Posted by Michael Wonder on 18 Nov 2020
Alkermes receives FDA complete response letter related to ALKS 3831 manufacturing records review
17 November 2020 - No clinical efficacy or safety issues raised and no further studies required by FDA to support approval.
Alkermes today announced that it received a complete response letter from the U.S. FDA regarding its new drug application for ALKS 3831 (olanzapine/samidorphan) for the treatment of adults with schizophrenia and adults with bipolar I disorder.
