Posted by sfy on January 27, 2005, at 12:17:24
In reply to Re: Segeline Patch - it is approved!!, posted by bipolarspectrum on January 27, 2005, at 10:59:29
> Hi,
> THe selegiline patch was approved by the FDA last year... but the company that produces it is small, based in florida, and unable to distribute it on its own.. but it recently signed a contract with a bigger company to help produce and distribute it... I would think it would be out by this summer at the latest..
> bps
> ps. u can find out about this contract between the two companies somewhere on the web, i believe at somersetpharm.com or somethign like thatNot exactly - the EMSAM patch received an "approvable letter" from the FDA which, I believe, is the last step right before final approval. The remaining issue seems to be on the dietary restrictions. The manufacturer wants to market without the usual MAOI dietary restrictions (otherwise there is no benefit to the patch over other MAOI's). The FDA was hedging on this and wanted more data in support of this position. Most of the studies were conducted (for treating major depression, by the way) without any dietary restrictions with no ill effects. So, right now, it's just a waiting game for the FDA to finish its review.
The EMSAM patch is produced by Somerset Pharmaceuticals, a joint venture of Mylan Laboratories and Watson Pharmaceuticals - two large generic drug manufacturers perfectly capable of distributing the patch on their own. Somerset recently signed a deal with Bristol-Myers Squibb to market the patch thus giving them additional assistance in publicizing the patch.
poster:sfy
thread:448571
URL: http://www.dr-bob.org/babble/20050124/msgs/448641.html