Posted by OldSchool on March 30, 2002, at 9:02:56
Well folks, its official. The much hyped "MAOI Patch" was rejected by the FDA. It aint gonna happen. I predicted this...it sounded too good to be true. I knew it would get rejected and turns out, I was right. Why? I have no real idea but can only speculate. Probably the SSRI companies had too much political pull and tried to get it blocked as an MAOI patch might eat into SSRI sales too much. Or maybe the FDA really honestly believed the patch was not effective or unsafe. Also, remember this patch would have been used by people with parkinsons, not just with depression.
All I can say is...what a bunch of shit.Somerset says FDA turns down depression-drug patch
Wednesday March 27, 8:59 PM EST
TAMPA, Fla., March 27 (Reuters) - Somerset Pharmaceuticals Inc., a joint venture of generic drugmakers Mylan Laboratories (MYL) and Watson Pharmaceuticals Inc. (WPI), said on Wednesday that U.S. regulators have rejected its application to market a skin patch for treatment of depression.
Somerset, based in Tampa, Florida, said the U.S. Food and Drug Administration decided that the company's Emsam skin patch, containing the drug selegiline, is not approvable unless there is more data showing that it is effective.
Somerset said it had scheduled a meeting with the FDA to review and clarify the comments and, subject to the meeting, will prepare a response to the agency.
Shares of Mylan, which is based in Pittsburgh, rose 3 cents to close at $30 on the New York Stock Exchange, while shares of Corona, California-based Watson fell 37 cents to close at $30.74.
©2002 Reuters Limited.
poster:OldSchool
thread:100963
URL: http://www.dr-bob.org/babble/20020327/msgs/100963.html