Posted by Maria3667 on July 24, 2007, at 3:42:03
In reply to Re: When is Gepirone approval due?, posted by Phillipa on July 23, 2007, at 21:08:20
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.phpMy 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
poster:Maria3667
thread:771351
URL: http://www.dr-bob.org/babble/20070719/msgs/771560.html