Zydus Lifesciences receives USFDA approval for Niacin Extended-Release Tablets
Zydus Lifesciences Ltd. has received final approval from the USFDA to manufacture Niacin Extended-Release Tablets USP, 500 mg, 750 mg, and 1,000 mg. Niacin is indicated to reduce elevated total cholesterol, LDL cholesterol, apolipoprotein B, and triglycerides, and to increase HDL cholesterol 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. The 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).
Key Highlights
- Zydus Lifesciences receives final approval from USFDA for Niacin Extended-Release Tablets USP, 500 mg, 750 mg, and 1,000 mg
- Niacin is indicated to reduce elevated total cholesterol, LDL cholesterol, apolipoprotein B, and triglycerides, and to increase HDL cholesterol
- The 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)
- Zydus now has 425 USFDA approvals and has so far filed 492 ANDAs since the commencement of the filing process in FY 2003-04