OTC Naloxone NDA First Module Filed With US FDA
Executive Summary
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.
You may also be interested in...
OTC Naloxone NDA In US Gets Fast Track Status
Nonprofit HRT reached a commercial supply agreement for a firm to produce its RiVive naloxone nasal spray still in development after FDA granted fast frack designation for its OTC switch NDA.
OTC Naloxone May Get Another Push From US FDA As Agency Prepares Novel Switch Proposed Rule
Financial model isn't adequate currently, FDA Commissioner Robert Califf says, and agency may make regulatory changes to motivate sponsors.
Naloxone OTC Switch Urged By Congressional Coalition Of 30 Democrats And Republicans
In response to highest number of overdose deaths in US history in 2021, 30 members from both chambers of Congress sign letters sent to seven CEOs of naloxone manufacturers.