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Re: FDA panel to review EMSAM on Oct 25th » jrbecker

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


>
> http://www.fdaadvisorycommittee.com/FDC/AdvisoryCommittee/Stories/102505_chronicA.htm
>
>
> Psychopharmacologic Drugs Advisory Committee To Review Need For Longer-Term Efficacy Data
>
>
> 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.
>
> On Oct. 26 the committee will discuss whether or not dietary restrictions should be imposed on Somerset’s depression therapy Emsam (selegiline).
>
> 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.
>
> Posted: Friday, September 16, 2005


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