Opioid Abuse-Deterrent Formulations Could Become Prerequisite To Approval

FDA’s Anesthetic and Analgesic Drug Products Advisory Committee recommends against approval of Zogenix’s Zohydro ER as it seeks safer formulations and stricter REMS for all extended-release/long-acting opioids.

FDA is examining the feasibility of requiring abuse-deterrence as a criterion for approving opioids or other abusable drugs.

“As we gain experience with both laboratory and real-world data concerning new opioid products formulated to deter abuse, we are actively considering whether, and under what circumstances, we can and...

More from United States

More from North America