Accepted Proprietary Name Review Letter - RIXUBIS
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
Our STN: 125446/0
Baxter Healthcare Corporation
Attention: Mr. Kevin Smyth
One Baxter Way
Westlake Village, CA 91362
Dear Mr. Smyth:
We have reviewed your submission dated March 4, 2013 to your biologics license application (BLA) for Coagulation Factor IX (Recombinant) 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, RIXUBIS, is acceptable at this time. In addition, we recommend distinctive packaging of the final product to further differentiate RIXUBIS from other medicinal products with the same storage environment.
We will perform another proprietary name review of RIXUBIS 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 Edward M. Thompson at (301) 827-9167.
Basil Golding, MD
Division of Hematology
Office of Blood Research and Review
Center for Biologics
Evaluation and Research