FDA, Spravato and major depressive disorder

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 has been approved to treat a major depressive disorder in adults who have had an inadequate response to at least two oral antidepressants,
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 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.
J&J’s ketamine-derived nasal spray approved by FDA to treat depression
The Food and Drug Administration (FDA) approved Johnson & Johnson’s ketamine-derived nasal spray to help millions of U.S. patients suffering from severe depression.
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.
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
FDA Approves Johnson & Johnson’s Spravato for Treatment-Resistant Depression
CIII nasal spray, marking the first monotherapy to be approved for adults with treatment-resistant depression (TRD). According to the company, approval was supported by a pivotal placebo-controlled study in which Spravato demonstrated rapid and superior improvements in depressive symptoms as early as 24 hours,
SPRAVATO® (esketamine) approved in the U.S. as the first and only monotherapy for adults with treatment-resistant depression
Johnson & Johnson (NYSE: JNJ) announced today the U.S. Food and Drug Administration (FDA) approval of a supplemental New Drug Application (sNDA) for SPRAVATO® (esketamine) CIII nasal spray, making this innovative treatment the first and only monotherapy for adults living with major depressive disorder (MDD) who have had an inadequate response to at least two oral antidepressants.
FDA approves first nasal spray for major depression disorder
The U.S. Food and Drug Administration on Tuesday approved the first nasal spray that will help with treating 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.
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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J&J's Spra­va­to wins ex­pand­ed la­bel for de­pres­sion as sin­gu­lar treat­ment
J&J’s Spravato nasal spray received a label expansion on Tuesday, now approved as a standalone treatment for major depressive ...
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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 ...
J&J's Spravato Wins FDA Approval, Stands as a Game-Changer for Mental Health Care
Spravato was already available in the market before today's FDA approval and has already proven to be a financial success for ...