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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,
J&J’s Spravato receives FDA label expansion for depression monotherapy
The FDA’s decision marks J&J's Spravato as the first monotherapy for adults with treatment-resistant depression.
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 Nasal Spray as a Standalone Treatment for Major Depressive Disorder
One-third of folks with major depressive disorder experience treatment-resistant depression (TRD), a condition that makes it more difficult to be treated by traditional 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 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 treatment-resistant 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
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 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.
pharmaphorum
1h
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 ...
WUWM
8h
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 ...
19h
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 ...
devdiscourse
14h
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 ...
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Johnson & Johnson
United States
Ketamine
Food and Drug Administration
depression
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