Takeda Pharmaceutical Company Limited announced that Takeda Global Research & Development Center, Inc, a wholly owned US subsidiary, received notification from the US Food and Drug Administration (FDA) that the FDA extended the review of the New Drug Application (NDA) for the fixed-dose combination (FDC) of alogliptin and Actos (pioglitazone HCl). The new Prescription Drug User Fee Act (PDUFA) date for the FDC is September 4, 2009.

The NDA for the FDC of alogliptin and Actos was submitted in September 2008, following the NDA submission of alogliptin monotherapy in December 2007. On March 6, 2009 the FDA informed Takeda that based on the December 2008 FDA Guidance titled, "Guidance for Industry: Diabetes Mellitus - Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes," the amount of existing alogliptin clinical data in the alogliptin monotherapy NDA was not sufficient to meet certain statistical requirements outlined in that Guidance. On June 26, the FDA asked Takeda to conduct an additional cardiovascular safety trial that satisfies the December 2008 FDA Guidance for alogliptin.

Actos is a prescription medication used with diet and exercise to improve blood sugar (glucose) control in adults with type-2 diabetes. Actos is not for patients with type-1 "juvenile" diabetes or diabetic ketoacidosis. ACTOS has not been studied in children and is not recommended for children under the age of 18. ACTOS may be taken alone or with a sulfonylurea, metformin, or insulin.

Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products.