Posted by SLS on April 6, 2005, at 17:04:02
In reply to Re: agomelatine (Valdoxan) - Application to FDA? » SLS, posted by jrbecker on April 6, 2005, at 8:52:36
> > Hi JB.
> >
> > I am STILL confused!
> >
> > Has agomelatine been submitted to the U.S. FDA?
> >
> > Thanks.
> >
> >
> > - Scott
> >
>
>
> No.
This is what I found out via a personal communication:"The dossier has been
submitted to the European Medical Evaluation Agency, EMEA, in April 2005 and
we expect the European Registration in 2006. All future registration
procedures in other countries, including the United States, will depend on
the European registration."
- Scott
poster:SLS
thread:479920
URL: http://www.dr-bob.org/babble/20050404/msgs/480812.html