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Takeda Gets Second Chance With U.S. FDA Complete Response On Actos Combo Drug

This article was originally published in PharmAsia News

Executive Summary

Osaka-based Takeda Pharmaceutical stated this week that it has received a complete response letter from U.S. FDA; the American drug regulator stated in the letter that the NDA review for a fixed-dose alogliptin and Actos (pioglitazone) combo drug will depend on additional data from a cardiovascular safety study FDA requested for the company's alogliptin monotherapy NDA

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