FDA Releases Naloxone Drug Facts Labels to Spur OTC Development

FDA Commissioner Scott Gottlieb announced that the agency has developed easy-to-understand model drug facts labels (DFLs) to encourage drugmakers to develop an over-the-counter version of the opioid overdose treatment naloxone.

The FDA posted two model DFLs — one for use with a nasal spray and one for use with an auto-injector. The labels contain all the critical information needed for an untrained person to administer the drug, except for the sponsors’ product-specific instructions.

Having naloxone widely available as an approved OTC product, is “an important public health advance and a need that we’ve been working on at the FDA,” Gottlieb said.