
Proprietary Name Review Letter - Kcentra

 

Our STN: 125421/0                                                                           

 

 

CSL Behring GmbH

Attention: Paula Hines, Ph.D.

1020 First Avenue, P.O. Box 61501

King of Prussia, PA  19406-0901

 

 

Dear Dr. Hines:

 

We have reviewed your submission dated September 7, 2012 to your biologics license application (BLA) for Prothrombin Complex Concentrate (Human) 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, BERIPLEX, is still unacceptable. The review of the alternative proposed proprietary name, KCENTRA, is found to be acceptable at this time.

 

If you have any questions, please contact Beth Walton at (301) 827-3762

 

Sincerely yours,

 

 /s/

 

Basil Golding, M.D.

Director

Division of Hematology

Office of Blood Research and Review

Center for Biologics

Evaluation and Research