Drugs in the Pipeline FDA Issues Complete Response Letter for Olanzapine/Samidorphan Publish Date November 18, 2020 While the CRL did not raise clinical concerns, the Agency noted that certain conditions related to the tablet coating process needed to be resolved.
Drugs in the Pipeline FDA Committees Vote on Novel Therapy for Schizophrenia, Bipolar I Disorder Publish Date October 13, 2020 ALKS 3831 is composed of samidorphan, a mu-opioid receptor antagonist, which is co-formulated with the established antipsychotic agent, olanzapine, in a single bilayer tablet.