FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: SAGE THERAPEUTICS, INC.; WITHDRAWAL OF APPROVAL OF A NEW DRUG APPLICATION FOR ZULRESSO (BREXANOLONE) SOLUTION, 100 MILLIGRAMS/20 MILLILITERS

WASHINGTON, March 14 -- Food and Drug Administration has issued a notice called: Sage Therapeutics, Inc.; Withdrawal of Approval of a New Drug Application for ZULRESSO (Brexanolone) Solution, 100 Milligrams/20 Milliliters.

The notice was published in the Federal Register on March 14 by P. Ritu Nalubola, Associate Commissioner for Policy.

Summary: 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...