1. Pink Sheet

OTC Naloxone May Get Another Push From US FDA As Agency Prepares Novel Switch Proposed Rule

 
• By Derrick Gingery

Financial model is not adequate right now, FDA Commissioner Robert Califf says, so the agency may make regulatory changes to motivate sponsors.

Narcan device
FDA Commissioner Robert Califf said the instructions for use will be important for OTC naloxone products. • Source: Shutterstock

Naloxone manufacturers could receive another regulatory nudge from the US Food and Drug Administration to produce an OTC nasal spray of the opioid overdose medication.

Commissioner Robert Califf said the agency is having “serious discussions right now about what we can do to exert some changes compared to the

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