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...
Spravato Nasal Spray Can Now Be Used Alone for Treatment …
1 day ago · The Food and Drug Administration (FDA) has expanded its approval of a ketamine nasal spray, Spravato (esketamine), as a standalone therapy for adults with treatment …
SPRAVATO® (esketamine) approved in the U.S. as the first and …
Jan 21, 2025 · 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 …
Jan 22, 2025 · Spravato is the first and only approved monotherapy for adults with refractory major depressive disorder. Approval of Spravato, granted following FDA priority review, was …
FDA Approves Spravato Nasal Spray for Treatment-Resistant …
Jan 22, 2025 · 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 approves first-of-its-kind nasal spray for severe depression
Jan 22, 2025 · 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. …
What to Know About the New Nasal Spray for Tough Depression
1 day ago · The FDA’s latest approval of the nasal spray Spravato (esketamine) CIII allows people who have tried at least two oral antidepressants to use the spray on its own – without …
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 …
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 …
FDA allows standalone use of nasal spray antidepressant Spravato ...
Jan 21, 2025 · 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 …