Zydus Lifesciences wins USFDA okay for cholesterol-lowering drug Niacin Extended Release
Ahmedabad: Zydus Lifesciences Limited has announced that the company has received final approval from the United States Food and Drug Administration (USFDA) to manufacture Niacin Extended-Release Tablets USP, 500 mg, 750 mg, and 1,000 mg (Niaspan Extended-Release Tablets, 500 mg, 750 mg, and 1,000 mg).
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 in adult patients with severe hypertriglyceridemia.
Niacin-Extended-Release tablets will be produced at the Group’s manufacturing site at Moraiya, Ahmedabad.
Niacin-Extended-Release tablets had annual sales of USD 5.5 mn in the United States (IQVIA MAT February 2025).
The group now has 425 approvals and has so far filed 492 ANDAs since the commencement of the filing process in FY 2003-04.
Zydus Lifesciences Ltd. is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group has a significant presence in cancer related therapies and offers a wide range of solutions with cytotoxic, supportive & targeted drugs.
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