The FDA’s decision marks J&J's Spravato as the first monotherapy for adults with treatment-resistant depression.
Spravato is classified as a Schedule III controlled substance and is only available through a restricted program called the Spravato REMS. The Food and Drug Administration (FDA) has approved ...
Now, the Food and Drug Administration (FDA) has expanded approval for Johnson & Johnson's nasal spray, Spravato, to be used as a standalone treatment for people with severe depression who haven't ...
Already on its way to becoming a blockbuster drug, Johnson & Johnson’s Spravato has received another potential boost as the FDA has blessed the nasal spray to be used as a monotherapy for major ...
Credit: Johnson & Johnson. 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.
Spravato, okayed for stand-alone use among adults, is the first such therapy for major depressive disorder (MDD) that is difficult to treat. The United States Food and Drug Administration (FDA ...
Drug is the first and only approved monotherapy for refractory major depressive disorder. (HealthDay News) — The US Food and Drug Administration has approved Spravato (esketamine) CIII nasal ...
Please provide your email address to receive an email when new articles are posted on . Spravato is the first monotherapy for adults with major depressive disorder who had an inadequate response ...
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, the FDA announced Tuesday.
Johnson & Johnson JNJ announced that the FDA has approved its supplemental new drug application (sNDA), seeking approval for Spravato (esketamine) as a monotherapy for adults living with treatment ...
Parkside Psychiatric Hospital in Tulsa has an on-site Spravato outpatient clinic that sees over 20 patients per week. According to Parkside, these patients are seen at least twice a week for the ...
"SPRAVATO ® is now available as a standalone treatment, meaning patients may experience improvements in depressive symptoms as early as 24 hours and at 28 days – without the need for daily oral ...