FDA Has Model Drug Facts Labels For OTC Naloxone, Wants Switch Proposals
Executive Summary
Development of the model DFLs was a first for agency, reflecting alarm over public health crisis of overdoses from opioid abuse, which reached nearly 48,000 in 2017. The project was "part of our broader commitment to addressing the opioid crisis" and should help sponsors with potential naloxone OTC switch NDAs, says Commissioner Scott Gottlieb.
You may also be interested in...
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 label 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.
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.
OTC Naloxone NDA First Module Filed With US FDA
Module comprising clinical study reports submitted in accordance with Harm Reduction Therapeutics’ rolling review proposal accepted by FDA after the agency in July granted fast track status for the application.