The committees met jointly to discuss the efficacy, safety, and benefit-risk profile of a new drug application for Zulresso (brexanolone) 5 mg/mL intravenous injection, submitted by Sage Therapeutics (Sage), for the proposed indication of postpartum depression (PPD). The joint committee voted nearly unanimously (17 of 18 membersr) in favor of recommending approval.
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Earlier Event: November 1Advisory Committee on Heritable Disorders in Newborns and Children
Later Event: November 8Vaccines and Related Biological Products Advisory Committee