Posted by chemist on May 14, 2005, at 5:57:36
In reply to Re: ....patent expired » chemist, posted by Larry Hoover on May 12, 2005, at 22:56:00
> http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
> >
> > which is easily reached (CDER Archives) from www.fda.gov. there, you can actually locate the drug Eldepryl, and learn about the NDA/ANDA/BLA business (and other meaningful acronyms), and make an informed decision.
>
> I see all kinds of ANDA applications approved in the period of 96-98. Obviously, the stuff is off patent. Does the delivery system make Emsam a new drug?
>
> If I'm not mistaken, the transdermal route is supposed to avoid first-pass metabolism, and thus avoid the whole tyramine thing (i.e. the protective enzymes in the gut are spared, leaving them "on guard" against ingested tyramine). Is it that this mechanism isn't proved? Or that nobody wants to stick their neck out in this particular legal/political climate? It's not a medical issue, is it? I don't think so.
>
> And so, I leave loose ends, and off to bed.
>
> Larhi larry et al...the regulatory framework in place at the FDA does allow a company to secure a patent - exclusive, at that - for a drug that is shown to be effective in treating conditions for which it was not orignally approved, yes: hence, the prozac/serafem business, and the wellbutrin/zyban business. this list goes on and on. the delivery mechanism does not warrant an NDA or IND; the antidepressant status vs. the antiparkinsonian does. prozac (AD) is under patent as Serafem which is indicated in treating something known as PMDD; wellbutrin is an AD, while zyban is indicated for smoking cessation.....yours, c
poster:chemist
thread:496583
URL: http://www.dr-bob.org/babble/20050510/msgs/497643.html