Lupin gets USFDA approval for diabetes management drug

NEW DELHI: Lupin today said it has received final approval from the US health regulator to sell generic diabetes management drug Pioglitazone Tablets in the American market.

Lupin said its US subsidiary, Lupin Pharmaceuticals Inc has received final approval for its Pioglitazone tablets from the US Food and Drugs Administration to market generic version of Takeda Pharmaceuticals USA Inc's Actos tablets.

The company said in a BSE filing that its subsidiary will shortly commence marketing the product.

The approval has been granted for tablets in strengths of 15 mg, 30 mg and 45mg.

"Lupin's Pioglitazone tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings," the company said.

As per IMS MAT December data, Actos tablets had annual US sales of USD 236 million.