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

More from US FDA Performance Tracker

More from Regulatory Trackers