SPRAVATO - Johnson & Johnson
5 days ago · Titusville, New Jersey, January 21, 2025 – 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 ...
FDA approves standalone use of J&J’s ketamine-derived ... - CNN
5 days ago · 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 ...
FDA approves Johnson & Johnson nasal spray Spravato for …
5 days ago · Spravato is now the first-ever stand-alone therapy for treatment-resistant depression, and is on its way to becoming a blockbuster product.
Janssen Announces U.S. FDA Approval of SPRAVATO - Johnson & Johnson
Aug 3, 2020 · SPRAVATO ® is approved in the United States, in conjunction with an oral antidepressant, to treat adults with treatment-resistant depression (TRD) and depressive symptoms in adults with MDD with acute suicidal ideation or behavior.
SPRAVATO® (esketamine): A Prescription Nasal Spray | SPRAVATO…
You may report side effects to Johnson & Johnson at 1-800-526-7736, or to the FDA at 1-800-FDA-1088. Please see full Prescribing Information , including Boxed WARNINGS, and Medication Guide for SPRAVATO ® and discuss any questions you may have with your healthcare provider.
SPRAVATO® (esketamine) approved in the U.S. as the first and …
6 days ago · 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 ...
Johnson & Johnson seeks U.S. FDA approval of SPRAVATO® …
Johnson & Johnson seeks U.S. FDA approval of SPRAVATO® (esketamine) as the first and only monotherapy for adults with treatment-resistant depression
FDA Approves Johnson & Johnson’s Spravato for Treatment …
6 days ago · The FDA has approved Johnson & Johnson’s (J&J) Spravato (esketamine) 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 ...
FDA approves first-of-its-kind nasal spray for severe depression
5 days ago · At the end of week four of the trial, just 7.6-percent of the placebo group reported a MADRS score indicating remission, compared to 22.5-percent of those taking Spravato. According to Johnson ...
FDA allows standalone use of nasal spray antidepressant Spravato ...
5 days ago · The decision came after a large study found that Spravato alone worked better than a placebo. In the first nine months of 2024, the drug generated sales of about $780 million for its maker, Johnson & Johnson. Spravato is intended to be administered under the direct supervision of a healthcare provider.