Latest news with #NiacinExtended-Release
Business Standard
30-04-2025
- Health
- Business Standard
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).
Business Standard
30-04-2025
- Business
- Business Standard
Zydus Life gains after USFDA approval for Niacin Extended-Release tablets
Zydus Lifesciences rose 1.02% to Rs 897 after the pharma company received final approval from the US Food and Drug Administration (USFDA) to manufacture Niacin Extended-Release Tablets USP, 500 mg , 750 mg, and 1,000 mg. The approved medication is indicated for the treatment of patients with primary hyperlipidemia and mixed dyslipidemia. It helps reduce elevated levels of total cholesterol (TC), LDL-C, apolipoprotein B (Apo B), and triglycerides (TG), while increasing HDL-C. It is also used to reduce the risk of recurrent myocardial infarction in patients with a prior history of heart attack and hyperlipidemia and to treat adults with severe hypertriglyceridemia. According to IQVIA MAT (February 2025), the annual sales of Niacin Extended-Release tablets in the U.S. market were estimated at $5.5 million. With this latest approval, Zydus has now secured 425 product approvals and has filed a total of 492 Abbreviated New Drug Applications (ANDAs) since initiating the filing process in FY 200304. Zydus Lifesciences is a discovery-driven, global life sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The company reported a 29.62% jump in consolidated net profit of Rs 1,023.5 crore in Q3 FY25 compared with Rs 789.6 crore in Q3 FY24. Revenue from operations increased 16.96% YoY to Rs 5,269.1 crore during the quarter.
