Posted by Larry Hoover on October 31, 2005, at 19:59:58
In reply to Re: EMSAM / Selegiline - When will it be out?, posted by linkadge on October 31, 2005, at 19:06:05
> Really? The last I heard, they were debating weather dietary restrictions needed to be added to the package labling or not.
>
> LinkadgeIt's a confusing process, no doubt. The Psychopharmacologic Drugs Advisory Committee, a part of the FDA approval process, met and voted on the issue October 26.
The FDA's Clinical Review expert (Dubitsky) would be reporting to that committee a recommendation to not approve Emsam without warnings.
The committee decided that the 20 mg Emsam patch could be marketed without a tyramine advisory/food restriction guideline, while the 30 mg and 40 mg doses would require warnings.
This is the PDAC committee view, not the final FDA ruling. That might be expected in the next 4 to 6 weeks. Usually, PDAC decisions are adopted as final rules, but not always.
Lar
poster:Larry Hoover
thread:573480
URL: http://www.dr-bob.org/babble/20051031/msgs/573923.html