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FDA Requests Cephalon to Enhance Risk Mitigation Strategies Consistent with Company's Recommendations

Posted on September 24, 2008

This is not exactly under the headline of news - a Complete Response Letter (CRL) was issued to Cephalon on the 15th of September 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. But there are two things new on the regulatory scene - CRLs and Risk Evaluation and Mitigation Strategies (REMS), a by-product of the Food and Drug Administration Amendments Act (FDAAA). This letter allows us the opportunity to study both. Comments are written in upper case. FRAZER, Pa....

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addiction , cancer , chronic pain