olanzapine and samidorphan l-malate

FDA Drug Profile

Drug Details

Generic Name
olanzapine and samidorphan l-malate
Brand Names
N/A
Application Number
Sponsor
Alkermes, Inc.
NDC Codes
4
Dosage Forms
TABLET, FILM COATED
Routes
N/A
Active Ingredients
OLANZAPINE, SAMIDORPHAN L-MALATE

Indications and Usage

1 INDICATIONS AND USAGE LYBALVI is indicated for the treatment of: Schizophrenia in adults Bipolar I disorder in adults Acute treatment of manic or mixed episodes as monotherapy and as adjunct to lithium or valproate Maintenance monotherapy treatment LYBALVI is a combination of olanzapine, an atypical antipsychotic, and samidorphan, an opioid antagonist, indicated for the treatment of: Schizophrenia in adults ( 1 ) Bipolar I disorder in adults ( 1 ) Acute treatment of manic or mixed episodes as monotherapy and as adjunct to lithium or valproate Maintenance monotherapy treatment