SPRAVATO® (esketamine) approved in the U.S. as the first and …
5 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 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 Spravato Nasal Spray for Treatment-Resistant …
4 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 Spravato Nasal Spray for Treatment-Resistant …
5 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 …
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 approves first-of-its-kind nasal spray for severe depression
5 days ago · The FDA fast-tracked Spravato’s approval through its Priority Review process after receiving results from a randomized, double-blind, placebo-controlled study of the medication. …
FDA Expands Approval of Intranasal Esketamine Therapy (Spravato)
5 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 …
FDA warns about compounded ketamine for psychiatric disorders
Oct 10, 2023 · Spravato (which includes only the esketamine molecule), is approved as a nasal spray for treatment-resistant depression in adults and for depressive symptoms in adults with …
FDA approves Johnson & Johnson nasal spray Spravato for …
5 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.
FDA allows standalone use of nasal spray antidepressant Spravato ...
5 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 …