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March 29, 2023

FDA Approves First OTC Naloxone Nasal Spray

The FDA approved Narcan (naloxone hydrochloride) 4mg nasal spray for over-the-counter (OTC) use – the first naloxone product approved for use without a prescription. Naloxone rapidly reverses the effects of opioids and is the standard treatment for opioid overdose. As opioid pain medications are commonly used in workers’ comp and come with risk of overdose even when used properly, this approval makes this life-saving drug more accessible for injured worker patients. The approval may also affect the status of other brand-name naloxone nasal spray products of 4 mg or less, but determinations will be made on a case-by-case basis and the FDA may contact other firms as needed.

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