Zydus Wins USFDA Approval for Cholesterol Drug

30 Apr 2025 , 11:25 PM

Zydus Lifesciences Ltd on April 30 announced that it has got final US Food and Drug Administration (USFDA) approval for Niacin Extended-Release Tablets USP. The approval is for 500 mg, 750 mg, and 1,000 mg strengths. The medicine is used to manage cholesterol levels in patients. The USFDA approval also covers Zydus’ affiliates and subsidiaries.

The medication reduces total cholesterol, LDL cholesterol, apolipoprotein B, and triglycerides. It also increases HDL cholesterol in patients with primary hyperlipidaemia and mixed dyslipidaemia.

The medication is also prescribed to lower the risk of another heart attack in individuals with a past history of myocardial infarction and hyperlipidaemia. It lowers triglycerides in adults with very severe hypertriglyceridemia. Zydus announced the approved tablets will be manufactured in its topical manufacturing facility in Moraiya, Ahmedabad.

As of 31st March, 2025, Zydus received 425 final approvals and has submitted 492 ANDAs after FY 2003–04. In yet another update, the company was successful in undergoing a USFDA surveillance inspection of its API plant at Dabhasa, Gujarat.

It was conducted from April 21 to April 25. The USFDA mentioned six points during the inspection. Zydus made sure that no observations related to data integrity were made. The organization is confident about satisfying all the points indicated in the inspection.