J&J’s Spravato receives FDA label expansion for depression monotherapy
Johnson & Johnson’s (J&J) nasal spray Spravato (esketamine) has received a label expansion, now approved as a monotherapy treatment for major depressive disorder (MDD) in adults who do not respond to 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.
FDA Approves Johnson & Johnson’s Spravato for Treatment-Resistant Depression
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,
FDA approves Spravato, first monotherapy nasal spray to treat depression
The Food and Drug Administration has approved the first-ever stand-alone nasal spray to treat drug-resistant depression. Johnson & Johnson's Spravato was approved to treat a major depressive disorder,
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.
US FDA approves J&J's ketamine-based therapy to treat depression
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.
FDA approves Johnson & Johnson’s ketamine-derived nasal spray for depression as standalone treatment
The announcement was welcome news for those with major depressive disorder, affecting an estimated 8.3% of the adult population.
J&J's Depression Drug Spravato Gets FDA Nod for Monotherapy Use
Johnson & Johnson JNJ announced that the FDA has approved its supplemental new drug application (sNDA), seeking approval for Spravato (esketamine) as a monotherapy for adults living with treatment-resistant depression (TRD).
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.
J&J's ketamine-derived nasal spray approved by FDA to treat depression
Johnson & Johnson's ketamine-derived nasal spray has been approved as a standalone treatment to fight depression for those ...
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J&J's Spravato gets another lift with new FDA approval
The accelerating sales growth of Johnson & Johnson's Spravato could go up yet another gear after the FDA approved a third ...
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J&J’s ketamine-based drug approved as standalone treatment
"Treatment-resistant depression can be very complicated, especially for patients who do not respond to oral antidepressants ...
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J&J's Spra­va­to wins ex­pand­ed la­bel for de­pres­sion as sin­gu­lar treat­ment
J&J’s Spravato nasal spray received a label expansion on Tuesday, now approved as a standalone treatment for major depressive ...
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J&J Says Deals Likely to Shrink After $14.6B Intra-Cellular Buy
On the company’s Q4 earnings call where an eyepopping $88.8 billion in full-year sales were revealed, leaders shifted focus ...
J&J's Spravato Wins FDA Approval, Stands as a Game-Changer for Mental Health Care
Spravato was already available in the market before today's FDA approval and has already proven to be a financial success for ...