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Lacking A Clear Disease Setting, Sanofi’s Semuloparin Fails ODAC Vote

Executive Summary

It isn’t clear to either FDA or the Oncologic Drugs Advisory Committee what specific cancer chemotherapy setting would be the most useful for Sanofi-Aventis’ semuloparin, a low molecular weight heparin intended to prevent venous thromboembolism.

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Sanofi-Aventis’ Semuloparin May Have Safety Advantage For ODAC To Consider

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