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.
