Zydus Gets USFDA Nod To Launch Niacin Extended-Release Tablets

Zydus Lifesciences Ltd. has received final approval from the US Food and Drug Administration to manufacture and market Niacin extended-release tablets in 500 mg, 750 mg, and 1,000 mg strengths, the company said in an exchange filing on Wednesday.

The tablets will be produced at the company’s manufacturing facility in Moraiya, Ahmedabad.

Niacin extended-release tablets are used to lower total cholesterol, LDL cholesterol, apolipoprotein B, and triglycerides, and to increase HDL cholesterol in patients with primary hyperlipidaemia and mixed dyslipidaemia. They are also indicated to reduce the risk of recurrent heart attacks.

Zydus said the approved product had annual sales of $5.5 million in the US for the 12 months ended February.