Zydus Lifesciences Secures USFDA Approval for Cholesterol Drug

Zydus Lifesciences has received USFDA approval to manufacture generic Niacin extended-release tablets. These tablets, used to manage cholesterol levels and reduce myocardial infarction risk, will be produced at their Ahmedabad facility. The market for these tablets in the U.S. is valued at USD 5.5 million.

Zydus Lifesciences Ltd announced on Wednesday that it has obtained final approval from the US Food and Drug Administration (USFDA) to manufacture a generic version of Niacin extended-release tablets, which are used to lower cholesterol levels.

The approval allows for the production of the tablets in 500 mg, 750 mg, and 1,000 mg strengths at Zydus's Moraiya, Ahmedabad manufacturing site. This development represents a significant step in the company's expansion within the global pharmaceutical market, especially in the cardiovascular segment.

According to IQVIA MAT data as of February 2025, the annual sales of these tablets in the United States market amounted to USD 5.5 million, highlighting its commercial viability and the potential impact of this new generic option.

(With inputs from agencies.)