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Green Light For First OTC Naloxone In US After FDA Raises Caution Flag During Advisory Panel

Executive Summary

Sponsor Emergent revealed single-panel display of instructions at February advisory panel without testing in OTC human factors study. While different naloxone formulations and dosages will remain Rx-only, other Rx 4-mg nasal sprays, available through abbreviated NDAs as generics of Narcan, must transition to OTC, FDA says.

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Urgency For Approval Of OTC Naloxone In US Weighed Against Using Untested Package Labeling

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