Lurasidone

FDA Drug Profile

Lurasidone is listed in the FDA National Drug Code directory with 2 NDC codes. Available dosage form: powder.

Drug Details

Generic Name
Lurasidone
Brand Names
N/A
Application Number
Sponsor
MSN Pharmachem Private Limited
NDC Codes
2
Dosage Forms
POWDER
Routes
N/A
Active Ingredients
LURASIDONE, LURASIDONE HYDROCHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE Lurasidone hydrochloride tablets are indicated for: Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia [see Clinical Studies ( 14.1 )] . Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies ( 14.2 )] . Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies ( 14.2 )] . Lurasidone hydrochloride is an atypical antipsychotic indicated for the treatment of: Schizophrenia in adults and adolescents (13 to 17 years) ( 1 , 14.1 ) Depressive episode associated with Bipolar I Disorder (bipolar depression) in adults and pediatric patients (10 to 17 years) as monotherapy ( 1 , 14.2 ) Depressive episode associated with Bipolar I Disorder (bipolar depression) in adults as adjunctive therapy with lithium or valproate ( 1 , 14.2 )