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."
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.