Orexo announces FDA acceptance of New Drug Application filing for OX124, a high-dose rescue medication for opioid overdose
UPPSALA, Sweden, Nov. 28, 2023 /PRNewswire/ — Orexo AB (publ.), (STO: ORX) (OTCQX: ORXOY), today announces the New Drug Application (NDA) for OX124 has been accepted for review by the US Food and Drug Administration (FDA). OX124 is a nasal rescue medication for opioid overdose containing a high dose of naloxone and is the first product based on Orexo´s world-class drug delivery platform, amorphOX®. The PDUFA date is set to July 15, 2024, but recent review processes in the category indicate a risk of some delay.
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