Lupin has received final approval for its pioglitazone tablets USP, 15 mg, 30 mg, and 45 mg from the United States Food and Drugs Administration (US FDA) to market a generic version of Takeda Pharmaceuticals USA, (Takeda) Actos tablets, 15 mg, 30 mg, and 45 mg. Lupin Pharmaceuticals Inc. (LPI), the company’s US subsidiary would commence marketing the product shortly.
Lupin’s pioglitazone tablets USP, 15 mg, 30 mg, and 45 mg are the AB-rated generic equivalents of Takeda’s Actos tablets 15 mg, 30 mg, and 45 mg and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type II diabetes mellitus in multiple clinical settings.
Actos tablets had annual US sales of $236 million (IMS MAT Dec, 2013).
EP News Bureau – Mumbai