Benzinga | Jun 1, 2021 07:02AM EDT

Alkermes Announces FDA Approval Of LYBALVI For Treatment Of Schizophrenia And Bipolar I Disorder

Alkermes plc (NASDAQ:ALKS) today announced that the U.S. Food and Drug Administration (FDA) has approved LYBALVI(tm) (olanzapine and samidorphan) for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder, as a maintenance monotherapy or for the acute treatment of manic or mixed episodes, as monotherapy or an adjunct to lithium or valproate. LYBALVI is a once-daily, oral atypical antipsychotic composed of olanzapine, an established antipsychotic agent, and samidorphan, a new chemical entity.