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Did Takeda Make The Right Decisions Throughout The Uloric Review?

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

When FDA first turned Uloric down for approval, the agency stipulated that the cardiovascular adverse event issue needed further evaluation "by providing further comparative controlled clinical safety data, or, possibly, through reanalyses of the current database." The agency's letter adds, "Should a differential signal of thromboembolic CV events remain upon the analysis of new data and/or reanalyses of existing data, we would strongly encourage you to consider proposing the use of lower doses of Uloric, rather than those proposed."

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