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Takeda Provides Update on the Investigational Fixed-Dose Combination of alogliptin and ACTOS(R) (pioglitazone HCl)
Date:7/22/2009

DEERFIELD, Ill., July 22, and OSAKA, Japan, July 23 /PRNewswire/ -- Takeda Pharmaceutical Company Limited ("Takeda") today announced that Takeda Global Research & Development Center, Inc., a wholly owned United States (U.S.) subsidiary, received notification from the U.S. 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((R)) (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.

About ACTOS((R)) (pioglitazone HCl)

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.

Important Safety Information About ACTOS

ACTOS is not for everyone. Certain patients with heart failure should not start taking ACTOS. ACTOS can cause new, or worsen, heart fail
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SOURCE Takeda Pharmaceutical Company Limited
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