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FDA Approves ACTOplus met(R) XR (pioglitazone HCl and metformin HCl extended-release) Tablets for the Treatment of Type 2 Diabetes
Date:5/13/2009

First and only oral antidiabetic fixed-dose combination medication approved with the extended-release form of metformin

DEERFIELD, Ill. and OSAKA, Japan, May 13 /PRNewswire/ -- Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc., today announced that the U.S. Food and Drug Administration (FDA) approved an extended-release version of the combination medication ACTOplus met(R) (pioglitazone HCl and metformin HCl) as an adjunct to diet and exercise for the treatment of type 2 diabetes. ACTOplus met(R) XR is the first and only prescription oral antidiabetic fixed-dose combination medication available with the extended-release form of metformin to help improve glycemic control in a convenient, once-daily dosing option. ACTOplus met XR is indicated for adults with type 2 diabetes who are already treated with ACTOS(R) (pioglitazone HCl) and metformin or who have inadequate glycemic control on ACTOS or metformin alone.

ACTOplus met XR combines ACTOS and metformin, two widely used medications in a single tablet. ACTOS directly targets insulin resistance, a condition in which the body does not efficiently use the insulin it produces. Metformin acts by reducing the amount of glucose produced by the liver. These medications work in combination to help patients with type 2 diabetes manage their blood glucose levels.

Extended-release metformin, one of the active ingredients in ACTOplus met XR, was developed by Watson Laboratories, a subsidiary of Watson Pharmaceuticals, Inc. and licensed to Takeda Pharmaceutical Company Limited. Takeda expects ACTOplus met XR to be available later this calendar year.

About Type 2 Diabetes

Diabetes has reached epidemic proportions in the United States. Almost 24 million people currently live with diabetes and, of these, 5.7 million are unaware that
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SOURCE Takeda Pharmaceutical Company Limited
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