Posted by SFY on September 21, 2005, at 12:50:27
In reply to Re: FDA panel to review EMSAM on Oct 25th, posted by Cecilia on September 21, 2005, at 3:43:04
The food interaction issue is the hangup on approval. The studies show no food interaction issues and the company wants to market Emsam without the dietary restrictions. Otherwise, there is very little advantage over Nardil and Parnate. The FDA asked for more data on this issue which has been the primary reason for the hold up in final approval.
poster:SFY
thread:555724
URL: http://www.dr-bob.org/babble/20050921/msgs/557658.html