FDA approves Spravato as a standalone (monotherapy) treatment for treatment-resistant depression
The FDA approved esketamine nasal spray for use without a concurrent oral antidepressant in adults with treatment-resistant depression. REMS certification and in-clinic monitoring requirements continue to apply.
Record details
- Agency
- FDA
- Jurisdiction
- United States (federal)
- Status
- Final action
- Published
- January 21, 2025
- Effective
- January 21, 2025
- Expires
- Not applicable / not verified
- Last checked
- August 24, 2026
Why it matters
Patients who cannot tolerate oral antidepressants gained a labeled pathway. Monitoring, certification, and setting requirements did not change.
Primary source
FDA — Spravato approval history and labeling (Drugs@FDA)
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