January 16, 2014
Our STN: BL 125512/0
Baxter Healthcare Corporation
Attention: Iraj Daizadeh, PhD
One Baxter Way
Westlake Village, CA 91362
Dear Dr. Daizadeh:
This letter is in regard to your biologics license application (BLA) submitted under section 351 of the Public Health Service Act.
We have completed an initial review of your application dated November 25, 2013 for Antihemophilic Factor (Recombinant), Porcine Sequence to determine its acceptability for filing. Under 21 CFR 601.2(a), we have filed your application today. The review goal date is July 26, 2014. This acknowledgment of filing does not mean that we have issued a license nor does it represent any evaluation of the adequacy of the data submitted.
We will contact you regarding your proposed labeling no later than June 26, 2014. If post marketing study commitments (506B) are required, we will contact you no later than June 26, 2014.
At this time, we have not identified any potential review issues. Our filing review is only a preliminary review, and deficiencies may be identified during substantive review of your application. Following a review of the application, we shall advise you in writing of any action we have taken and request additional information if needed.
If you have any questions, please contact the Regulatory Project Manager, LT Thomas J. Maruna, USPHS, MSc, MLS(ASCP)CM, at (301) 827-6120.
Sincerely yours,
Iliana Valencia
Chief
Regulatory Project Management Branch
Division of Blood Applications
Office of Blood Research and Review
Center for Biologics Evaluation and Research

