FDA expands Spravato label to depressive symptoms in adults with acute suicidal ideation or behavior
The FDA approved a supplemental indication for Spravato covering depressive symptoms in adults with major depressive disorder who have acute suicidal ideation or behavior, used alongside an oral antidepressant. The approval did not establish that esketamine prevents suicide.
This page has been written and edited by the publisher. It has not been reviewed by a licensed clinician.
Record details
- Agency
- FDA
- Jurisdiction
- United States (federal)
- Status
- Final action
- Published
- August 3, 2020
- Effective
- August 3, 2020
- Expires
- Not applicable / not verified
- Last checked
- August 24, 2026
Why it matters
The indication addresses depressive symptoms in an acute-risk population, not suicide prevention itself — a distinction frequently blurred in marketing copy.
Primary source
FDA — Spravato prescribing information and approval history (Drugs@FDA)
Back to the Regulatory Tracker.
Publisher and editor of Ketalux, based in Chicago, Illinois. Ira is a ketamine therapy patient, not a clinician. This is editorial review, not medical review: Ira is not a licensed clinician and does not provide diagnosis or medical care. Ketalux does not accept compensation from providers in exchange for favorable editorial coverage, evidence ratings, recommendations, patient referrals, or organic provider ranking. Read the full publisher disclosure →
Educational use only. The content on this page is provided for general educational purposes and does not constitute medical advice, diagnosis, or treatment. Ketamine and related therapies carry risks and are appropriate only under qualified medical supervision. Always consult a licensed healthcare professional about your individual situation. Information may change as research evolves.