Posted by jhj on September 15, 2007, at 2:59:12
In reply to valdoxan, posted by saturn on September 14, 2007, at 20:46:15
Novartis,which holds US licence for the drug says on its website that it plans to file NDA with FDA next year.EU resubmission for approval is likely to be filed at the end of this year or at the begining of the next year after it was refused approval last year by EMEA.Many studies have shown efficacy of valdoxan or agomelatine in treating depression.It has shown to be atleast as effective as current antidepressants with remarkabley benign side effects.Drop out rates due to side effects in the studies have been found not worse then placebo in controlled studies.Something is really wrong with EMEA and that is why it refused approval of valdoxan.
poster:jhj
thread:782960
URL: http://www.dr-bob.org/babble/20070911/msgs/783013.html