 The FDA has approved Alkermes plcs NASDAQ: ALKS Lybalvi, a once-daily, oral atypical antipsychotic composed of olanzapine, an established antipsychotic agent, and samidorphan, a new chemical entity, for schizophrenia and bipolar I disorder. The approval comes as a maintenance monotherapy or for the acute treatment of manic or mixed episodes, as monotherapy or an adjunct to lithium or valproate. 