1. Pink Sheet

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

 
• By Malcolm Spicer

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

The joint advisory committee voted unanimously that the benefit-risk calculation supported nonprescription use. • Source: Shutterstock

The US Food and Drug Administration has six weeks to decide whether to follow an advisory committee's unanimous recommendation to approve the first OTC switch proposal for a naloxone product or to ask the sponsor to test labeling first revealed during the meeting.

The agency will weigh approving Emergent BioSolutions, Inc.’s supplemental new drug application for OTC sale of its Narcan (naloxone/4 mg) nasal spray without data from label comprehension or human...

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