Zydus Lifesciences gains on getting USFDA’s final 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 $5.5 million 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 (formerly known as Cadila Healthcare), a company limited by shares, incorporated and domiciled in India, operates as an integrated pharmaceutical company with business encompassing the entire value chain in the research, development, production, marketing and distribution of pharmaceutical products.