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17 Nov 2020

Alkermes Receives FDA Complete Response Letter Related to ALKS 3831 Manufacturing Records Review

Author: admintech | Filed under: Press Release

DUBLIN, Nov. 17, 2020 /PRNewswire/ — Alkermes plc (Nasdaq: ALKS) today announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ALKS 3831 (olanzapine/samidorphan) for the treatment of adults…