“The FDA announced new efforts to expand naloxone access Thursday by making it easier for companies to make over-the-counter (OTC) versions of the opioid overdose treatment.
Naloxone is not yet available OTC, prompting the FDA to try streamlining the label-development process by proactively creating two Drug Fact Label (DFL) templates to support OTC nasal spray and injectable products. DFLs are the consumer-friendly instructions that must accompany OTC drugs. Normally, applicants seeking approval for OTC status propose and test the DFL. This is the first time the agency has created and tested DFLs itself, said FDA Commissioner Scott Gottlieb, MD.
“One of the key components for OTC availability is now in place,” he said in a statement. “In short, we’ve crafted model labeling that sponsors can use to obtain approval for OTC naloxone and increase its access.””
Source: MedPageToday.com – January 17, 2019
See original press release: Statement from FDA Commissioner Scott Gottlieb, M.D., on unprecedented new efforts to support development of over-the-counter naloxone to help reduce opioid overdose deaths available at: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm629571.htm