Alkermes Announces FDA Approval Of LYBALVI™ For The Treatment Of Schizophrenia & Bipolar I Disorder

Alkermes plc announced that the U.S. Food and Drug Administration (FDA) has approved LYBALVI™ (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. Alkermes expects to make LYBALVI available for consumers in the fourth quarter of 2021.

LYBALVI is a once-daily, oral tablet. It will be available in fixed dosage strengths composed of 10 mg of samidorphan and 5 mg, 10 mg, 15 mg . . .