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Re: FDA panel to review EMSAM on Oct 25th

Posted by cecilia on September 21, 2005, at 18:35:58

In reply to Re: FDA panel to review EMSAM on Oct 25th » Cecilia, posted by SFY on September 21, 2005, at 12:50:27

> 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.

Beyond the food issues, it seems to me that Emsam would have enormous advantages over Nardil and Parnate (neither of which I could tolerate) in terms of side effects. IF what was written about lack of side effects with Emsam is true, but like I said, I'm very very suspicious. Cecilia

 

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URL: http://www.dr-bob.org/babble/20050921/msgs/557803.html