=Alkermes (ALKS) : FDA has accepted for review the NDA for ALKS 5461

Alkermes announces that the FDA has accepted for review the NDA for ALKS 5461 for the adjunctive treatment of major depressive disorder in patients with an inadequate response to standard antidepressant therapies 

• FDA's acceptance of the ALKS 5461 NDA and rescission of the Refusal to File letter issued March 30, 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.
• FDA's target action date for the ALKS 5461 NDA is Jan. 31, 2019.