Johnson & Johnson seeks US FDA approval of Spravato (esketamine) as the first and only monotherapy for adults with treatment-resistant depression

Johnson & Johnson

22 July 2024 - Phase 4 Spravato monotherapy data shows rapid improvement in depressive symptoms at ~24 hours, sustained through at least 4 weeks.

Johnson & Johnson announced today the submission of a supplemental new drug application to the US FDA seeking approval of Spravato (esketamine) nasal spray as a monotherapy for adults living with treatment-resistant depression.

Read Johnson & Johnson press release

Michael Wonder

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Michael Wonder

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Medicine , US , Dossier