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Agomelatine is currently being re-examined by the EMEA , after a previous failed attempt by Servier to gain approval in 2006. The concern at the time was that effiicacy for long term treatment of depression had not been demonstated. Recent studies have shown agomelatine is effective in long term treatment of depression and useful in anxiety disorders. The EMEA result is expected in mid 2008, so the drug may be available in Europe in 2009 if there are no problems.
In the USA Novartis has the rights to develop Agomelatine and it is currently in phase III trials, submission to the FDA may occur by the end of 2008. If all goes well I guess end of 2009/2010 for release in the US is likely.
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