Posted by Hygieia's Bowl on August 14, 2008, at 10:34:36
In reply to Bifeprunox not approved, posted by Jeroen on August 14, 2008, at 9:50:06
> Bifeprunox not approved, it was a 3rd generation class like Abilify, now why on earth didnt they approve this ?
From 2007 regarding US FDA:
--- The U.S. Food and Drug Administration informed Solvay and its partner Wyeth Pharmaceuticals (WYE.N: Quote, Profile, Research, Stock Buzz) that efficacy data in tests of the drug -- tipped to be a blockbuster -- were not yet sufficient to allow for approval of the drug.
Furthermore, the FDA asked for further information about the drug and more details about the death of a participant in the trials.
"The Agency also requested further information regarding human metabolism of bifeprunox, and information regarding a complex case of a patient who died while participating in one of the trials," Solvay said in a statement. ---
Just giving FYI that's a year old....
poster:Hygieia's Bowl
thread:846140
URL: http://www.dr-bob.org/babble/20080814/msgs/846152.html