Johnson & Johnson's Spravato (esketamine) has gotten off to a slow start commercially, but the company now has a new indication to promote for the antidepressant. The US Food and Drug Administration has cleared Spravato for use in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior.
The supplemental new drug application approval, granted late on 31 July, comes more than one year after the FDA approved Spravato in March 2019 for treatment-resistant depression, defined as when a patient with MDD fails to respond to at least two different antidepressants