Posted by chemist on May 15, 2005, at 2:44:48
In reply to Re: ....patent expired » chemist, posted by Larry Hoover on May 14, 2005, at 12:39:29
> > 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
>hi larry, i posted a windy reply to this hours ago, yet i must have ditched it...if you go to the 2003 archives of CDER, you will find the NDA # for Eldepryl, and in the 1997 archive, mention of - but no links that work (for me) - three (3) supplemental notations, likely the labeling and other changes. it appears that emsam is a ghost or a well-kept secret. i am not aware of any reason why sundry letters would be held by the FDA/other...the closest thought i ahve - not borned by limited experience - is that if a drug is about to fill the shelves, then a media blackout from the gov't is warranted as it might fuel trading in financial markets. just a guess, and the NDA # for Eldepryl is 020647, approved 05/15/1996, labeling revision 08/06/1997, and control supplement 02/15/2001. the NDA went to somerset, and therapeutic equivs for aaipharma, clonmel, and torpharm are given, although the reference - somerset's 5 mg selegiline HCl oral tablet - is TE == AB (unusual), and the generics are AB (par for the course...)....a mystery indeed...yours, c
poster:chemist
thread:496583
URL: http://www.dr-bob.org/babble/20050510/msgs/497930.html