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Orexo said it completed its FDA resubmission of the IZIPRY (naloxone nasal powder) NDA on Sept. 29, 2026, addressing deficiencies cited in a July 2024 complete response letter. FDA acceptance decision and an updated review timeline are expected in coming weeks.
Orexo AB OMXSTO:ORX
Orexo resubmitted its NDA for IZIPRY (naloxone nasal powder) to the FDA on Sep 29, 2026, addressing a 2024 CRL. FDA acceptance and a review timeline are expected in the coming weeks.Material DetailsContext by AI AnalystThis is a regulatory re-entry after a 2024 CRL, aligning with Orexo’s focus on o…