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Re: Transdermal selegiline (EMSAM) marked approvable

Posted by SLS on February 3, 2004, at 14:51:22

In reply to Re: Transdermal selegiline (EMSAM) marked approvable » jrbecker, posted by noa on February 3, 2004, at 12:14:18

> Hmm...I don't know the lingo well enough. "Approvable"---it seems to imply that they passed one hurdle and are moving on to the next

Hi Noa.

I think "approvable" means that it passed the tests for safety and efficacy. No more studies are needed. Usually, there are some issues with wording of the label and manufacturing facility. This is what has hindered Lilly from marketing duloxetine (Cymbalta).


- Scott

 

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URL: http://www.dr-bob.org/babble/20040131/msgs/308942.html