The expanded indication allows esketamine nasal spray to be used as a standalone treatment in adults with MDD who have not responded to at least two oral antidepressants.

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.

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.

Johnson & Johnson (NYSE:JNJ) reported a fourth-quarter adjusted EPS of $2.04, down 10.9% year over year, beating the consensus of $2.01. The pharmaceutical giant reported sales of $22.52 billion, up 5.

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

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.

The U.S. Food and Drug Administration has approved a nose spray to help treat depression, Johnson & Johnson announced Tuesday.

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.