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Alkermes files U.S. marketing application for MDD med ALKS 5461

Published 01/31/2018, 03:02 PM
Updated 01/31/2018, 03:02 PM
© Reuters.  Alkermes files U.S. marketing application for MDD med ALKS 5461
  • Alkermes plc (ALKS -0.1%) completes the filing of its New Drug Application (NDA) to the FDA seeking approval for ALKS 5461 for the adjunctive treatment of major depressive disorder (MDD).
  • The FDA should notify the company whether it has accepted the application for review within ~60 days.
  • Fast Track-tagged ALKS 5461 is a once-daily, orally administered formulation of samidorphan and buprenorphine that is designed to rebalance brain function that is dysregulated in the state of depression.
  • Previously: Alkermes commences rolling NDA submission for MDD med ALKS 5461 (Aug. 21, 2017)
  • Now read: Alkermes: A Solid CNS Portfolio With An Option For Depression


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