Posted by michael on October 18, 2005, at 15:22:52
In reply to FDA panel to review EMSAM on Oct 25th, posted by jrbecker on September 16, 2005, at 15:31:54
Does anyone know what this Oct. 25 meeting means / implies with respect to when the patch might actually reach the market? [and US?]
... the last I heard was someone here estimating that some time around Thanksgiving, Emsam would finally be "available". Does this meeting imply a delay to that time line?
Anybody familiar enough with the workings of the FDA to explain/guess where the patch ultimately IS - with respect to "the end" of this process?
Thanks for any feedback / insights.
michael
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> http://www.fdaadvisorycommittee.com/FDC/AdvisoryCommittee/Stories/102505_chronicA.htm
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> Psychopharmacologic Drugs Advisory Committee To Review Need For Longer-Term Efficacy Data
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> FDA’s Psychopharmacologic Drugs Advisory Committee will meet Oct. 25 to discuss the need for longer-term efficacy data for proposed drug treatments for chronic psychiatric disorders and optimal study designs for obtaining valid information about longer-term benefits of drug treatment.
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> On Oct. 26 the committee will discuss whether or not dietary restrictions should be imposed on Somerset’s depression therapy Emsam (selegiline).
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> To watch a webcast of this meeting, click the button below. To arrange for live videoconferencing, or to order videotapes & DVDs, email webcasthelp@elsevier.com or call 800-627-8171.
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> Posted: Friday, September 16, 2005
poster:michael
thread:555724
URL: http://www.dr-bob.org/babble/20051017/msgs/568585.html