Posted by andys on October 10, 2002, at 10:35:57
Several news articles have estimated end of December for final approval by the FDA.
Evidently, the FDA has made aripiprazole "approvable", and the story is that it's a matter of the FDA and Bristol-Meyers deciding on the final language for the drug insert, before it is approved. The story I have heard is that the drug is so clean (side effects), that Bristol wanted very minimal side effects statements. However, the FDA wants to add a warning about akathisia (urge to move), which showed up, even at mid-doses, in some patients. So final approval is stalled out, pending their negotiations on language. (for specifics on akathisia warning: http://www.namiscc.org/newsletters/February02/aripiprazole.htm ).
poster:andys
thread:123063
URL: http://www.dr-bob.org/babble/20021006/msgs/123063.html