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.