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,
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.
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,
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.
FDA approves first nasal spray treatment for severe depression
The FDA approved Johnson & Johnson’s Spravato nasal spray as a stand-alone treatment for patients suffering from severe depression. It is now the first-ever stand-alone therapy for treatment-resistant depression.
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.
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.
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.
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.
US FDA approves new nasal spray for depression treatment: All about it
The newly FDA-approved nasal spray called Spravato is being manufactured by Johnson & Johnson's and is a standalone treatment for major depressive disorder.
JNJ's SNDA For Spravato Monotherapy Gets FDA Approval For Treatment-Resistant Depression
Tuesday announced that the U.S. Food and Drug Administration has approved supplemental New Drug Application or sNDA for Spravato, a monotherapy for adults with treatment-resistant depression, a psychiatric disorder.
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, ...
Johnson & Johnson Tops Q4 EPS Forecasts
Johnson & Johnson surpassed earnings expectations with strong sales, but it faces challenges ahead due to patent expirations.