Resubmission Letter - CINRYZE
Our STN: BL 125267/0
Lev Pharmaceuticals, Inc.
Attention: Mr. Jason Bablak
675 Third Avenue
New York , NY 10017
Dear Mr. Bablak :
We have received your 14 April 2008 resubmission to your biologics license application for C1 Esterase Inhibitor (Human) on14 April 2008.
The resubmission contains additional CMC, clinical, and statistical information that you submitted in response to our 30 January 2008 complete response letter.
We consider this a complete, class 2 response to our action letter. Therefore, the goal date is 14 October 2008.
If you have any questions, please contact me at (301) 827-6174.
Regulatory Project Manager
Division of Blood Applications
Office of Blood Research and Review
Center for Biologics Evaluation and Research