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On November 17, 2022, we reported on a preliminary assessment from the US Food and Drug Administration (FDA) that showed certain naloxone products may be approvable for nonprescription use.
The FDA's Federal Register notice included a preliminary assessment that naloxone nasal spray (up to 4 mg) and naloxone autoinjector for intramuscular or subcutaneous use (up to 2 mg) may be approvable as safe and effective for nonprescription use for the prevention of overdose deaths.
"We need additional data such as product-specific data on the nonprescription user interface design, including packaging and labeling, to make a conclusive determination in this respect," wrote the FDA.