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Alkermes Announces FDA Acceptance for Review of New Drug Application for ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder

06:50 EDT 16 Apr 2018 | Alkermes plc

-- FDA Action Expected by Jan. 31, 2019 -- -- Conference Call Scheduled for Today at 8:30 a.m. ET -- DUBLIN, April 16, 2018 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (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 (MDD) in patients with an inadequate response to standard antidepressant therapies. FDA's target action date for the ALKS 5461 NDA is Jan. 31, 2019. FDA's acceptance of the ALKS 5461 NDA and rescission of the Refusal to File letter issued March 30, 2018 follows productive inte...

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