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
Further information
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