Cymbalta (Duloxetine) Got It's Approvable Letter

Posted by EarlyWakening on September 16, 2002, at 19:38:25

Duloxetine announced today that it got it's Approvable Letter from the FDA. Final approval is contingent upon labeling discussions (which is very standard), and upon Lilly straightening out it's manufacturing quality-control mess. It amazes me that a pharmaceutical house as large as Lilly could fumble the ball so completely in that regard.
My guess is that duloxetine will not be on store shelves until March.

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Cymbalta (Duloxetine) Got It's Approvable Letter EarlyWakening 9/16/02
Re: Cymbalta (Duloxetine) Got It's Approvable Letter » EarlyWakening Bob 9/16/02

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