FDA May Approve Naloxone for Nonprescription Use

The FDA is considering whether some versions of the overdose reversal drug naloxone may be approvable for nonprescription use.

“We believe the prescription requirement for these naloxone products might not be necessary for the protection of the public health,” the FDA said.

The agency added that it needs additional information, such as product-specific data on packaging and labeling to make a conclusive determination.

The agency said that its preliminary opinion is that naloxone nasal spray up to 4 mg and naloxone autoinjector for intramuscular or subcutaneous use up to 2 mg “have the potential to be safe and effective for use as directed in nonprescription drug labeling without the supervision of a healthcare practitioner.”