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BioPharmaceutical United States Regulation

Cardiovascular Outcomes Trials For Opioid Agonists To Get FDA Panel Review

This article was originally published in The Pink Sheet Daily

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Executive Summary

Salix and Progenics’ appeal of FDA’s “complete response” letter for Relistor argues that potential safety issues for the opioid-induced constipation claim could be handled in a post-marketing study.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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