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1 July 20265 min read
Medicine
FDA Approves Rextovy as Another Over-the-Counter Naloxone Nasal Spray
The 4 mg intranasal naloxone product can be sold directly to consumers without a prescription, adding another nonprescription option for emergency opioid-overdose reversal.
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The US Food and Drug Administration approved Rextovy, a 4 mg naloxone hydrochloride nasal spray, for over-the-counter emergency treatment of opioid overdose on 16 June.
FDA says consumers will be able to purchase the intranasal product without a prescription in pharmacies, convenience stores and online. The agency granted the approval to Amphastar Pharmaceuticals.
The agency says another approved naloxone formulation can broaden access, improve market availability, encourage competition and provide alternative sourcing options.
Sourcing note: Approval status, dose, indication, sponsor and safety instructions are from FDA.
Why It Matters
Over-the-counter naloxone only matters if people can obtain it quickly, understand how to use it and call emergency services. Another approved product may improve supply resilience and competition.
Primary Sources
Our sourcing: Cedar S. Insights provides source-led editorial analysis. Reported company, institutional and regulatory claims are attributed to their original sources unless stated otherwise.
Corrections: If a material factual error is identified, Cedar S. Insights will update the relevant article and preserve the distinction between the corrected statement and supporting evidence.
Topics
FDANaloxoneOpioid OverdoseOver-the-Counter MedicinesPublic Health