Unaccepted Proprietary Name Review Letter - RIXUBIS

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 CBERs 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:

 
1.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.

 

 

Sincerely yours,

 

 

 

Basil Golding, MD

Director

Division of Hematology

Office of Blood Research and Review

Center for Biologics

 Evaluation and Research