On Emergent OTC Naloxone Switch, Tight Timeline For FDA Decision Following Advisory Committee

NDAC, AADPAC Meeting 15 February, PDUFDA Date 29 March For Emergent’s Proposal

Priority review pushes up to 29 March FDA’s deadline for decision on Emergent’s sNDA for OTC Narcan nasal spray. Agency schedules joint advisory committee on proposal for 15 February.

A joint advisory committee will discuss OTC sales of naloxone nasal spray six weeks before US regulators are due to decide whether to approve the first proposal they received after encouraging drug firms to expand naloxone access and help curb the nationwide opioid overdose crisis.

And after considering Emergent BioSolutions Inc.’s proposal in a meeting conducted online on 15 February, the Food and Drug Administration...