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

 
• By Malcolm Spicer

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.

• Source: Shutterstock

A surprise sprung at an advisory panel meeting in February by the sponsor of an application for the first US OTC naloxone product didn’t knock the Food and Drug Administration off track as the agency met its deadline for a decision on the proposal.

The FDA and the proposal’s sponsor, Emergent BioSolutions, Inc., on 29 March separately announced the agency’s approval of the...

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