US FDA Opens Door For J&J's Spravato To Another MDD Population

The US FDA approved the esketamine nasal spray for adults with major depressive disorder with suicidal ideation or behavior, following its initial approval in 2019 for treatment-resistant depression. 

depressed Women sitting head in hands on the bed in the dark bedroom with low light environment, dramatic concept
J&J's Spravato is approved for a new depression indication • Source: Shutterstock

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...

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