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.

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.

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,

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.

An emerging treatment for clinical depression has reached an important milestone. This week, the Food and Drug Administration approved Johnson & Johnson’s ketamine-based nasal spray, Spravato, as a standalone therapy for cases of depression that haven’t responded to other options.

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.

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

On Tuesday, the FDA approved Johnson & Johnson’s (NYSE:JNJ) supplemental New Drug Application for Spravato (esketamine) CIII nasal spray. The approval makes the 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.

On Tuesday, the US Food and Drug Administration (FDA) approved Johnson & Johnson's hallucinogenic drug esketamine (brand name Spravato) nasal spray as a "monotherapy" treatment for major depressive disorder.

The Sackler family, owners of Purdue Pharma, reached a $7.4 billion settlement to resolve mass opioid litigation. The Department of Justice filed a civil lawsuit against Walgreens over allegations it violated the Controlled Substances Act and the False Claims Act.

A nasal spray therapy for treatment-resistant major depressive disorder (MDD) has now been approved by the Food and Drug Administration (FDA) for use on its own, making it the first-ever approved standalone treatment for this condition.