nov 21, 2017 - FDA issued a final guidance titled “General
Principles for Evaluating the Abuse Deterrence of
Generic Solid Oral Opioid Drug Products.” This
guidance recommends studies, including
comparative in vitro and pharmacokinetic
studies, that the potential abbreviated new drug
application (ANDA) applicant should conduct and
submit to FDA in an ANDA to demonstrate that a
generic solid oral opioid drug product is no less
abuse-deterrent than its reference listed drug
with respect to all potential routes of
Added to timeline:
Opioids and the FDA
Date:
