![[dr. bob]](/dr-bob-sm.gif)
Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 3 of 3. This is the beginning of the thread.
Posted by Lorraine on June 25, 2001, at 17:30:30
This was posted at another site. Does anyone have any info?
"
I just learned that Somerset pharmaceuticals filed the New drug
Application with the FDA for the maoi patch on May 25th.I have been waiting for a long time for this since hearing
anecdotalevidence from the trials and was wondering if anyone knew
anything about how long it typically takes for the FDA to review the
drug applications once they are subitted.Could the patch be in Walgreens later this Summer?? or is a year more
likely? "
Posted by Adam on June 26, 2001, at 0:52:54
In reply to Selegiline Patch, posted by Lorraine on June 25, 2001, at 17:30:30
I have but four words for you: Don't hold your breath.
Speaking from semi-personal experience, the FDA is populated by a dilatory bunch, I'm afraid, and their behavior appears to be rather arbitrary at times. Drug approvals can get hung up for any number of reasons, be it the finer points of label wording, or waiting once again for the results of Just One More Trial to allay what is often a less-than-relevant concern held by one panelist.
I don't want to turn this into too much of a rant about the FDA, which does, after all, keep people from selling you rat poison as, say, a laxitive. But I have to believe, by now, given what I've seen myself, the folks at Somerset must be pulling their hair out. Maybe the end is near. Who knows.
I imagine odds are about even they'll get approval at some point, though I wonder if depression will be the indication. The feds may well have been unimpressed and somewhat befuddled by Somerset's "it's the same, only different" spin on selegiline via transdermal delivery. I mean, it's an anti-parkinsonian, right? Now it's an antidepressant? Just because it's in a patch? After all, they're not simply making it easier to take, they're changing it. Sort of. Not really. Kind of. Many a furrowed brow, I'm sure.
> This was posted at another site. Does anyone have any info?
>
> "
> I just learned that Somerset pharmaceuticals filed the New drug
> Application with the FDA for the maoi patch on May 25th.
>
> I have been waiting for a long time for this since hearing
> anecdotalevidence from the trials and was wondering if anyone knew
> anything about how long it typically takes for the FDA to review the
> drug applications once they are subitted.
>
> Could the patch be in Walgreens later this Summer?? or is a year more
> likely? "
Posted by Lorraine on June 26, 2001, at 9:52:27
In reply to Re: Selegiline Patch, posted by Adam on June 26, 2001, at 0:52:54
> I have but four words for you: Don't hold your breath.
>
> Speaking from semi-personal experience, the FDA is populated by a dilatory bunch, I'm afraid, and their behavior appears to be rather arbitrary at times. Drug approvals can get hung up for any number of reasons, be it the finer points of label wording, or waiting once again for the results of Just One More Trial to allay what is often a less-than-relevant concern held by one panelist.
>
> I don't want to turn this into too much of a rant about the FDA, which does, after all, keep people from selling you rat poison as, say, a laxitive. But I have to believe, by now, given what I've seen myself, the folks at Somerset must be pulling their hair out. Maybe the end is near. Who knows.
>
> I imagine odds are about even they'll get approval at some point, though I wonder if depression will be the indication. The feds may well have been unimpressed and somewhat befuddled by Somerset's "it's the same, only different" spin on selegiline via transdermal delivery. I mean, it's an anti-parkinsonian, right? Now it's an antidepressant? Just because it's in a patch? After all, they're not simply making it easier to take, they're changing it. Sort of. Not really. Kind of. Many a furrowed brow, I'm sure.
>
>
> > This was posted at another site. Does anyone have any info?
> >
> > "
> > I just learned that Somerset pharmaceuticals filed the New drug
> > Application with the FDA for the maoi patch on May 25th.
> >
> > I have been waiting for a long time for this since hearing
> > anecdotalevidence from the trials and was wondering if anyone knew
> > anything about how long it typically takes for the FDA to review the
> > drug applications once they are subitted.
> >
> > Could the patch be in Walgreens later this Summer?? or is a year more
> > likely? "
This is the end of the thread.
Psycho-Babble Medication | Extras | FAQ
Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.org
Script revised: February 4, 2008
URL: http://www.dr-bob.org/cgi-bin/pb/mget.pl
Copyright 2006-17 Robert Hsiung.
Owned and operated by Dr. Bob LLC and not the University of Chicago.