Naloxone Efficacy Standard Changes Could Impact Amphastar's Pending NDA
Executive Summary
FDA is reviewing Amphastar’s application for a new intranasal formulation at the same time it is reconsidering minimum pharmacokinetic standards for the opioid overdose reversal agent.
You may also be interested in...
Amphastar's Naloxone Nasal Spray Delayed; User Human Factors Study Among FDA Concerns
FDA 'complete response' letter follows advisory committee's conclusion that the current naloxone approval standard is inadequate.
Unapproved Petitioner: Clinical-Stage Firm Wants FDA Scrutiny Of Naloxone Formulations
Mucodel has a oromucosal naloxone product in Phase I, and it wants US FDA to reconsider approval standards for intranasal products that are further along in development.
Drug Abuse And US Presidential Politics: Surprising Bipartisan Agreement
Donald Trump has a knack from making headlines, and produced a doozy when he called for drug tests of Hillary Clinton before the next Presidential debate; beneath the hoopla, however, was an important point of substance: the two campaigns actually agree that advancing addiction treatment is a high priority for federal action.