major depressive disorder, FDA and Spravato

FDA approves Spravato, first monotherapy nasal spray to treat depression
The Food and Drug Administration has approved the first-ever stand-alone nasal spray to treat drug-resistant depression. Johnson & Johnson's Spravato was approved to treat a major depressive disorder,
FDA approves first standalone nasal spray for severe depression
Johnson & Johnson has announced the FDA’s approval of a first-of-its-kind, esketamine nasal spray called Spravato for the standalone treatment of major depressive disorder (MDD), PTSD, and similar psychiatric conditions.
FDA Clears Spravato For Monotherapy Depression Treatments
The Food and Drug Administration has approved Johnson & Johnson's nasal spray as a standalone treatment for severe forms of depression, officials said. The FDA granted approval to Spravato (esketamine) as the first monotherapy for adults with treatment-resistant depression,
FDA approves Spravato as monotherapy for adults with major depressive disorder
The FDA has approved a supplemental new drug application for Spravato, an esketamine nasal spray that can be used as monotherapy for adults with treatment-resistant depression, Johnson & Johnson announced in a press release.
J&J approves 1st monotherapy for treatment-resistant depression
Johnson & Johnson has received FDA approval for Spravato nasal spray as the first and only monotherapy for adults with treatment-resistant depression.
J&J’s Spravato Makes Headway in Tough Depression Space With Monotherapy Approval
Esketamine, the active ingredient in Spravato, is a non-selective, non-competitive antagonist of the NMDA receptor, a known target in depression. Since its initial approval in 2019, Spravato has become one of J&J’s high-growth brands, surging around 55% year-over-year in the third quarter of 2024 to bring in $284 million worldwide.
A Nasal Spray For Depression? FDA Gives Its Approval
The U.S. Food and Drug Administration (FDA) has approved Johnson & Johnson's nasal spray, Spravato (esketamine), as the first standalone therapy for adults suffering from major depressive disorder (MDD) who have not responded adequately to at least two oral antidepressants.
J&J’s Spravato receives FDA label expansion for depression monotherapy
Johnson & Johnson’s (J&J) nasal spray Spravato (esketamine) has received a label expansion, now approved as a monotherapy treatment for major depressive disorder (MDD) in adults who do not respond to two oral antidepressants.
Spravato Approved as Monotherapy for Treatment-Resistant Depression
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.
FDA approves standalone use of J&J’s ketamine-derived depression treatment
The U.S. Food and Drug Administration expanded approval for Johnson & Johnson’s nasal spray, Spravato, to allow it to be used as a standalone treatment for patients with severe depression, the company said on Tuesday.
Johnson & Johnson Gets FDA OK For Spravato as Monotherapy
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.
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