct the organization of the submitted data and submit the omitted data (i.e. a list of patients excluded from the efficacy analysis). 
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 as an amendment to this file by December 27, 2013 referencing the date of this request. In addition, please respond via email to thomas.maruna@fda.hhs.gov and qiao.Bobo@fda.hhs.gov in an effort to expedite our review.
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, 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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