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Relistor Can Be Approved For Chronic Pain Patients With Constipation, FDA Says

This article was originally published in The Pink Sheet Daily

Executive Summary

Agency grants Salix/Progenics’ appeal seeking a chronic use indication for the mu opioid receptor antagonist without the need for additional clinical data on cardiovascular safety pre-approval. Decision also bodes well for AstraZeneca’s Movantik, which has a September user fee deadline.

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