Takeda Provides Update On Combination Of Alogliptin And ACTOS
Published: 22-Jul-2009
FDA has extended the review of the New Drug Application
Takeda Global Research & Development Center has received notification from the FDA that it has extended the review of the New Drug Application (NDA) for the fixed-dose combination of alogliptin and ACTOS (pioglitazone HCl).
The NDA for alogliptin and ACTOS was submitted in September 2008, following the NDA submission of alogliptin monotherapy in December 2007.
On March 6, 2009, FDA informed Takeda that based on December 2008 FDA Guidance, the amount of existing alogliptin clinical data in the alogliptin monotherapy NDA, was not sufficient to meet certain statistical requirements. On June 26, FDA asked Takeda to conduct an additional cardiovascular safety trial that satisfies the December 2008 FDA Guidance for alogliptin.
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