Date of Response: 16 January 2014
Attention: Lt. Thomas Maruna, MLS (ASCP)CM
Regulatory Project Management Branch
Division of Blood Applications
Biologics License Application 125512/0
Antihemophilic Factor (Recombinant), Porcine Sequence (OBI-1)
Response to Information Request
Dear Lt. Maruna:
Baxter Healthcare Corporation (Baxter) is submitting this response per the information request dated 14 January 2014.
FDA Question:
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 the same manufacturing facility and same FEI as for the -----------------------------------------------------------------------------(b)(4)--------------------------------------. 
Baxter Response: ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(b)(4)----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(b)(4)--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(b)(4)-----------------------.
Should you have any questions, please contact me at (805) 372-4934 or iraj_daizadeh@baxter.com. The secondary contact is Linda Lemieux, MS, Associate Director, Global Regulatory Affairs, who can be reached at (508) 282-5698 or linda_lemieux@baxter.com. All fax correspondence should be sent to (805) 372-3042.
Sincerely,
Iraj Daizadeh, PhD
Regulatory Affairs | p:805-372-4934 / f:805-372-3052 | iraj_daizadeh@baxter.com
Mail Box Number: 1A-3, One Baxter Way, Westlake Village, CA 91362
The information transmitted is intended only for the person or entity to which it is addressed and may contain confidential and/or privileged material. Any review, re-transmission, dissemination or other use of, or taking of any action in reliance upon, this information by persons or entities other than the intended recipient is prohibited. If you received this in error, please contact the sender and delete the content.
From: Maruna, Thomas [mailto:Thomas.Maruna@fda.hhs.gov] 
Sent: Tuesday, January 14, 2014 11:22 AM
To: Daizadeh, Iraj
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 the same manufacturing facility and same FEI as --------------------------------------------------------------------------------(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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