Takeda Resubmits NDAs for Alogliptin and the Fixed-Dose Combination 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.
Takeda Pharmaceutical Company Limited (Takeda) announced that its wholly-owned subsidiary, Takeda Global Research & Development Center, Inc., resubmitted New Drug Applications (NDAs) to the 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.
"Takeda was able to respond to the FDA promptly with significant new data from our ongoing clinical trial program and updated postmarketing data from outside the U.S.," said David Recker, M.D., senior vice president, clinical science, Takeda Global Research & Development Center, In
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