DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Silver Spring, MD 20993
May 28, 2014
Our STN: BL 125512/0                     MAJOR AMENDMENT ACKNOWLEDGEMENT
Baxter Healthcare Corporation
Attention: Iraj Daizadeh, PhD
One Baxter Way
Westlake Village, CA 91362
Dear Dr. Daizadeh:
We received your April 25, 2014 amendment to your biologics license application (BLA) submitted under section 351 of the Public Health Service Act (42 U.S.C. 262) for Antihemophilic Factor (Recombinant), Porcine Sequence, on April 28, 2014.
We consider your submission a major amendment under the reauthorization of the prescription drug user fee program in the Food and Drug Administration Safety and Innovation Act of 2012 and will add an additional three months to the time by which we should complete our review. Therefore, the action due date is October 25, 2014.
If you have any questions, please contact the Regulatory Project Manager, LT Thomas J. Maruna, USPHS, MSc, MLS(ASCP)CM at (240) 402-8454.
Sincerely yours,
Basil Golding, MD
Director 
Division of Hematology Research and Review
Office of Blood Research and Review
Center for Biologics Evaluation and Research

