FDA Accepts Resubmission of New Drug Application for IZIPRY™, a High-Dose Naloxone Nasal Powder for Opioid Overdose

Orexo AB announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmitted New Drug Application (NDA) for IZIPRY™ (naloxone nasal powder). IZIPRY™ is a high-dose naloxone rescue medication designed to reverse overdoses involving potent synthetic opioids like fentanyl. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of March 29, 2027.