FDA Releases Model Drug Facts Labeling For Over-The-Counter Naloxone

On January 17, 2019, the U.S. Food and Drug Administration (FDA) released model drug facts labeling (DFL) to support the development of over-the-counter (OTC) versions of naloxone to reverse opioid overdoses. In the announcement, the FDA said this is the first time it has proactively developed and tested a DFL for a drug to support development of an OTC product. The model DFL otherwise contains all the key information needed for an untrained bystander to administer naloxone. The goal is to encourage pharmaceutical companies to enter the OTC naloxone market. Any sponsors can use the model DFL . . .