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Naloxone OTC Switch NDA Has US FDA Concerned Labeling Will Cause User Error, Delay Delivery

 
• By Malcolm Spicer

CDER will ask advisory panel “whether additional labeling information might mitigate risk of use errors” for Emergent’s naloxone nasal spray made available OTC and whether results of firm’s human factors study “support that consumers are able to correctly administer nonprescription [naloxone nasal spray] in an emergency situation.”

• Source: Shutterstock

A proposal in the US to make a naloxone nasal spray available nonprescription is unlike any previous Rx-to-OTC switch application the Food and Drug Administration has considered because it’s for a drug needed to help stem an ongoing nationwide epidemic.

Like all switch applications, though, the agency’s decision depend on whether labeling included in the proposal effectively guides consumers to...

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Over The Counter: Taking Real-World Evidence Seriously, With IQVIA Consumer Health’s Volker Spitzer

 
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