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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 6 of 6. This is the beginning of the thread.
Posted by morganator on August 13, 2009, at 22:30:25
Anyone know how close the FDA is to approving Agomelatine??? Sorry if I missed anything in previous discussions of this new drug.
Posted by Netch on August 14, 2009, at 6:14:01
In reply to Agomelatine, posted by morganator on August 13, 2009, at 22:30:25
Novartis is delaying Agomelatine in the US:
"AGO178 (agomelatine), a once-daily investigational treatment for
patients with major depression, will be studied in additional Phase
III trials to further explore the benefit/risk and pharmacokinetic
profile of this compound. A recent review of data from previous Phase
III trials confirmed the known efficacy and safety profile of the
drug. Submission for US regulatory approval, which had been
anticipated in 2009, is now expected in 2012. The US rights to this
compound were acquired in March 2006 from Servier."http://english.capital.gr/news.asp?id=776685
> Anyone know how close the FDA is to approving Agomelatine??? Sorry if I missed anything in previous discussions of this new drug.
Posted by morganator on August 14, 2009, at 17:13:58
In reply to Re: Agomelatine » morganator, posted by Netch on August 14, 2009, at 6:14:01
> Novartis is delaying Agomelatine in the US:
>
> "AGO178 (agomelatine), a once-daily investigational treatment for
> patients with major depression, will be studied in additional Phase
> III trials to further explore the benefit/risk and pharmacokinetic
> profile of this compound. A recent review of data from previous Phase
> III trials confirmed the known efficacy and safety profile of the
> drug. Submission for US regulatory approval, which had been
> anticipated in 2009, is now expected in 2012. The US rights to this
> compound were acquired in March 2006 from Servier."
>
> http://english.capital.gr/news.asp?id=776685
>
Why????? So wait, seriously, 2012???
>
>
> > Anyone know how close the FDA is to approving Agomelatine??? Sorry if I missed anything in previous discussions of this new drug.
>
>
Posted by iforgotmypassword on August 14, 2009, at 20:35:40
In reply to Re: Agomelatine, posted by morganator on August 14, 2009, at 17:13:58
SAP: special access programme.
it's run by the federal government to allow the sale of certain unapproved drugs in certain circumstances. i have gotten amisulpride this way. now after a long wait (due to the company's own song and dance) i have started agomelatine, tonight will be my third at 25mg. the company (Servier) provided the medication itself for free, which has been very helpful to me, as i still cannot work.
unfortunately i am noticing nothing... i expected some immediate 'sign' given the nature of the drug as a direct antagonist and agonist. trying to keep optimistic. not so sure. i probably should have put the extra work in and find out how to get english prescribing info and english speaking contacts for tandospirone...
already the end of the summer. this is a major failure for me. another semestre gone. anyway sorry i am rambling...
Posted by morganator on August 14, 2009, at 21:39:50
In reply to does the US have anything similar to SAP in CAN, posted by iforgotmypassword on August 14, 2009, at 20:35:40
You are not rambling at.
You have only taken Valdoxan for 3 nights? For some it takes up to 2 weeks to really start to benefit from. Also, you may need to bump the dosage up to 50 mgs in a few weeks.
Posted by morganator on August 14, 2009, at 21:57:29
In reply to does the US have anything similar to SAP in CAN, posted by iforgotmypassword on August 14, 2009, at 20:35:40
You are not rambling at.
You have only taken Valdoxan for 3 nights? For some it takes up to 2 weeks to really start to benefit from. Also, you may need to bump the dosage up to 50 mgs in a few weeks.
This is the end of the thread.
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