Naloxone OTC Switch NDA Has US FDA Concerned Labeling Will Cause User Error, Delay Delivery
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.”
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“Meeting is no longer needed,” agency states in announcement. The same committees’ unanimous recommendation during a meeting in February on Emergent’s sNDA for OTC sales of 4-mg naloxone nasal spray made a repeat for HRT’s NDA for 3-mg spray unnecessary.
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.
Larger box “would accommodate all five steps on the single back panel,” says Emergent executive Manish Vyas. But FDA says proposed DFl for OTC Narcan nasal spray “has not yet been officially submitted or reviewed.”