Lurasidone
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: • 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 tablets are 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 )