Posted by Larry Hoover on August 11, 2003, at 4:55:06
In reply to Re: Is anyone taking MOCLOBEMIDE, Manerix » lillypads, posted by cubbybear on August 11, 2003, at 1:26:58
> > I live in Canada.Why is this drug not available in the U.S.?
>
> The story goes that, around the time that the mfr. wanted to market it in the U.S., the SSRIs had hit the scene and were becoming very popular. So the Moc. mfr. tried to have it marketed for social phobia instead of depression but quit the idea after they found out how much it would cost them to get the procedures done for the Food and Drug Admin. (FDA). Some B.S. like that.
> It apparently was a matter of bad timing and consideration of money. That's all I know. Maybe someone else can give you more/more accurate details.I think (I'm not sure) that the FDA requires U.S. efficacy trial data for drugs approved in the U.S. In other words, the European studies are worthless in getting the drug approved. Another factor was the patent had probably been taken out years before the drug was considered in the U.S. market, and the cost of the efficacy trials, in the context of the patent protection period still remaining, made the drug company decide it wasn's worth it.
poster:Larry Hoover
thread:249728
URL: http://www.dr-bob.org/babble/20030807/msgs/249981.html