Lurasidone HCl

FDA Drug Profile

Drug Details

Generic Name
Lurasidone HCl
Brand Names
N/A
Application Number
Sponsor
Aurobindo Pharma Limited
NDC Codes
2
Dosage Forms
POWDER
Routes
N/A
Active Ingredients
LURASIDONE HYDROCHLORIDE

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)].