FDAnews Drug Daily Bulletin

Industry Group Petitions FDA to Withdraw Approvals of Non-Abuse-Deterrent Opioids

July 7, 2017

An industry-funded group has petitioned the FDA to fully transition to opioid painkillers with abuse-deterrent labeling, and to require manufacturers to convert their non-deterrent products.

The Center for Lawful Access and Abuse Deterrence — which counts analgesic manufacturers Endo, Allergan, Depomed and Egalet among its members — petitioned the FDA to withdraw approvals from non-deterrent opioids after the agency has approved three immediate-release or three long-acting abuse-deterrent medications with the same active chemistry.

Given that the FDA has already approved three long-acting, abuse-deterrent formulations of morphine and oxycodone medications, CLAAD said, other manufacturers should either transition or be required to remove their products from the market before July 2020.

View today's stories