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 light makes Spravato the first and only monotherapy for adults with major depressive disorder who have had an inadequate response to at least two oral antidepressants.
The FDA in 2019 approved Spravato, a close chemical relation to ketamine, in combination with an oral antidepressant for adults with treatment-resistant depression.
Spravato generated sales of $780 million for the first nine months of 2024, up more than 60% from a year earlier.
New Brunswick, N.J., healthcare giant said Spravato has been administered to more than 140,000 patients worldwide.
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