Emergent’s OTC Naloxone Single-Panel Instruction List Prompts Doubletake From US FDA Officials
Executive Summary
Larger box “would accommodate all five steps on the single back panel,” says Emergent executive Manish Vyas. But FDA says proposed DFl for OTC Narcan nasal spray “has not yet been officially submitted or reviewed.”
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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, generics of the Narcan 4-mg nasal spray must transition to OTC, FDA says.
Green Light For First OTC Naloxone In US After FDA Raises Caution Flag During Advisory Panel
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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