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Takeda Global Research & Development Center, Inc. received a complete response letter from the FDA regarding its NDA for the fixed-dose combination of alogliptin and Actos (pioglitazone HCl).
September 4, 2009
By: Tim Wright
Editor-in-Chief, Contract Pharma
Takeda Global Research & Development Center, Inc. received a complete response letter from the FDA regarding its NDA for the fixed-dose combination of alogliptin and Actos (pioglitazone HCl). In June, the FDA said that further review of the NDA would be conditional based on additional data from a cardiovascular safety study that satisfies the requirements of the December 2008 FDA Guidance titled, “Guidance for Industry: Diabetes Mellitus – Evaluating Cardiovascular Risk in New An...
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