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FDA’s Strongest REMS To Date: Entereg Approved With Controlled-Distribution

Executive Summary

Adolor and marketing partner GlaxoSmithKline's post-operative constipation therapy Entereg is the first drug to clear FDA with its highest level of Risk Evaluation and Mitigation Strategy - a required controlled distribution program. Entereg is at least the fifth new drug, and the second new molecular entity, to be approved with a REMS since the new authority granted by the FDA Amendments Act went into effect March 25

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