Entereg Gets Cautious Approval Recommendation; More Safety Data Needed
Executive Summary
FDA's Gastrointestinal Drugs Advisory Committee overwhelmingly found that GlaxoSmithKline/ Adolor's Entereg (alvimopan) demonstrates convincing efficacy, leading to a positive recommendation for approval, but the panel also expressed concerns about the limited scope of safety data and an inadequate risk management plan
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Entereg’s REMS To Assess Off-Label Use In Quarterly Reports To FDA
Adolor will monitor off-label use of Entereg (alvimopan) under the Risk Evaluation and Mitigation Strategy for the postoperative constipation therapy, but the firm is silent on how it will handle situations of non-compliance with the drug's required controlled distribution system
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