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.

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.

MDD affects an estimated 21 million adults in the U.S., and about one-third of these patients do not respond to oral antidepressants alone. The approval of SPRAVATO® as a monotherapy provides a ...

The FDA has approved Janssen’s antidepressant nasal spray Spravato, making it the first new type of depression treatment to hit the market in 30 years – although its use will be restricted to ...

Johnson & Johnson has won Food and Drug Administration expanded approval of its Spravato nasal spray as a lone therapy for adults with treatment-resistant depression. J&J on Tuesday said the green ...