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# Sunovion sNDA for Expanded Latuda Use in Bipolar Disorder
- URL: https://www.fdaweb.com/sunovion-snda-for-expanded-latuda-use-in-bipolar-disorder/
- Published: 2017-06-30T12:00:00.000Z
- Updated: 2026-09-14T22:32:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139073

FDA has accepted for review a Sunovion Pharmaceuticals supplemental NDA for the expanded use of Latuda (lurasidone HCl) in children and adolescents (10 to 17 years of age) with major depressive episodes associated with bipolar 1 disorder (bipolar depression) as monotherapy. Latuda is currently indicated in the U.S. for the treatment of adults with bipolar depression as monotherapy and as adjunctive therapy with lithium or valproate and for the treatment of schizophrenia in adults and adolescents (13 to 17 years of age).

  
The submission is supported by data from a Phase 3 clinical study of children and adolescents with bipolar depression. Data demonstrated that Latuda was associated with statistically significant and clinically meaningful improvement in depressive symptoms compared to placebo, and was generally well-tolerated with few effects on weight and metabolic parameters, the company says.