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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 2 of 2. This is the beginning of the thread.
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.
Posted by Bob on September 16, 2002, at 23:01:08
In reply to 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.That's good news. I'm wondering whether duloxetine will have an extreme withdrawal syndrome like Effexor, though? I hope not, otherwise I wouldn't touch it.
This is the end of the thread.
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