Posted by pseudonym on October 11, 2004, at 23:55:24
In reply to Pregabalin not really approved in US yet, right?, posted by jaby on October 8, 2004, at 10:31:33
That's correct. Pregabalin is not approved for marketing in the US, yet. Pregabalin received a not-approvable letter for generalized anxiety disorder, which is of course the indication that has the most number of sufferers. However, they did receive an approvable letter for other indications in the U.S., and because Neurontin is going generic, I'm going to hazard a guess that they'll want Lyrica (Pregabalin) on the market sooner rather than later. So, my guess is they'll "give" on the GAD indication in order to get it approved. Then, its up to physicians to determine whether it indeed does not work for GAD, as the FDA must believe.
poster:pseudonym
thread:400347
URL: http://www.dr-bob.org/babble/20041007/msgs/401949.html