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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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Emergent’s OTC Naloxone Single-Panel Instruction List Prompts Doubletake From US FDA Officials

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

All members of joint advisory panel noted urgent need to expand access to naloxone and voted yes on OTC sales of Emergent's Narcan nasal spray, but many also pointed out concerns for testing needed for DFl Facts label firm unveiled to the panel as well as to FDA officials during  meeting.

Rx Naloxone Marketer's OTC Switch Proposal For Nasal Spray Gets Priority Review From FDA

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