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Cephalon Receives Complete Response Letter Regarding Request for Expanded FENTORA Label for Non-Cancer Breakthrough Pain
Date:9/15/2008

FDA Requests Enhancements to Risk Mitigation Strategies Consistent with

Company's Recommendations

FRAZER, Pa., Sept. 15 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH) announced today receipt of a complete response letter from the Food and Drug Administration (FDA) for its supplemental New Drug Application (sNDA) for FENTORA(R) (fentanyl buccal tablet) [C-II] as a treatment for opioid-tolerant patients with non-cancer breakthrough pain. In its letter, the FDA requested that Cephalon implement and demonstrate the effectiveness of proposed enhancements to the current FENTORA risk management program. These enhancements are consistent with the strategies the company presented at the FDA Advisory Board meeting on May 6, 2008. The agency also requested routine safety updates; no additional safety or efficacy studies were requested. In accordance with new FDA regulations, the company anticipates receiving a second communication from the agency requesting that the FENTORA Risk Minimization Action Plan (RiskMAP) be converted to incorporate the new standards for the Risk Evaluation and Mitigation Strategy (REMS) safety plan.

"The FDA request for revisions to the FENTORA risk management program was expected and over the last four months we have been working diligently to prepare for implementation of the program as soon as possible. We anticipate that the subsequent letter from the agency will provide useful guidance to finalize the timeline for and implementation of ongoing enhancements to the risk management program," said Dr. Lesley Russell, Executive Vice President and Chief Medical Officer at Cephalon. "We intend to put into place a REMS that we hope will not only demonstrate effectiveness for mitigating the risks associated with FENTORA but also pave the way for a new industry standard for opioid pain medications."

To address the FDA's request in the complete response letter, Cephalon plans to implement COVERS(
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SOURCE Cephalon, Inc.
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