Posted by Phillipa on July 23, 2007, at 21:08:20
In reply to Re: When is Gepirone approval due? » Phillipa, posted by Maria3667 on July 23, 2007, at 16:25:56
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:Phillipa
thread:771351
URL: http://www.dr-bob.org/babble/20070719/msgs/771503.html