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Re: When will Agomelatine be available in the US

Posted by jrbecker76 on May 20, 2009, at 10:04:39

In reply to When will Agomelatine be available in the US, posted by Bob12 on May 20, 2009, at 9:35:26

> Hi,
> Does anyone know when Agomelatine will be available in the US?
>
> thanks
> Bob

Phase III testing is still ongoing here in the States. Novartis has been delayed in finishing these trials. Not sure what this means about what sort of trial results they are achieving. Suffice it to say though that we have at least a year and a half or more should Novartis submit a NDA to the FDA this year (which now seems somewhat doubtful). The slightly good news is that it is now being launched in the wider EU this summer.

JB


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poster:jrbecker76 thread:896778
URL: http://www.dr-bob.org/babble/20090515/msgs/896787.html