Lupin, one of the leading pharmaceutical companies in India, today announced that it has received final approval for its Pioglitazone tablets USP, 15 mg, 30 mg and 45 mg from the United States Food and Drugs Administration (FDA) to market a generic version of Takeda Pharamaceuticals USA (Takeda) Actos tablets, 15 mg, 30 mg and 45 mg.
Lupin Pharmaceuticals, 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 2 diabetes mellitus in multiple clinical settings.
Actos tablets had annual US sales of USD 236 million.
Shares of the company gained Rs 15.2, or 1.58%, to trade at Rs 976.10. The total volume of shares traded was 24,670 at the BSE (2.28 p.m., Wednesday).