Posted by Michael Wonder on 23 Aug 2021
Axsome Therapeutics provides update on the new drug application for AXS-05 for the treatment of major depressive disorder
23 August 2021 - Axsome Therapeutics today announced that the U.S. FDA informed the Company in a teleconference on August 20, 2021, that its review of the new drug application for AXS-05 for the treatment of major depressive disorder would not be completed by the Prescription Drug User Fee Act target action date of 22 August 2021.
The FDA did not request additional information from the Company, and the review of the application is on-going.
