Lurasidone
Drug Details
- Generic Name
- Lurasidone
- Brand Names
- N/A
- Application Number
- Sponsor
- Zydus Lifesciences Limited
- NDC Codes
- 2
- Dosage Forms
- POWDER
- Routes
- N/A
- Active Ingredients
- LURASIDONE HYDROCHLORIDE, LURASIDONE
Indications and Usage
1 INDICATIONS AND USAGE Lurasidone hydrochloride tablets are indicated for: 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: 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)