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The Food and Drug Administration (FDA) recently approved the nasal spray Spravato for the treatment of major depression in people who have not responded to at least two oral antidepressants.
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 ...
However, they may cover the FDA-approved nasal spray, Spravato, which contains a derivative of ketamine called esketamine. This article examines Medicare coverage for ketamine infusion, coverage ...
Esketamine is the second drug to be approved for treatment-resistant depression by the FDA, following olanzapine/fluoxetine (Symbyax) in 2009. [ 25 ] [ 50 ] Other agents, like the atypical antipsychotics aripiprazole (Abilify) and quetiapine (Seroquel), have been approved for use in the adjunctive therapy of major depressive disorder in people ...
An enantiomer of ketamine – esketamine commercially sold as Spravato – was approved as an antidepressant by the European Medicines Agency in 2019. [63] Esketamine was approved as a nasal spray for treatment-resistant depression in the United States [64] and elsewhere in 2019 (see Esketamine and Depression). The Canadian Network for Mood and ...
The drug is a novel esketamine analogue and conjugate that acts as a prodrug of esketamine. [3] Esketamine, and by extension XW10508, is an NMDA receptor antagonist and indirect AMPA receptor activator. [1] [5] XW10508 is being developed as once-daily orally administered extended-release and immediate-release formulations with misuse resistance ...
The U.S. Food and Drug Administration has approved a nose spray to help treat depression, Johnson & Johnson announced Tuesday. ... The main ingredient for the spray is esketamine hydrochloride, ...
The U.S. Kefauver–Harris Amendment or "Drug Efficacy Amendment" is a 1962 amendment to the Federal Food, Drug, and Cosmetic Act. It introduced a requirement for drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval, [1] [2] required drug advertising to disclose accurate information about side effects, and stopped cheap generic drugs being marketed ...