FDA approves new REMS for fentanyl-based painkillers

New program combines multiple REMS into one

SILVER SPRING, Md. — The Food and Drug Administration is streamlining the enrollment process for risk evaluation and mitigation strategies for a class of painkillers, the agency said Tuesday.

The FDA announced the approval of a single REMS for transmucosal immediate-release fentanyl, or TIRF, drugs. The new system, which takes effect in March, will allow prescribers and pharmacies to enroll into one system instead of individual systems for each product. TIRF drugs include ProStrakan's Abstral, Cephalon's Fentora and Actiq, Archimedes Pharma's Lazanda and Meda Pharmaceuticals' Onsolis.

"This TIRF REMS will ensure safe use and access to these drugs for patients who need them," FDA Center for Drug Evaluation and Research director Janet Woodcock said. "We have worked with the sponsors of both the innovator and generic drugs to develop this single, shared system that will streamline the process and decrease the burden of the REMS on the healthcare system."


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