Spravato has been approved since 2019 for TRD, with its label extended the following year as a rescue therapy for adults with major depressive disorder (MDD) who were at risk of self-harm or suicide.

Credit: Johnson & Johnson. The approval of Spravato for the monotherapy indication in TRD was supported by data from the randomized, double-blind, placebo-controlled, phase 4 TRD4005 trial.

Spravato is classified as a Schedule III controlled substance and is only available through a restricted program called the Spravato REMS. The Food and Drug Administration (FDA) has approved ...

The U.S. Food and Drug Administration (FDA) approved the antidepressant nasal spray Spravato as a standalone treatment for depression in adults.

Johnson & Johnson's Spravato has been approved to treat a major depressive disorder in adults who have had an inadequate response to at least two oral antidepressants, the FDA announced Tuesday.

The Food and Drug Administration (FDA) has expanded its approval of a ketamine nasal spray, Spravato (esketamine), as a standalone therapy for adults with treatment-resistant depression.

21, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today the U.S. Food and Drug Administration (FDA) approval of a supplemental New Drug Application (sNDA) for SPRAVATO ...

This week, the US Food and Drug Administration expanded its approval of Spravato, an antidepressant nasal spray. The drug, made by Johnson & Johnson, is now cleared for use as the only standalone ...

This week, the Food and Drug Administration approved Johnson & Johnson’s ketamine-based nasal spray, Spravato, as a standalone therapy for cases of depression that haven’t responded to other ...

Now, the Food and Drug Administration (FDA) has expanded approval for Johnson & Johnson's nasal spray, Spravato, to be used as a standalone treatment for people with severe depression who haven't ...