March 10, 2014
Our STN: BL 125512/0
Baxter Healthcare Corporation
Attention: Iraj Daizadeh, PhD
One Baxter Parkway 
Westlake Village, CA 91362
Dear Dr. Daizadeh:
We have reviewed your submission dated December 10, 2013 to your biologics license application (BLA) for Antihemophilic Factor (Recombinant), Porcine Sequence, requesting a proprietary name review.
In consultation with CBER’s Advertising and Promotional Labeling Branch (APLB) we conclude that under the Federal Food, Drug, and Cosmetic Act and applicable regulations, your proposed proprietary name, OBIZURTM, is acceptable at this time.
We will perform another proprietary name review of OBIZURTM closer to the time of the action due date to ensure that we have not approved a conflicting proprietary name for another product in the interim.
If you have any questions, please contact LT Thomas J. Maruna, USPHS, MSc, MLS(ASCP)CM at (301) 827-6120.
Sincerely yours,
Basil Golding
Director
Division of Hematology
Office of Blood Research and Review
Center for Biologics 
Evaluation and Research

