lumateperone
Drug Details
- Generic Name
- lumateperone
- Brand Names
- CAPLYTA
- Application Number
- NDA209500
- Sponsor
- Intra-Cellular Therapies, Inc
- NDC Codes
- 4
- Dosage Forms
- CAPSULE
- Routes
- ORAL
- Active Ingredients
- LUMATEPERONE
Indications and Usage
1 INDICATIONS AND USAGE CAPLYTA is indicated for: Treatment of schizophrenia in adults [see Clinical Studies (14.1) ] . Treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults, as monotherapy and as adjunctive therapy with lithium or valproate [see Clinical Studies (14.2) ] . Adjunctive therapy with antidepressants for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies ( 14.3 ) ]. CAPLYTA is an atypical antipsychotic indicated for: Treatment of schizophrenia in adults. ( 1 ) Treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults, as monotherapy and as adjunctive therapy with lithium or valproate. ( 1 ) Adjunctive therapy with antidepressants for the treatment of major depressive disorder (MDD) in adults. ( 1 )