Posted by ravenstorm on August 25, 2004, at 10:25:43
In reply to Re: selegiline transdermally » poop'd-out, posted by SLS on August 25, 2004, at 7:30:41
I read somewhere that an anouncement about ensam should be coming through sometime in August.
Anybody heard anything yet??
I know they are wrangling with the FDA over whether or not the patch will be labeled as needing food restrictions or not. The company (is it Watson?) is claiming food restrictions are not needed (which makes sense to me) but the FDA is apparently requiring more proof of this.
My fear is that if the FDA only agrees to approve the drug WITH food restrictions, that Watson won't ever find a manufacturer for the drug because the perceived profit for "just another MAOI" will be too dismal.
Keeping all my fingers and toes crossed.
poster:ravenstorm
thread:381095
URL: http://www.dr-bob.org/babble/20040825/msgs/382097.html