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alert date:

June 16, 2026

FDA Approves OTC Rextovy for Opioid Overdose

The FDA approved Rextovy, another over-the-counter (OTC) naloxone hydrochloride nasal spray for the emergency treatment of opioid overdose. Rextovy was originally approved by the FDA in 2023 as a prescription medication, and this new approval allows consumers to directly purchase this product without a prescription in places such as pharmacies, convenience stores, and online. The approval of Rextovy as an OTC is the third nonprescription naloxone product the agency has approved, helping increase consumer access to naloxone without a prescription. The timeline for availability and the price of this non-prescription product will be determined by the manufacturer. When using Rextovy, some people may experience opioid withdrawal symptoms when they regain consciousness following overdose reversal, such as shaking, sweating, nausea, or feeling angry.

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