From: Kumar, Vasantha
Sent: Tuesday, June 10, 2014 5:08 PM
To: 'iraj_daizadeh@baxter.com'
Cc: Maruna, Thomas
Subject: Information Request. STN BL 125512. Please respond by June 19 via email.
Importance: High
Dear Dr. Daizadeh,
I am writing on behalf of Thomas Maruna.
We are currently in the process of reviewing your BLA, BL 125512, and we need the following information to proceed with the review.
I may add that this is a follow-up to April 11, 2014 request for additional samples of OBI- Drug Product for in-support testing.
1. Please submit the following information regarding the test samples provided for the FVIII chromogenic assay in-support testing by FDA: 
The manufacture date and the Potency values of the following OBI-1 samples at release as measured in the FVIII chromogenic assay:
      Lot ---------(b)(4)------
      Lot ---------(b)(4)------
The following information on Potency values at release had already been provided by Baxter as part of your application:
Reagent
Potency (U/vial) (OSCA)
Potency (U) (FVIII chromogenic assay)
---(b)(4)---
490
298
------(b)(4)---------
470
297
------(b)(4)---------
490
322
------(b)(4)---------
498
 
------(b)(4)---------
485
 
In addition, please provide the most current Potency values obtained by the chromogenic method and indicate respective dates and time points when the testing was performed for all five lots of OBI-1 Antihemophilic Factor (Recombinant), Porcine Sequence.
Please submit your responses via e-mail by June 19, 2014.
Thanks
Vasantha
Vasantha Kumar, Ph.D.
U.S.Food & Drug Administration
CBER/OBRR/RPMB
10903 New Hampshire Ave.
White Oak Building 71, Rm 4206
Silver Spring, MD 20993-0002
Phone: (240) 402-8413
Fax: (301) 595-1128
E-Mail: vasantha.kumar@fda.hhs.gov
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