Posted by Michael Wonder on 22 Aug 2017
Alkermes initiates rolling submission of ALKS 5461 new drug application for major depressive disorder
21 August 2017 - Company expects to complete submission for fast track designated medicine by year-end 2017.
Alkermes today announced the initiation of its rolling submission of a new drug application to the U.S. FDA, seeking marketing approval of ALKS 5461, a once-daily, oral investigational medicine with a novel mechanism of action, for the adjunctive treatment of major depressive disorder.
The company expects to complete the submission of the new drug application for this fast track designated medicine by year-end 2017.
