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Esketamine is the second drug to be approved for TRD 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 MDD in people with a partial response to treatment. [25]
The PDUFA date thus serves as a 'best estimate' of when a decision on a New Drug Application or a Biologics License Application would be forthcoming. This response may be a decision to approve the application or a Complete Response Letter (CRL). The PDUFA date may be extended by the Food and Drug Administration in certain circumstances. [6]
Although the FDA has approved ketamine for use as an anesthetic, infusion therapy hasn't been approved to treat chronic pain, depression, or other conditions. Skip to main content. Subscriptions ...
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 ...
GoodRx released a list of 19 of the most influential drugs and vaccines approved by the FDA in 2024 to treat a variety of conditions. These medications are “slated to make a big clinical impact."
Lykos Therapeutics is cutting 75% of staff after FDA rejected its MDMA drug for mental health. The FDA's decision marks the first time the agency considered a psychedelic for medical use.
The US Food and Drug Administration (FDA) first approved the use of intranasal esketamine —an enantiomer of ketamine—for the use of ketamine-derived therapy for treatment-resistant depression, in 2019, [11] leading to the creation and expansion of telemedicine-based companies that practice KAP, such as Mindbloom. [12]
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