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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Proprietary Name Review Letter - Kcentra

DEPARTMENT OF HEALTH & HUMAN SERVICES                                                     Public Health Service
 


                                                                                                                            Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448

 

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