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FDA Moves Toward Making Overdose Antidote an Over-the-Counter Drug


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By Physician’s Briefing Staff HealthDay Reporter>

WEDNESDAY, Nov. 16, 2022 — The U.S. Food and Drug Administration appears poised to approve certain naloxone products for over-the-counter use, a move that would help fight the nation’s opioid epidemic.

On Tuesday, the FDA issued a Federal Register notice that could lead to some prescription naloxone products getting approved for over-the-counter sales. The notice could also encourage development of new nonprescription naloxone products.

“Today’s action supports our efforts to combat the opioid overdose crisis by helping expand access to naloxone,” FDA Commissioner Robert Califf, M.D., said in an agency news release. “The agency will keep overdose prevention and reduction in substance use disorders as a key priority and area of intense strategic focus for action as rapidly as possible.”

The notice cites a preliminary assessment that a naloxone nasal spray and an autoinjector “may be approvable as safe and effective for nonprescription use.” However, it is not a final decision or a mandate to make naloxone products available without a prescription. The FDA said it still needs more data, including packaging and labeling information, before it makes a final recommendation.

This is the latest FDA effort to improve access to naloxone products to stop overdoses as they happen. In September, the agency clarified that certain Drug Supply Chain Security Act requirements do not apply to naloxone.

The FDA has also developed a model drug facts label that includes easy-to-understand pictograms. This is meant to encourage manufacturers to seek approval for over-the-counter naloxone products. Another measure extended the shelf life of naloxone nasal spray from 24 months to 36 months.

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