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Orexo resubmits IZIPRY NDA to FDA for opioid overdose treatment

Orexo resubmits IZIPRY NDA to FDA for opioid overdose treatment

BitgetBitget2026/09/29 13:45
  • Orexo completed its FDA resubmission of the IZIPRY (naloxone nasal powder) NDA on Sept. 29, 2026.
  • Filing aims to address deficiencies cited in the FDA’s July 2024 complete response letter.
  • FDA acceptance decision and an updated review timeline are expected in the coming weeks.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Orexo AB published the original content used to generate this news brief on September 29, 2026, and is solely responsible for the information contained therein.

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