Emergent’s OTC Naloxone Single-Panel Instruction List Prompts Doubletake From US FDA Officials

Emergent BioSolutions, Inc. acted fast, like the opioid overdose treatment it’s proposed for OTC sales, preparing labeling with instructions on a single page after the US Food and Drug Administration indicated it doubted spreading the information over multiple panels would be effective.

“What we're now proposing is a larger box, which would accommodate all five steps on the single back panel,” said Manish Vyas, Emergent’s regulatory affairs senior vice president, on 15 February during a joint meeting of the FDA’s