Posted by ed_uk on November 1, 2006, at 15:35:48
In reply to US FDA issues “approvable” letter for tipataflam, posted by ed_uk on November 1, 2006, at 14:16:01
SAN DIEGO--(BUSINESS WIRE)--Oct 31, 2006 - AVANIR Pharmaceuticals (NASDAQ:AVNR) announced that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) for Zenvia(TM) (formerly referred to as Neurodex(TM)) for the treatment of involuntary emotional expression disorder ("IEED"). The Company submitted a new drug application ("NDA") in January 2006, seeking to market Zenvia for the treatment of IEED in patients with neurologic diseases and brain injuries. The communication from the FDA indicates that AVANIR's application is approvable, subject to the FDA and AVANIR reaching agreement on what additional safety and efficacy data will be required.
poster:ed_uk
thread:699609
URL: http://www.dr-bob.org/babble/20061028/msgs/699628.html