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Re: agomelatine (Valdoxan) - Application to FDA?

Posted by Larry C on September 4, 2006, at 22:06:59

In reply to Re: agomelatine (Valdoxan) - Application to FDA?, posted by SLS on April 11, 2006, at 10:33:48

Bad news, Valdoxan's application was rejected by the European Union on August 14, 2006.

The EU said that Servier didn't prove Valdoxan's long-term effectiveness.

The short-term studies did show benefit.

The EU was not concerned about Valdoxan's side-effects.

I don't know how this will affect Servier's deal with Novartis for North Ameican distribution.

I wouldn't hold my breath waiting for this to be marketed in North America.

Oh well.

> > Crap!!! I thought this drug was going to be released this year!!!!!!!!!!!!
> >
> > As for the above signing. I believe that just means that they can now START clinical trials in the U.S. if they want. But who knows when. Crap, Crap, Crap!
> Agomelatine (Valdoxan) should become available soon in Europe if it isn't already.
> - Scott




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