Zydus Lifesciences Receives USFDA Approval for Niacin-Extended-Release Tablets

Zydus Lifesciences Limited has earned USFDA approval for Niacin Extended-Release Tablets used to treat high cholesterol. Manufactured in Ahmedabad, these tablets also help prevent heart attacks. The company, with 425 approvals to date, continues to expand its pharmaceutical offerings globally.

Zydus Lifesciences Limited, a major Indian pharmaceutical company, has secured final approval from the United States Food and Drug Administration (USFDA) to produce Niacin Extended-Release Tablets. This medication is designed to lower elevated total cholesterol, LDL cholesterol, apolipoprotein B, and triglycerides while increasing HDL cholesterol in patients with primary hyperlipidemia and mixed dyslipidemia.

The tablets are also intended to minimize the risk of recurrent myocardial infarction in those with a history of heart attacks and hyperlipidemia. Additionally, they can lower triglyceride levels in adults with severe hypertriglyceridemia. Zydus Lifesciences will manufacture these tablets at their facility in Moraiya, Ahmedabad, as per the company's filing with the stock exchanges.

The annual sales of Niacin-Extended-Release tablets in the United States reached USD 5.5 million, according to IQVIA data from February 2025. With this latest product, Zydus has a total of 425 approvals and has filed 492 ANDAs since fiscal year 2003-04. On April 11, the company also received USFDA approval to produce Jaythari (Deflazacort) Tablets, indicated for treating Duchenne muscular dystrophy in patients aged five and older.

Zydus Lifesciences Limited, formerly Cadila Healthcare Limited, is a leading global healthcare provider with a robust presence across the pharmaceutical value chain. Established in 1952 and restructured in 1995, the company has shown substantial financial growth, achieving a turnover exceeding Rs 19,500 crores in the fiscal year 2024.

(With inputs from agencies.)