Home » FDA Releases Naloxone Drug Facts Labels to Spur OTC Development
FDA Releases Naloxone Drug Facts Labels to Spur OTC Development
January 24, 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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