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Re: Agomelatine morganator

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.

 

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