💊FDA Withdraws Approval for ZULRESSO (Brexanolone) Solution
Sage Therapeutics, Inc.; Withdrawal of Approval of a New Drug Application for ZULRESSO (Brexanolone) Solution, 100 Milligrams/20 Milliliters
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Agency in writing that the drug product was no longer marketed and requested that the approval of the application be withdrawn.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The FDA's withdrawal of approval for ZULRESSO (brexanolone) has immediate implications for Sage Therapeutics, Inc. and the pharmaceutical market, affecting regulatory compliance and product inventory management. Businesses involved in drug distribution or marketing need to adjust their practices in accordance with the withdrawal notice.