Zydus receives USFDA approval for Niacin Extended-Release Tablets

Zydus Lifesciences 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).