Posted by Ron Hill on July 2, 2010, at 0:01:42
In reply to Re: Agomelatine add-on to Nardil » Ron Hill, posted by Bob on July 1, 2010, at 22:37:37
> 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
poster:Ron Hill
thread:952388
URL: http://www.dr-bob.org/babble/20100628/msgs/952910.html