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FDA Broadens Access to Life-Saving Opioid Overdose Treatment Drug

FDA Broadens Access to Life-Saving Opioid Overdose Treatment Drug

The FDA has approved Rextovy (naloxone HCI) nasal spray 4 mg as an over-the-counter drug for the emergency treatment of opioid overdose.

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FDA in Action

Ensuring Quality and Access: FDA’s Approach to Generic Drug Oversight
Guidance shows how sponsors can build on existing science, reduce redundant testing and accelerate treatments
FDA Achieves Year 1 Goals in Reducing Animal Testing in Drug Development
FDA Releases Results from Largest-Ever Testing of Infant Formula in the U.S.
FDA PreCheck Pilot Program Strengthens Domestic Pharmaceutical Manufacturing
Agency Unveils Real-Time Trial Proofs-of-Concept and Upcoming Pilot Program
FDA Finalizes Food Chemical Safety Post-Market Assessment Program, Launches Reassessment of BHT, ADA

Press Announcements

June 16, 2026

FDA Broadens Access to Over-the-Counter Naloxone Nasal Spray for Opioid Overdose

June 15, 2026

FDA Approves New Indication for Tzield (teplizumab) for Certain Pediatric Patients with Recently Diagnosed Stage 3 Type 1 Diabetes

June 12, 2026

FDA Clears First Over-the-Counter Continuous Glucose Monitor for Children

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