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:
This letter is in regard to your biologics license application (BLA) submitted under section 351 of the Public Health Service Act.
We have completed an initial review of your application dated March 30, 2012 for Prothrombin Complex Concentrate (Human) to determine its acceptability for filing. Under 21 CFR 601.2(a), we have filed your application today. The review goal date is January 28, 2013. This acknowledgment of filing does not mean that we have issued a license nor does it represent any evaluation of the adequacy of the data submitted.
We will contact you regarding your proposed labeling no later than December 29, 2012. If postmarketing study commitments (506B) are required, we will contact you no later than December 29, 2012.
At this time, we have not identified any potential review issues. Our filing review is only a preliminary review, and deficiencies may be identified during substantive review of your application. Following a review of the application, we shall advise you in writing of any action we have taken and request additional information if needed.
If you have any questions, please contact the Regulatory Project Manager, Beth Walton, at (301) 827-3762
Chief, Regulatory Project
Office of Blood Research and Review
Center for Biologics
Evaluation and Research