In a first for the agency, the FDA has developed and tested a consumer-friendly Drug Facts label to support the development of an over-the-counter version of naloxone, an emergency opioid overdose treatment.
A DFL is required for OTC drug products and the FDA has never before proactively developed and tested one. But in this case, the agency wanted to create “model labeling that sponsors can use to obtain approval for OTC naloxone and increase its access,” according to FDA chief Dr. Scott Gottlieb.
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