A US FDA advisory committee backed the approval of Janssen R&D LLC’s depression drug esketamine but said the parameters of a proposed Risk Evaluation and Mitigation Strategy (REMS) need to be better defined, particularly as to the types of facilities where the drug will be administered.
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.
