Posted by Maria3667 on July 2, 2007, at 14:47:30
In reply to oops., posted by iforgotmypassword on June 16, 2007, at 1:07:18
Hi Ifogot,
As far as I know the manufacturer Fabre-Kramer has refiled it's application for Gepirone with the FDA last May.
This press release says it all!
Fabre-Kramer refiles to OK antidepressant
HOUSTON, May 8 (UPI) -- Fabre-Kramer said Tuesday it refiled its new drug application for the antidepressant gepirone ER with the U.S. Food and Drug Administration.
The firm said the NDA includes an amendment responding to the FDA's 2004 request for an additional trial for gepirone ER. Fabre-Kramer is seeking an indication for the treatment of major depressive disorder.If gepirone ER ultimately wins approval, GlaxoSmithKline will co-market it worldwide, pursuant to an agreement Fabre-Kramer entered into with the pharmaceutical giant in February.
Fabre-Kramer acquired the rights to gepirone ER in 2005 from Organon after the FDA deemed the drug not approvable in 2004. Under the terms of that agreement, Organon will receive milestone and royalty payments if gepirone ER gets approved.
poster:Maria3667
thread:763519
URL: http://www.dr-bob.org/babble/20070630/msgs/767187.html