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US FDA approves Sumitomo unit's schizophrenia treatment for adolescents

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US FDA approves Sumitomo unit's schizophrenia treatment for adolescents

The U.S. FDA approved Sunovion Pharmaceuticals Inc.'s Latuda for the treatment of schizophrenia in adolescents aged 13 to 17 years.

The FDA's approval of the supplemental new drug application for Latuda was based on the results of a six-week study in which adolescent patients with schizophrenia received fixed doses of Latuda 40 milligrams per day, 80 milligrams per day or a placebo.

Latuda is also U.S. FDA-approved for adults with schizophrenia, major depressive episodes associated with bipolar I disorder as monotherapy, and as adjunctive therapy with lithium or valproate.

Sunovion is a wholly owned unit of Sumitomo Dainippon Pharma Co. Ltd.