Zydus Lifesciences gets USFDA nod for generic cholesterol lowering drug

Zydus Lifesciences Ltd on Wednesday said it has received final approval from the US health regulator to manufacture the generic version of cholesterol lowering Niacin extended-release tablets. The approval by the US Food and Drug Administration (USFDA) is for Niacin extended-release tablets of strengths 500 mg, 750 mg, and 1,000 mg, Zydus Lifesciences Ltd said in a regulatory filing.

The Niacin-extended-release tablets will be produced at the group's manufacturing site at Moraiya, Ahmedabad, the company said.

Niacin is indicated to reduce elevated total cholesterol (TC), LDL cholesterol (LDL-C), apolipoprotein B (Apo B), and triglycerides (TG), and to increase HDL cholesterol (HDL-C) in patients with primary hyperlipidaemia and mixed dyslipidaemia.

It is also indicated to reduce the risk of recurrent myocardial infarction in patients with a history of myocardial infarction and hyperlipidaemia and to reduce TG (triglyceride) in adult patients with severe hypertriglyceridemia.

Citing IQVIA MAT February (2025) data, the company said the niacin-extended-release tablets had annual sales of USD 5.5 million in the United States.