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Takeda Pharmaceuticals Submits New Drug Application For Combo of Actos/Amaryl

Jul 5, 2005

Takeda expects a quick approval.

Takeda Pharmaceuticals North America announced that the company has submitted a New Drug Application (NDA) for a new oral medication that combines pioglitazone HCl and glimepiride, a sulfonylurea, to the United States Food and Drug Administration (FDA) for the treatment of type 2 diabetes.

Takeda submitted a separate NDA for a combination of pioglitazone HCl and metformin HCl in October 2004.

ACTOS(R) (pioglitazone HCl) directly targets insulin resistance, a condition in which the body does not efficiently use the insulin it produces. Glimepiride acts primarily by increasing the amount of insulin produced by the pancreas. These medications work in combination to help patients with type 2 diabetes manage their blood glucose levels. The company is seeking approval to bring the medication to market in the United States.


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ADA 65th Scientific Sessions Poster 1252