Posted by Michael Wonder on 26 Apr 2021
Axsome Therapeutics announces FDA acceptance and priority review of new drug application for AXS-05 for treatment of major depressive disorder
26 April 2021 - FDA grants priority review and sets PDUFA action goal date of 22 August 2021.
Axsome Therapeutics today announced that the U.S. FDA has accepted for filing the Company’s New Drug Application for AXS-05 for the treatment of major depressive disorder and has granted the application priority review.
AXS-05 (dextromethorphan-bupropion) is a novel, oral, investigational NMDA receptor antagonist with multimodal activity.
