Posted by SLS on April 3, 2004, at 10:37:02
In reply to Re: Duloxetine: antidepressant drug trial turns deadly » SLS, posted by jack smith on April 3, 2004, at 2:21:09
Hi Jack.
> >I am eagerly awaiting its arrival.
> I don't think it is ever arriving. . . . Sorry to be a pessimist but with all the bs about AD's in the news lately,That is my fear.
> and the fact that this was supposed to have been approved a year and a half ago with a release date of February 2003 makes me think there is something we don't know about.
It was my understanding that there were only two issues that needed to be resolved before the FDA would grant final approval:
1. The condition of the factory building in which the drug is to be manufactured.
2. The wording of the label (package insert).
It looks like the investigation that used supposedly healthy volunteers in which the suicide occured was to study the pharmacokinetics of duloxetine. I have no idea why they would need to do such a study so late in the approval process.
- Scott
poster:SLS
thread:331801
URL: http://www.dr-bob.org/babble/20040402/msgs/332067.html