Back to All Events

Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee

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.