FDA approve a shared REMS for all transmucosal fentanyl products
20th February 2012
The US Food and Drug Administration (FDA) have approved a shared Risk Evaluation and Mitigation Strategy (REMS) for all Transmucosal Immediate Release Fentanyl (TIRF) products. This shared program has been designed to streamline the REMS process and will allow prescribers and pharmacists to enrol in one shared REMS system for all TIRF products. The branded fentanyl products currently included are; Abstral (sublingual tablet), Actiq (lozenge), Fentora (buccal tablet), Lazanda (nasal spray), Onsolis (buccal soluble film) and Subsys (sublingual spray), the website will be available in March 2012.
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