SPRAVATO® (esketamine) approved in the U.S. as the first and …
6 days ago · Following U.S. FDA Priority Review, approval is based on data demonstrating SPRAVATO® alone met its primary endpoint at 4 weeks and led to rapid and superior …
FDA Approves Spravato Nasal Spray for Treatment-Resistant …
5 days ago · Spravato is the first and only approved monotherapy for adults with refractory major depressive disorder. Approval of Spravato, granted following FDA priority review, was based …
FDA approves new nasal spray medication for treatment-resistant ...
The U.S. Food and Drug Administration today approved Spravato (esketamine) nasal spray, in conjunction with an oral antidepressant, for the treatment of depression in adults who have...
FDA approves Johnson & Johnson nasal spray Spravato for …
6 days ago · Spravato is now the first-ever stand-alone therapy for treatment-resistant depression, and is on its way to becoming a blockbuster product.
SPRAVATO™ is a non-competitive N-methyl D-aspartate (NMDA) receptor antagonist indicated, in conjunction with an oral antidepressant, for the treatment of treatment-resistant...
FDA allows standalone use of nasal spray antidepressant Spravato ...
6 days ago · The FDA says esketamine, an antidepressant derived from the anesthetic and party drug ketamine, can now be prescribed on its own. ... Spravato is intended to be administered …
FDA Approves Spravato Nasal Spray for Treatment-Resistant …
6 days ago · Approval of Spravato, granted following FDA priority review, was based on the results of a randomized, double-blind, multicenter, placebo-controlled trial. On day 28 of the …
FDA Expands Approval of Intranasal Esketamine Therapy (Spravato)
6 days ago · The FDA’s decision to approve Spravato for standalone use represents a beacon of hope for these individuals, offering a faster-acting, innovative treatment option. As the …
Consider the risks and benefits of prescribing SPRAVATO prior to using in patients at higher risk of abuse. Monitor patients for signs and symptoms of abuse and misuse. Increased risk of …
Janssen Announces U.S. FDA Approval of SPRAVATO
Aug 3, 2020 · SPRAVATO ® is approved in the United States, in conjunction with an oral antidepressant, to treat adults with treatment-resistant depression (TRD) and depressive …
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