Posted by Michael Wonder on 16 Apr 2018
Alkermes announces FDA acceptance for review of new drug application for ALKS 5461 for the adjunctive treatment of major depressive disorder
16 April 2018 - FDA action expected by 31 January 2019.
Alkermes today announced that the U.S. FDA has accepted for review the new drug application (NDA) for ALKS 5461, a novel, once-daily, oral investigational medicine for the adjunctive treatment of major depressive disorder in patients with an inadequate response to standard antidepressant therapies. FDA's target action date for the ALKS 5461 NDA is 31 January 2019.
FDA's acceptance of the ALKS 5461 NDA and rescission of the Refusal to File letter issued 30 March 2018 follows productive interactions with the Agency in which Alkermes clarified certain aspects of the NDA submission. No additional data or analyses were submitted by Alkermes to FDA.
