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 …
Spravato Nasal Spray Can Now Be Used Alone for Treatment …
Jan 28, 2025 · The Food and Drug Administration (FDA) has expanded its approval of a ketamine-derived nasal spray, Spravato (esketamine), as a standalone therapy for adults with …
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™ 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 standalone use of J&J’s ketamine-derived ... - CNN
Jan 22, 2025 · The U.S. Food and Drug Administration expanded approval for Johnson & Johnson’s nasal spray, Spravato, to allow it to be used as a standalone treatment for patients …
FDA approves Johnson & Johnson nasal spray Spravato for …
Jan 21, 2025 · Spravato is now the first-ever stand-alone therapy for treatment-resistant depression, and is on its way to becoming a blockbuster product.
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 …
Please refer to your supplemental new drug application (NDA) submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Spravato (esketamine) nasal spray.
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 …
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 …