(+) Takeda resubmits New Drug Applications to the United States Food and Drug Administration for alogliptin and the fixed-dose combination alogliptin and pioglitazone (PRNewswire) - Jul 27, 2012 - Takeda announced that its wholly-owned subsidiary, Takeda Global Research & Development Center, resubmitted NDAs to the US FDA for alogliptin and fixed-dose combination (FDC) alogliptin and pioglitazone; Takeda anticipates that these applications will be reviewed within the next six months; This 2012 resubmission includes additional data from three P3 clinical trials involving more than 3,275 pts conducted at 1,384 centers worldwide
NDA • Diabetes
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Takeda Pharmaceutical Company Limited (Takeda) announced today that its wholly-owned subsidiary, Takeda Global Research & Development Center, Inc., resubmitted New Drug Applications (NDAs) to the United States (U.S.) Food and Drug Administration (FDA) for alogliptin and fixed-dose combination (FDC) alogliptin and pioglitazone. Takeda anticipates that these applications will be reviewed within the next six months. These NDAs were resubmitted in response to the complete response letter Takeda received from the FDA, dated April 25, 2012.
This 2012 resubmission includes additional data from three phase 3 clinical trials involving more than 3,275 patients conducted at 1,384 centers worldwide. When combined with previously submitted phase 3 clinical data, which included more than 8,000 patients conducted in more than 1,000 centers worldwide, nearly 10,000 patients have been treated with alogliptin in the clinical development programs to date...
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