Major Amendment Letter - Kcentra
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
Our STN: BL 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 received your December 14, 2012 amendment to your biologics license application (BLA) submitted under section 351 of the Public Health Service Act (42 U.S.C. 262) for Prothrombin Complex Concentrate (Human) on December 14, 2012.
We consider your submission a major amendment under the reauthorization of the prescription drug user fee program in the Food and Drug Administration Amendments Act of 2007.
Because we received this major amendment within three months of the action due date, we will add an additional three months to the time by which we should complete our review. Therefore, the action due date is April 29, 2013.
If you have any questions, please contact the Regulatory Project Manager, Beth Walton, at (301)-827-3762.
Basil Golding, MD
Division of Hematology
Office of Blood Research and Review
Center for Biologics
Evaluation and Research