Vaccines, Blood & Biologics
Filing Letter - CINRYZE
Our STN: BL 125267/0
Lev Pharmaceuticals, Inc.
Attention: Mr. Jason Bablak
675 Third Avenue
New York , NY 10017
Dear Mr. Bablak :
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 July 31, 2007 for C1 Esterase Inhibitor (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 30, 2008. 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.
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, Nannette Cagungun, at (301) 827-6174.
Division of Blood Applications
Office of Blood Research and Review
Center for Biologics Evaluation and Researc