Sage Gets More Time For Zulresso Launch Preparations With Delay Of US FDA Approval

After an advisory committee recommended approval for the postpartum depression treatment if administered under a REMS program at certified centers, Sage submitted a proposed REMS, causing the agency to extend the PDUFA date three months.

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SAGE Therapeutics Inc. will get at least three more months to prepare for the US launch of Zulresso (brexanolone) now that the US FDA has extended the user fee date for its new drug application after the company submitted a proposed risk evaluation and mitigation strategy (REMs) program for the intravenously administered postpartum depression (PPD) drug.

Cambridge, Mass.-based Sage said on Nov. 20 that it now expects to have an FDA approval decision by March 19...