Business · 14/03/2025Updated: 10/17/2026 · 1 min read
FDA Withdraws Approval of Brexanolone Drug Application by Sage Therapeutics
Summary
The FDA is withdrawing approval of a new drug application for ZULRESSO (brexanolone) solution, 100 milligrams/20 milliliters, held by Sage Therapeutics, following the company's request to discontinue marketing the product.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →