Vaccines, Blood & Biologics
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
Basil Golding, M.D.
Division of Hematology
Office of Blood Research and Review
Center for Biologics
Evaluation and Research