Zydus Lifesciences Gets USFDA Nod for Niacin ER Tablets in Multiple Strengths

30 Apr 2025 , 03:28 PM

Zydus Lifesciences Ltd, on 30th April 2025, issued a press note stating that it has received the final United States Food and Drug Administration (USFDA) approval for the production and marketing of Niacin Extended-Release (ER) Tablets USP in 500 mg, 750 mg, and 1,000 mg strengths.

USFDA’s final approval is available for Zydus Lifesciences and group companies, and this will allow the group to sell the product in the highly regulated US market.

Drugs approved are Niacin ER tablets, and they are used for:

• Reducing the levels of total cholesterol (TC), LDL cholesterol, apolipoprotein B, and triglycerides.
• Raising the levels of HDL cholesterol in primary hyperlipidaemia and mixed dyslipidaemia.
• Decrease in recurrent myocardial infarction risk in patients with a history of previous cardiovascular events and abnormal lipid profiles.
• Therapy in adult patients with severe hypertriglyceridemia.

The tablets will be produced at Zydus Group’s formulation facility in Moraiya near Ahmedabad in India. Zydus now has 425 ultimate USFDA approvals following the latest clearance and has submitted a total of 492 ANDAs (Abbreviated New Drug Applications) since FY 2003-04.

At the same time, on April 29, the company completed a surveillance inspection by USFDA at its Gujarat-headquartered Dabhasa API production unit from April 21-25, 2025. The US regulator made six observations after the inspection. Zydus has made it clear that none of them have findings relating to data integrity and stated that corrective steps would be treated on a priority basis.