NetworkNewsBreaks – Nutriband Inc. (NASDAQ: NTRB
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Posted On: 10/28/2025 5:08:50 PM
NetworkNewsBreaks – Nutriband Inc. (NASDAQ: NTRB) Receives FDA Meeting Feedback Advancing AVERSA(TM) Fentanyl Toward 505(b)(2) NDA Submission
Nutriband (NASDAQ: NTRB), a developer of prescription transdermal pharmaceutical products, today announced it has received final meeting minutes from its Sept. 18, 2025, virtual meeting with the U.S. Food and Drug Administration (FDA) regarding its lead product, AVERSA(TM) FENTANYL, an abuse-deterrent fentanyl transdermal system. The meeting with the Division of Anesthesiology, Addiction Medicine, and Pain Medicine confirmed the regulatory pathway as a 505(b)(2) New Drug Application and provided guidance on the reference listed drug and bridging strategy. The FDA also offered feedback on manufacturing validation, product specifications, and stability testing, along with expectations for in vitro manipulation and extraction studies to characterize AVERSA’s abuse-deterrent properties for potential NDA submission.
NOTE TO INVESTORS: The latest news and updates relating to NTRB are available in the company’s newsroom at https://nnw.fm/NTRB
Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or republished: http://NNW.fm/Disclaimer
Nutriband (NASDAQ: NTRB), a developer of prescription transdermal pharmaceutical products, today announced it has received final meeting minutes from its Sept. 18, 2025, virtual meeting with the U.S. Food and Drug Administration (FDA) regarding its lead product, AVERSA(TM) FENTANYL, an abuse-deterrent fentanyl transdermal system. The meeting with the Division of Anesthesiology, Addiction Medicine, and Pain Medicine confirmed the regulatory pathway as a 505(b)(2) New Drug Application and provided guidance on the reference listed drug and bridging strategy. The FDA also offered feedback on manufacturing validation, product specifications, and stability testing, along with expectations for in vitro manipulation and extraction studies to characterize AVERSA’s abuse-deterrent properties for potential NDA submission.
NOTE TO INVESTORS: The latest news and updates relating to NTRB are available in the company’s newsroom at https://nnw.fm/NTRB
Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or republished: http://NNW.fm/Disclaimer
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