Spravato FDA Approval History
Last updated by Judith Stewart, BPharm on April 5, 2023.
FDA Approved: Yes (First approved March 5, 2019)
Brand name: Spravato
Generic name: esketamine
Dosage form: Nasal Spray
Company: Janssen Pharmaceuticals, Inc.
Treatment for: Depression, Major Depressive Disorder with Acute Suicidal Ideation
Spravato (esketamine) is a rapid acting, nasal spray formulation of a non-competitive N-methyl D-aspartate (NMDA) receptor antagonist for the treatment of treatment-resistant depression (TRD) and depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior.
- Spravato is indicated in conjunction with an oral antidepressant for the treatment of treatment-resistant depression (TRD) in adults and depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior.
- Because of the risks for sedation, dissociation, and abuse and misuse, Spravato is only available through a restricted program called the Spravato Risk Evaluation and Mitigation Strategy (REMS) Program.
- Spravato nasal spray is self-administered by patients under the supervision of a healthcare professional in a certified healthcare setting. Patients must be monitored for at least two hours after receiving a dose. The nasal spray cannot be taken home.
- Spravato contains esketamine, which is the s-enantiomer of ketamine. The FDA first approved ketamine (Ketalar) in 1970. Spravato is the first FDA approval of esketamine for any use.
Development timeline for Spravato
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.