Posted by Larry Hoover on May 14, 2005, at 12:39:29
In reply to Re: ....patent expired » Larry Hoover, posted by chemist on May 14, 2005, at 5:57:36
> hi 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
Indeed, and what I found frustrating, is that with all the commentary vis a vis Emsam vs. Eldepryl, I can find no supplemental application.
Serafem and Prozac have the same NDA code number, but appended is a supplemental application code, and so on.
I cannot find an original NDA for Eldepryl (or any other product form of selegiline) that has a supplemental indication application pending, or correspondence about such a thing.
I appreciate that such correspondence is probably confidential, at this stage in the game, but if you search on the VNS device application, you see all kinds of "intermediate" correspondence, leading towards the (hoped for) approval. Nothing similar for Emsam, that I can find.
Lar
poster:Larry Hoover
thread:496583
URL: http://www.dr-bob.org/babble/20050510/msgs/497695.html