Posted by Bob on July 2, 2010, at 1:22:46
In reply to Re: Agomelatine add-on to Nardil » Bob, posted by Ron Hill on July 2, 2010, at 0:01:42
> > Agomelatine is not available in the US, right?
>
> Bob,
>
> You are correct. In the U.S., Novartis has conducted six Phase III trials as an antidepressant. However, the results were less than stellar.
>
> Therefore, Novartis is conducting more Phase III tests prior to submission to the U.S. FDA. Novartis expects agomelatine to be available in the U.S. sometime in 2012.
>
> But, in answer to what I think is the heart of your question, the U.S. FDA allows the import of overseas medications in three month lots. Any p-doc can order a three months supply of an overseas medication, like Valdoxan (i.e.; agomelatine). Then, in three months the p-doc can order another three months supply, and-on-and-on.
>
> -- Ron
>
Ron-Wow, 6 phase III trials? It sounds like the efficacy is questionable. I don't understand how drug after drug like this one get approved in
Europe but then don't make it to approval over here.I wasn't aware that a 3-month supply could be obtained from my doctor like that. Thanks for the info.
-Bob
poster:Bob
thread:952388
URL: http://www.dr-bob.org/babble/20100628/msgs/952921.html