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.

Johnson & Johnson's ketamine-derived nasal spray has been approved as a standalone treatment to fight depression for those who had an inadequate response to oral antidepressants.

The FDA says esketamine, an antidepressant derived from the anesthetic and party drug ketamine, can now be prescribed on its own. It was approved in 2019 to treat severe depression.

Spravato is now the first-ever stand-alone therapy for treatment-resistant depression, and is on its way to becoming a blockbuster product.

Johnson & Johnson has announced that the U.S. Food and Drug Administration has approved Spravato (esketamine) CIII nasal spray as the first and only monoth

The U.S. Food and Drug Administration on Tuesday approved the first nasal spray that will help with treating major depressive disorder.

FDA approves Johnson & Johnson's Spravato nasal spray as a monotherapy for major depressive disorder, showing superior efficacy in clinical trials.

The approval of Spravato for the monotherapy indication in TRD was supported by data from the randomized, double-blind, placebo-controlled, phase 4 TRD4005 trial.

CIII nasal spray, marking the first monotherapy to be approved for adults with treatment-resistant depression (TRD). According to the company, approval was supported by a pivotal placebo-controlled study in which Spravato demonstrated rapid and superior improvements in depressive symptoms as early as 24 hours,

The U.S. Food and Drug Administration approved Johnson & Johnson's ketamine-based nasal spray Spravato to treat adults with major depressive disorder, the company said on Tuesday. The approval paves the way for use of Spravato in patients whose disease has stopped responding to at least two oral anti-depressants.