Rx Naloxone Marketer's OTC Switch Proposal For Nasal Spray Gets Priority Review From FDA

 
• By Malcolm Spicer

Emergent BioSolutions’ announcement of FDA accepting sNDA for an OTC 4-mg naloxone nasal spray marks another recent step in agency’s response under Commissioner Califf to Capitol Hill pressure to expand availability of topioid antagonist to help curb opioid overdose death epidemic.

With priority review granted for Emergent's sNDA for OTC Narcan nasal spay. FDA’s deadline under PDUFA for a decision is 29 March. • Source: Shutterstock

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