Accepted Proprietary Name Review Letter - RIXUBIS

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 CBERs 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.

 

Sincerely yours,

 

 

 

Basil Golding, MD

Director

Division of Hematology

Office of Blood Research and Review

Center for Biologics

 Evaluation and Research