Our STN: BL 125385/0
CSL Behring GmbH
Attention: Mr. Paul R. Hartmann
1020 First Avenue, P.O. Box 61501
King of Prussia, PA 19406-0901
Dear Mr. Hartmann:
We have reviewed your submission dated August 18, 2010 to your biologics license application (BLA) for Factor XIII 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, Corifact, is acceptable at this time.
If you have any questions, please contact Ms. Nannette Cagungun at (301) 827-6174.
Basil Golding, M.D.
Division of Hematology
Office of Blood Research and Review
Center for Biologics
Evaluation and Research