Zydus Gets USFDA Nod to Market Generic Niacin ER Tablets in US

Zydus Lifesciences Ltd has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market the generic version of Niacin extended-release tablets, a cholesterol-lowering medication. The company announced on Wednesday that the approved strengths include 500 mg, 750 mg, and 1,000 mg tablets. This clearance marks another milestone in Zydus’s efforts to expand its generics portfolio in the U.S. pharmaceutical market.

According to the company’s regulatory filing, the approved product will be manufactured at Zydus’s facility located in Moraiya, near Ahmedabad. This site is a key production hub for the group and has previously supported various USFDA-approved products.

Niacin extended-release is prescribed for patients suffering from primary hyperlipidaemia and mixed dyslipidaemia. The drug helps reduce elevated levels of total cholesterol, low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), and triglycerides (TG), while boosting high-density lipoprotein cholesterol (HDL-C). Additionally, it is used to lower the risk of recurrent heart attacks in patients with a history of myocardial infarction and elevated lipid levels. The drug is also indicated for adults with severe hypertriglyceridemia.

Citing data from IQVIA MAT for February 2025, Zydus stated that the U.S. market for Niacin extended-release tablets stood at approximately USD 5.5 million in annual sales, reflecting a steady demand for the medication. This approval strengthens Zydus’s presence in the cardiovascular therapeutic segment and reinforces its commitment to offering affordable, quality-driven healthcare solutions in global markets.