Posted by Michael Wonder on 28 Nov 2023
Orexo announces FDA acceptance of new drug application filing for OX124, a high-dose rescue medication for opioid overdose
28 November 2023 - PDUFA set to 15 July 2024. If approved, US launch is expected to be initiated late 2024.
Orexo today announces the new drug application for OX124 has been accepted for review by the US FDA.
