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OTC Naloxone May Get Another Push From US FDA As Agency Prepares Novel Switch Proposed Rule

Executive Summary

Financial model isn't adequate currently, FDA Commissioner Robert Califf says, and agency may make regulatory changes to motivate sponsors.

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US FDA Serves Notice: Approval Of OTC Naloxone Could Close Prescription Sales

Agency signals assurance about making naloxone available OTC, so much so that firms with approved NDAs for Rx products should prepare for an all-nonprescription market. After offering model label to spur OTC switch NDAs, FDA notice about OTC assessment is second unprecedented step on its naloxone journey since opioid crisis declared a public health emergency in 2017.

US FDA Serves Notice: Approval Of OTC Naloxone Could Close Prescription Sales

Agency signals assurance about making naloxone available OTC, so much so that firms with approved NDAs for Rx products should prepare for an all-nonprescription market. After offering model DFl to spur OTC switch NDAs, FDA notice about OTC assessment is second unprecedented step on its naloxone journey since opioid crisis declared a public health emergency in 2017.

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