major depressive disorder, Spravato and FDA

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 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,
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 gets another lift with new FDA approval
The accelerating sales growth of Johnson & Johnson's Spravato could go up yet another gear after the FDA approved a third indication for the novel antidepressant.
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.
FDA allows standalone use of nasal spray antidepressant Spravato (esketamine)
The FDA says esketamine, an antidepressant derived from the anesthetic and party drug ketamine, can now be prescribed on its own. It was approved in 2019 to treat severe depression.
Johnson & Johnson's Spravato gains FDA nod to be used as a monotherapy
Already on its way to becoming a blockbuster drug, Johnson & Johnson’s Spravato has received another potential boost as the FDA has
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.
FDA Approves Nasal Spray for Depression
The U.S. Food and Drug Administration ( FDA) has approved the use of a nasal spray as a standalone treatment for major depressive disorder, offering a new option for those struggling with ...
Johnson & Johnson Tops Q4 EPS Forecasts
Johnson & Johnson surpassed earnings expectations with strong sales, but it faces challenges ahead due to patent expirations.
J&J's Spravato Wins FDA Approval, Stands as a Game-Changer for Mental Health Care
New Brunswick, NJ January 21, 2025 Johnson & Johnson ( NYSE:JNJ) has finally got its breakthrough depression treatment, ...
devdiscourse18h
Global Health Watch: Key Updates and Challenges
This summary covers the latest health-related news, including FDA's approval of Spravato as a standalone depression treatment ...