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Re: Selegiline Patch? FDA throws spanner in works.

Posted by michael on March 31, 2002, at 14:41:50

In reply to Selegiline Patch? FDA throws spanner in works. OldSchool, posted by JahL on March 31, 2002, at 11:52:19

> FDA have deemed EMSAM to be 'NOT APPROVABLE'. Tossers.
>
> http://biz.yahoo.com/rf/020327/n27633392_1.html
>
> J.
>
>
> +++++++++++++++++++++++++++++++++++

'Watson said the agency determined that the patch, called Emsam, isn't approvable unless the companies came up with more data showing it works. Somerset has scheduled a meeting with FDA officials. '

Ironic, given some of the "testimonials" seen here...

I know that some of us have experience working with the FDA, or knowledge regarding how the FDA works (or doesn't work - unenthusiastic ha ha)... Does anyone have a feel for EMSAM's future prospects? Delay, vs. Doom?

Just looking for an informed opinion and/or educated guess... Thanks
michael


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poster:michael thread:87632
URL: http://www.dr-bob.org/babble/20020327/msgs/101143.html