Major Depressive Disorder with Acute Suicidal Ideation or Behavior
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FDA approval · 2025-04-28FDA Approved: SPRAVATO — Supplemental Application (Janssen Pharmaceuticals Inc.)
FDA approves a supplemental application for SPRAVATO (esketamine hydrochloride) submitted by Janssen Pharmaceuticals Inc.
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FDA approval · 2019-06-25FDA Approved: SPRAVATO — Supplemental Application (Janssen Pharmaceuticals Inc.)
FDA approved Janssen's supplemental application for SPRAVATO (esketamine hydrochloride), resulting in labeling changes for the product.