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

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

The US Food and Drug Administration has six weeks to decide whether to follow an advisory panel’s unanimous recommendation to approve the first OTC switch proposal for a naloxone product or to ask the sponsor to test labeling it didn’t reveal until the panel’s meeting.

The agency will weigh approving Emergent BioSolutions, Inc.’s supplemental new drug application for OTC sales of its Narcan (naloxone/4...