Janssen’s Esketamine Needs Better Defined REMS, US FDA Panel Says
Advisory committee overwhelmingly endorses approval for patients with treatment-resistant depression but says proposed Risk Evaluation and Mitigation Strategy needs refinement, including clarifying the types of facilities where the drug will be administered.
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Janssen’s Spravato Enters US Market With Enhanced REMS And Plans For A Monotherapy Trial
Restrictive risk management plan for antidepressant nasal spray requires patients be monitored for two hours after dosing and enroll in a patient registry; Janssen has agreed to conduct a monotherapy efficacy trial as a postmarketing commitment.