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.
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)
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