Posted by Michael Wonder on 28 Jan 2020
Alkermes announces U.S. FDA acceptance of ALKS 3831 new drug application for treatment of schizophrenia and bipolar I disorder
28 January 2020 - Alkermes today announced that the U.S. FDA has accepted for review the company's new drug application seeking approval of ALKS 3831 (olanzapine/samidorphan) for the treatment of schizophrenia and for the treatment of bipolar I disorder.
ALKS 3831 is an investigational, novel, once-daily, oral atypical antipsychotic drug candidate designed to provide the efficacy of olanzapine while mitigating olanzapine-associated weight gain.
The NDA has been assigned a Prescription Drug User Fee Act target action date of 15 November 2020.
