FDA, major depressive disorder and Esketamine

FDA approves first-of-its-kind nasal spray for severe depression
Johnson & Johnson has announced the FDA’s approval of a first-of-its-kind, esketamine nasal spray called Spravato for the standalone treatment of major depressive disorder (MDD), PTSD, and similar psychiatric conditions.
FDA Expands Approval of Esketamine for Depression
The FDA approved esketamine (Spravato) nasal spray as monotherapy for adults with treatment-resistant depression who had an inadequate response to at least two oral antidepressants, maker Johnson & Johnson announced on Tuesday.
Esketamine Approved by FDA as First Monotherapy for Treatment-Resistent Depression
Esketamine (Spravato; Johnson & Johnson) is now the first and only monotherapy for adults with major depressive disorder (MDD) with inadequate response to at least 2 oral antidepressants.
FDA approves nasal spray for treatment-resistant depression
CIII nasal spray for adults living with major depressive disorder who have had an inadequate response to at least two oral antidepressants, according to a news release issued by Johnson & Johnson.
FDA approves Spravato as monotherapy for adults with major depressive disorder
The FDA has approved a supplemental new drug application for Spravato, an esketamine nasal spray that can be used as monotherapy for adults with treatment-resistant depression, Johnson & Johnson announced in a press release.
FDA approves Spravato as first stand-along nasal spray to treat drug-resistant depression
In today's Health Alert, the FDA has approved the first stand-alone nasal spray to treat drug-resistant depression.
A Nasal Spray For Depression? FDA Gives Its Approval
The U.S. Food and Drug Administration (FDA) has approved Johnson & Johnson's nasal spray, Spravato (esketamine), as the first standalone therapy for adults suffering from major depressive disorder (MDD) who have not responded adequately to at least two oral antidepressants.
J&J’s Spravato Makes Headway in Tough Depression Space With Monotherapy Approval
Esketamine, the active ingredient in Spravato, is a non-selective, non-competitive antagonist of the NMDA receptor, a known target in depression. Since its initial approval in 2019, Spravato has become one of J&J’s high-growth brands, surging around 55% year-over-year in the third quarter of 2024 to bring in $284 million worldwide.
SPRAVATO® (esketamine) approved in the U.S. as the first and only monotherapy for adults with treatment-resistant depression
Johnson & Johnson (NYSE: JNJ) announced today the U.S. Food and Drug Administration (FDA) approval of a supplemental New Drug Application (sNDA) for SPRAVATO® (esketamine) CIII nasal spray, making this innovative treatment the first and only monotherapy for adults living with major depressive disorder (MDD) who have had an inadequate response to at least two oral antidepressants.
FDA Approves Esketamine Nasal Spray for Treatment-Resistant Depression
The FDA has approved esketamine (Spravato) nasal spray as a monotherapy for adults with treatment-resistant depression. This approval applies to individuals who have had an inadequate response
FDA approves standalone use of J&J’s ketamine-derived depression treatment
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 with severe depression, the company said on Tuesday.
TTUHSC Psychiatry chairman discusses newly approved antidepressant nasal spray
The FDA approved Spravato for those battling depression and has seen little to no improvement from two types of ...
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FDA allows standalone use of nasal spray antidepressant Spravato (esketamine)
The FDA says esketamine, an antidepressant derived from the anesthetic and party drug ketamine, can now be prescribed on its ...