Sage Therapeutics, Inc.; Withdrawal of Approval of a New Drug Application for ZULRESSO (Brexanolone) Solution, 100 Milligrams/20 Milliliters

摘要

The Food and Drug Administration (FDA or Agency) is withdrawing approval of a new drug application (NDA) for ZULRESSO (brexanolone) solution, 100 milligrams (mg)/20 milliliters (mL), held by Sage Therapeutics, Inc., 55 Cambridge Parkway, Cambridge, MA 02142 (Sage). Sage notified the Agency in writing that the drug product was no longer marketed and requested that the approval of the application be withdrawn.