FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Releases Naloxone Drug Facts Labels to Spur OTC Development

Jan. 25, 2019

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.

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