Zydus Lifesciences Gets US FDA Final Nod for Niacin Extended-Release Tablets

MT Newswires Live

2025/04/30

Zydus Lifesciences (NSE:ZYDUSLIFE, BOM:532321) has received final approval from the US Food and Drug Administration to manufacture Niacin Extended-Release Tablets, according to a Wednesday filing to the Indian stock exchanges.

Niacin is indicated to reduce elevated total cholesterol, LDL cholesterol, apolipoprotein B, and triglycerides (TG), and to increase HDL cholesterol in patients with primary hyperlipidaemia and mixed dyslipidemia.

These tablets will be produced at the group's Moraiya manufacturing site in Ahmedabad, India.

As per IQVIA data, Niacin-Extended-Release tablets recorded annual sales of $5.5 million in the US.

The company's shares were up nearly 1% in recent trade.

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