Posted by Larry Hoover on March 28, 2007, at 7:35:51
In reply to Re: generic form of Lamictal, posted by notfred on March 28, 2007, at 0:33:32
> > > No, no generic. I know b/c I tried to find a comparable drug that offers a generic. No generic Lamictal in the US.
> > > Will be a while before there is one..
> >
> > xbunny was correct. Teva is marketing a generic in the U.S., and two other manufacturers will soon do so.
> >
> > Here's the FDA link:
> > http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Overview&DrugName=LAMOTRIGINE
> > short version: http://tinyurl.com/2rn367
> >
> > Lar
>
>
> Here in the states only the generic childrens chewables are on the market. Generic adult tabs are not on the market, yet.Well, I guess there's a difference between obtaining market approval and actually selling the drug. I apologize for assuming that a manufacturer that could sell it was already doing so.
Teva beat GSK on a patent-infringement action, and the CD formulation was cleared first. Teva obtains 180-day market exclusivity for its generic, as they were first out ot the gate with their ANDA applications. They were approved by the FDA last August for their regular lamotrigine formulations. I simply assumed they'd be selling it by now. The 180-day period begins when they release it for sale, so maybe they're just in the stock-piling phase. I'd expect the generic to be available any time now.
http://www.fda.gov/cder/foi/appletter/2006/076388s000ltr.pdf
http://www.fda.gov/cder/foi/appletter/2006/076420s000LTR.pdfLar
P.S. The FDA link in my earlier post didn't work either, so it wasn't tinyurl's fault. Selecting L, then lamotrigine, from the menus gets you to the Teva ANDA application, etc.
poster:Larry Hoover
thread:744534
URL: http://www.dr-bob.org/babble/20070327/msgs/744892.html