The US Food and Drug Administration took a second unprecedented step in spurring development of OTC naloxone products by publishing a notice identifying data and other information needed in new drug applications for nonprescription access.
US FDA Serves Notice: Approval Of OTC Naloxone Could Close Prescription Sales
Agency signals assurance about making naloxone available OTC, so much so that firms with approved NDAs for Rx products should prepare for an all-nonprescription market. After offering model DFl to spur OTC switch NDAs, FDA notice about OTC assessment is second unprecedented step on its naloxone journey since opioid crisis declared a public health emergency in 2017.
