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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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PharmAsia News Business Bulletin

A regular roundup of commercial stories appearing in Scrip’s sister publication PharmAsia News, whose multilingual team of regional experts provides authoritative business intelligence focused on the Asian marketplace. Full stories can be accessed by clicking on the story title (subscription required).




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