Unaccepted 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: BL 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 August 28, 2012 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 name, —b(4)------, is unacceptable.
The basis for our decision is:
- Your proposed name might be confused with other medicinal products with orthographic or phonological similarities within the meaning of 21 CFR 201.10(c)(5).
--b(4)------------ is unacceptable because there is a potential for medication error with HIZENTRA and HERCEPTIN due to phonologic and orthographic similarities, and when considering use environment and storage conditions.
You may submit a new proprietary name for FDA consideration. Any alternate proprietary name should comply with the regulations regarding false, misleading or fanciful names and should not be confused with other medicinal products with orthographic or phonological similarities.
If you have any questions, please contact Edward Thompson at (301) 827-9167.
Basil Golding, MD
Division of Hematology
Office of Blood Research and Review
Center for Biologics
Evaluation and Research