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Re: agomelatine (Valdoxan) - Application to FDA? » SLS

Posted by jrbecker on April 5, 2005, at 21:46:19

In reply to agomelatine (Valdoxan) - Application to FDA?, posted by SLS on April 4, 2005, at 23:25:36

> I am confused by some of the stuff I read on the Internet regarding the status of agomelatine. Most sites describe this drug as being in phase III, but in phase III where? One website states that agomelatine is in phase III, but that the drug company has not applied to the FDA for approval - only in the European Union.
>
> Does anyone know what's going on with this drug?
>
>
> - Scott

I think I am at fault for part of this confusion. On my drug link, I listed Valdoxan as being submitted to the EU for approval. However, what was really the case is that Servier (the pharm company) has submitted the drug for "centralised registration," and not approval yet.

http://www.servier.com/groupe/fruits.asp

Centralised registration is the closest equivalent to the FDA's "Investigational New Drug (IND)" process, which usually takes place sometime during mid-phase clinical trials.

To clarify, it is still in phase III -- and has been so for at least a year and a half now from what I can recall (perhaps longer).


recent press release:
http://www.medicalnewstoday.com/medicalnews.php?newsid=22334

Unfortunately, Servier doesn't really provide a lot of updates on what's going with this compound. But I will provide any timely news I can uncover. Apologies for this slip-up. I know quite a few of you were anticipating its release.

JB


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