FDA issues guidance for generic abuse-deterrent opioids

FDA issued draft guidance for developers of generic versions of approved opioids with abuse-deterrent properties described in their labels.

The guidance outlines the studies an ANDA sponsor should conduct to demonstrate a generic is no less abuse-deterrent than its reference product on all potential routes of abuse. This includes comparative in vitro studies using a tier-based approach to compare mechanical and chemical manipulation of the generic vs. the reference opioid. ...