FDA approves Spravato (esketamine) nasal spray for treatment-resistant depression
The FDA approved esketamine nasal spray, marketed as Spravato, for treatment-resistant depression in adults, to be used together with an oral antidepressant. Approval came with a Risk Evaluation and Mitigation Strategy (REMS) requiring administration in a certified healthcare setting with post-dose monitoring.
Record details
- Agency
- FDA
- Jurisdiction
- United States (federal)
- Status
- Final action
- Published
- March 5, 2019
- Effective
- March 5, 2019
- Expires
- Not applicable / not verified
- Last checked
- August 24, 2026
Why it matters
This is the only ketamine-related product with FDA approval for a depression indication. Racemic ketamine used in infusion clinics remains an off-label use of an anesthetic. The REMS requirement is also why esketamine cannot be taken home.
Primary source
FDA news release — FDA approves new nasal spray medication for treatment-resistant depression
Back to the Regulatory Tracker.
Founder and publisher of Ketalux, based in Chicago, Illinois. Ketalux.com is owned and operated by iDigits LLC. Ira commissions and edits the site's articles and believes ketamine therapy — used responsibly — offers real hope for people living with depression, anxiety, PTSD, and chronic pain. Contact: ira@idigits.com.
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.