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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 8 of 8. This is the beginning of the thread.
Posted by jms600 on October 30, 2005, at 16:19:42
Hi everyone,
Has anyone any idea when EMSAM / transdermal Selegiline will be available?
Will it be out in the UK?
Thanks!
Posted by rvanson on October 31, 2005, at 13:30:44
In reply to EMSAM / Selegiline - When will it be out?, posted by jms600 on October 30, 2005, at 16:19:42
> Hi everyone,
>
> Has anyone any idea when EMSAM / transdermal Selegiline will be available?
>
> Will it be out in the UK?
>
> Thanks!
It wont be.FDA just ruled it out and NHS follows suit.
Posted by linkadge on October 31, 2005, at 19:06:05
In reply to Re: EMSAM / Selegiline - When will it be out?, posted by rvanson on October 31, 2005, at 13:30:44
Really? The last I heard, they were debating weather dietary restrictions needed to be added to the package labling or not.
Linkadge
Posted by Larry Hoover on October 31, 2005, at 19:59:58
In reply to Re: EMSAM / Selegiline - When will it be out?, posted by linkadge on October 31, 2005, at 19:06:05
> Really? The last I heard, they were debating weather dietary restrictions needed to be added to the package labling or not.
>
> LinkadgeIt's a confusing process, no doubt. The Psychopharmacologic Drugs Advisory Committee, a part of the FDA approval process, met and voted on the issue October 26.
The FDA's Clinical Review expert (Dubitsky) would be reporting to that committee a recommendation to not approve Emsam without warnings.
The committee decided that the 20 mg Emsam patch could be marketed without a tyramine advisory/food restriction guideline, while the 30 mg and 40 mg doses would require warnings.
This is the PDAC committee view, not the final FDA ruling. That might be expected in the next 4 to 6 weeks. Usually, PDAC decisions are adopted as final rules, but not always.
Lar
Posted by willyee on November 1, 2005, at 18:16:14
In reply to Re: EMSAM / Selegiline - When will it be out? » linkadge, posted by Larry Hoover on October 31, 2005, at 19:59:58
So where agreeing here there has been no NO to the drug,just more time in its debut process? Correct?
Posted by Larry Hoover on November 3, 2005, at 8:33:13
In reply to Re: EMSAM / Selegiline - When will it be out?, posted by willyee on November 1, 2005, at 18:16:14
> So where agreeing here there has been no NO to the drug,just more time in its debut process? Correct?
Correct. If it goes to the final ruling as it now stands, 20 mg Emsam patch will have no black box food warning, but 30 and 40 mg patches will.
Posted by willyee on November 3, 2005, at 18:45:01
In reply to Re: EMSAM / Selegiline - When will it be out? » willyee, posted by Larry Hoover on November 3, 2005, at 8:33:13
Man i hope this is a break for many of us,oh i hope sooooo,line me up for the guinea pig oink oink.
Posted by lemon68 on November 3, 2005, at 23:11:18
In reply to Re: EMSAM / Selegiline - When will it be out?, posted by willyee on November 3, 2005, at 18:45:01
Just curious - people on this board have been talking a lot about this patch. Does anyone have any info as to its effectiveness and its advantages over other MAOIs or ADs in general?
thanx
This is the end of the thread.
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