Posted by jrbecker76 on July 25, 2007, at 20:32:34
In reply to Re: When is Gepirone approval due? » jrbecker76, posted by Maria3667 on July 25, 2007, at 8:23:15
Well, I'm not sure how confident GSK is about approval. This quote is from today's GSK 2nd qtr presentation. It's not clear how pessimistic an outlook this is, and whether or not this refers to GSK's perspective on it or just financial analysts'.
"Gepirone ER has potential to be the first of a new class of antidepressants with no risk of sexual side effects or weight issues that many of the other antidepressants have. The FDA has accepted the file for review, and we'll know something by around November 2nd. While I don't think this is in many of the forecast models, this would be a nice upside if it's approved."
http://seekingalpha.com/article/42321> Hi Jr,
>
> Thanks for relaying this info to us. This is what I wanted to know. So in all fairness, if the approval goes through we could say that Gepirone is available on the US-market in approx Feb/March 2008??
>
> My best,
> Maria
>
> > Because it is being re-submitted, also known as a sNDA, the timeline the FDA has to respond is 6 mo from the FDA acceptance date (this is not always the same as the drug company's submission date since the FDA can sometimes take up to 1 month to accept an application). However, according to Fabre-Kramer/GSK, this roughly took place in May, so look for initial word in December. Of course, there is always the chance of further push-backs of the approval decision (e.g., "approvable" but not approved), but this is probably not likely with a sNDA submission. Once an approval takes place, it takes a pharm company approximately another 1-3 month to launch the drug. If you want to track progress on this situation, I would suggest you tune into GSK's quarterly reports/presentations for updates.
> >
> >
> >
> > > Phillipa,
> > >
> > > You are beating around the wrong bush.
> > > Like I said in my initial post, they REFILED in May THIS YEAR after completing an additional set of trials.
> > >
> > > My question is: how long does it take the FDA to evaluate a new medicine from start to finish?
> > >
> > > Here is some info:
> > > http://www.medicalnewstoday.com/articles/70339.php
> > >
> > > My best,
> > > Maria
> > >
> > > > This seems pretty old all I could find right now Love Phillipa
> > > >
> > > > Organon to withdraw gepirone NDA: Organon is planning to withdraw the NDA for its antidepressant gepirone ER following the receipt of a second "not approvable" letter from FDA on June 23. The company submitted additional data in December 2003, and planned to market the drug as Variza. FDA's response likely relates to efficacy concerns, which were cited in the first "not approvable" letter in April 2002. Organon had been counting on gepirone (along with the contraceptive Implanon) as one of two major launches in 2004
> > >
> > >
> >
> >
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poster:jrbecker76
thread:771351
URL: http://www.dr-bob.org/babble/20070719/msgs/771989.html