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Reviewing Fentora's Existing RiskMAP

Executive Summary

Risk management has been a part of Cephalon's pain products since their initial approval. Actiq was introduced in 1998 with a plan, the first Schedule II opioid analgesic to have one. When Fentora was approved in 2006, it was introduced with a modernized version of RMPs, the Risk Minimization Action Plan. Over time Cephalon has modified the Fentora RiskMAP, which is traced in the company's briefing material for the advisory panel. The most recent update was in February 2008.

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