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FDA unveils REMS for fentanyl drugs

December 30, 2011 1:31 AM UTC

FDA approved a single REMS for the class of transmucosal immediate-release fentanyl pain drugs to reduce the risk of misuse, abuse, addiction and overdose. The shared REMS, which takes effect in March, will replace separate REMS that are in place for each product. It will require prescribers and pharmacies to enroll in the shared program to prescribe or dispense the drugs for outpatient use. Prescribers and pharmacies already enrolled in an individual REMS will automatically be transferred to the shared program.

Marketed drugs in the class include Abstral from ProStrakan Group plc; Actiq and Fentora from Cephalon Inc.; Lazanda from Archimedes Pharma Ltd. (Reading, U.K.); and Onsolis from BioDelivery Sciences International Inc. (NASDAQ:BDSI) and Meda AB (SSE:MEDAA). ProStrakan is part of Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151). Cephalon is part of Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA). ...