New diabetes drug proposed to FDA
Takeda Pharmaceuticals North America has submitted a New Drug Application (NDA) for a new oral medication that combines pioglitazone HCl and glimepiride, a sulfonylurea, to the US FDA for the treatment of type 2 diabetes.
Takeda Pharmaceuticals North America has submitted a New Drug Application (NDA) for a new oral medication that combines pioglitazone HCl and glimepiride, a sulfonylurea, to the US 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 (pioglitazone HCl) directly targets insulin resistance, while glimepiride acts primarily by increasing the amount of insulin produced by the pancreas. The company is seeking approval to bring the medication to market in the US.