Pharm Exec · 13h
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,
YAHOO!Finance · 17h
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.
Managed Healthcare Executive · 1h
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.
Business Insider · 15h
JNJ's SNDA For Spravato Monotherapy Gets FDA Approval For Treatment-Resistant Depression
(RTTNews) - Johnson & Johnson (JNJ), 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.
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