US FDA kicks 'moderate' out of ER/LA opioid pain indication, adds postmarket studies requirement
This article was originally published in SRA
Executive Summary
US regulators have ordered makers of extended-release (ER) and long-acting (LA) opioids, such as morphine, oxycodone and fentanyl, to add new warnings to the labeling of their products and revise the indications of the medicines as part of an effort to help curb the abuse and misuse of the drugs1,2.