Zydus gets USFDA final approval for Niacin Extended-Release Tablets
Zydus Lifesciences Limited, along with its subsidiaries and affiliates (collectively referred to as 'Zydus'), has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Niacin Extended-Release Tablets USP in 500 mg, 750 mg, and 1,000 mg strengths. These tablets are the generic version of Niaspan® Extended-Release Tablets.
Niacin Extended-Release Tablets are used in the management of lipid disorders. They are indicated to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), and triglycerides (TG), while increasing high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hyperlipidaemia and mixed dyslipidaemia. The drug is also approved to reduce the risk of recurrent myocardial infarction in patients with a prior heart attack and hyperlipidaemia, and to treat severe hypertriglyceridemia in adults.
The approved product will be manufactured at Zydus' facility in Moraiya, Ahmedabad.
According to IQVIA MAT data for February 2025, annual sales of Niacin Extended-Release Tablets in the United States were approximately USD 5.5 million.
With this approval, Zydus now has a total of 425 Abbreviated New Drug Application (ANDA) approvals and has filed 492 ANDAs since it began filing in the financial year 2003-04.
Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at BusinessUpturn.com
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