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Shared REMS For Transmucosal Fentanyls Could Expand Market For Meda’s Onsolis As It Exits More Restrictive Program

 
• By Cathy Dombrowski

Class-wide Risk Evaluation and Mitigation Strategy for transmucosal immediate-release fentanyl products will begin operations in March 2012, with participants in REMS for individual products to be transitioned automatically to the new system.

The first shared system to implement a Risk Evaluation and Mitigation Strategy for a class of opioids will begin operating in March 2012 with the debut of the TIRF REMS Access program for transmucosal immediate-release fentanyl products.

FDA on Dec. 29 approved the class-wide REMS for fentanyl drugs requiring out-patient prescribers, pharmacies, wholesalers and distributors to enroll in TIRF REMS Access. Those already enrolled in REMS programs...

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