I know Novartis has the US rights to this drug. It has been approved in Europe. What is its status as the FDA?
Anyone have an update on Valdoxan? (agomelatine)
- Thread starter Anonymous
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Still a year or so to go in the US yet.
http://www.neurotransmitter.net/newdrugs.html
Has recently been approved in Europe, should be widely available in 2009.
http://www.emea.europa.eu/pdfs/human/opinion/Valdoxan_57541108en.pdf
Interestingly enough agomelatine is approved in the Ukraine where it has been available since 2007.
http://www.neurotransmitter.net/newdrugs.html
Has recently been approved in Europe, should be widely available in 2009.
http://www.emea.europa.eu/pdfs/human/opinion/Valdoxan_57541108en.pdf
Interestingly enough agomelatine is approved in the Ukraine where it has been available since 2007.
Still a year or so to go in the US yet.
http://www.neurotransmitter.net/newdrugs.html
Has recently been approved in Europe, should be widely available in 2009.
http://www.emea.europa.eu/pdfs/human/opinion/Valdoxan_57541108en.pdf
Interestingly enough agomelatine is approved in the Ukraine where it has been available since 2007.
any update on this one?
Why is it dead, I can not find that answer anywhere. It is prescribed in Canada and Europek what did the Novartis trial find?
The oral had liver toxicity. Tried sublingual, had efficacy issues, swollen tongue amongst other side effects. Didn't even show the evidence to the FDA. We just said, screw it, no chance. It has officially been dropped from our Best in Class pipeline.