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See Latest ArticlesTakeda Receives FDA Complete Response Letter for the Investigational Fixed-Dose Combination of alogliptin and ACTOSÂ for the Treatment of Type 2 Diabetes
Takeda Pharmaceuticals North America, 09/08/09
Takeda Pharmaceutical Company Limited announced that its wholly owned subsidiary, Takeda Global Research & Development Center, Inc. (U.S.), received on September, a complete response letter from the U.S. Food and Drug Administration regarding the New Drug Application for the fixed–dose combination of alogliptin and ACTOS. The FDA informed Takeda on June 2009 that further review of the alogliptin monotherapy NDA would be conditional based upon additional data from a cardiovascular safety study that satisfies the statistical requirements of the December 2008 FDA Guidance titled, “Guidance for Industry: Diabetes Mellitus – Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes.”
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