Johnson & Johnson’s Caplyta gained FDA approval as an adjunctive treatment for major depressive disorder, expanding the label after J&J acquired the asset via its Intra‑Cellular Therapies purchase. The clearance adds a broad psychiatric indication that J&J projected as key to achieving multibillion‑dollar sales forecasts for the drug. The approval strengthens the rationale for the acquisition and gives J&J a growth lever in neuropsychiatry. Company documents cited expected peak annual sales that depend on rapid uptake in major depressive disorder as adjunctive therapy. Clinicians and market watchers will assess how Caplyta’s safety and efficacy profile positions it against existing adjunctive agents and how commercialization resources will be allocated across J&J’s broader CNS portfolio.