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Re: FDA Issues Approvable Letter for Eszopiclone

Posted by utopizen on March 4, 2004, at 20:33:48

In reply to FDA Issues Approvable Letter for Eszopiclone, posted by jerrympls on March 3, 2004, at 20:42:15

> After conducting 24 clinical trials involving more than 2,700 adults and elderly patients, Sepracor, Inc. has been sent an "approvable" letter by the US Food and Drug Administration (FDA) for a new hypnotic medication, Estorra (eszopiclone). When final approval is achieved, Estorra will be available by prescription for the treatment of insomnia. According to a report by Sepracor, there will not be limits on the duration of use for this medication.
>

I heard these drugs would come out mid-2005... glad to see they're at least rolling closer to come out!

There is a god. No more black box warnings just because Ambien's maker didn't feeling like proving it wasn't habit forming.

I've literally lost way too much sleep, and now am losing cash monthly ($140) from resorting to buying Ambien online.... and I'm poor, and am in college, and see a sleep psychiatrist, a sleep pulmnologist, and a regular psychiatrist, and let me tell you, the more involved a doc is with sleep, the less they seem to care if you actually sleep.


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