Johnson & Johnson received FDA approval expanding the label for Caplyta (originating from Intra‑Cellular Therapies) into adjunctive treatment for major depressive disorder, a regulatory win tied to J&J’s $14.6 billion acquisition of Intra‑Cellular. The approval is positioned as the second major indication expected to drive the therapy toward a multi‑billion dollar revenue goal. Company statements framed the label change as central to commercial plans and to justify the acquisition’s strategic value, citing the expanded patient population and potential for increased uptake in psychiatric practice. The label expansion accelerates J&J’s positioning in neuropsychiatry after the buyout and will factor into reimbursement and market access negotiations. Clinicians and payers will assess real‑world effectiveness and safety in broader MDD populations, and J&J will push for formulary placements to capture the anticipated growth.