![[dr. bob]](/dr-bob-sm.gif)
Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 4 of 4. This is the beginning of the thread.
Posted by iforgotmypassword on June 16, 2007, at 1:04:03
using the Bristol-Myers Squibb site's search, no new or even old press on gepirone is seems to be kept. i have been periodically searching google news for months, is it fair to guess its abandoned and it's final? looks like it was quite possibly just pointless money/investment focused news...?
:(
Posted by iforgotmypassword on June 16, 2007, at 1:07:18
In reply to gepirone has disappeared again?, posted by iforgotmypassword on June 16, 2007, at 1:04:03
bristol-myers squibb was the last company, now it is glaxo... still would be nice to have some clearer info on if the work towards its release is something we can count on... does anyone know?
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.
Posted by Maria3667 on July 2, 2007, at 14:50:19
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.
This is the end of the thread.
Psycho-Babble Medication | Extras | FAQ
Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.org
Script revised: February 4, 2008
URL: http://www.dr-bob.org/cgi-bin/pb/mget.pl
Copyright 2006-17 Robert Hsiung.
Owned and operated by Dr. Bob LLC and not the University of Chicago.