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FDA Approves J&J' Caplyta As Add-On Therapy For Major Depressive Disorder In Adults

By RTTNews Staff Writer   ✉   | Published:   | Follow Us On Google News

Johnson & Johnson (JNJ) on Thursday announced that the U.S. Food and Drug Administration (FDA) has approved Caplyta as an add-on therapy with antidepressants for the treatment of major depressive disorder (MDD) in adults.

The approval was supported by two Phase 3 studies that met their primary endpoints, showing statistically significant and clinically meaningful improvements in depression symptoms compared with an oral antidepressant plus placebo.

Caplyta is already approved for bipolar I and II depression as well as for schizophrenia in adults.

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