Lupin Gets U.S. FDA Nod For Generic Drug

Drug maker Lupin on Wednesday said it has received approval from the U.S. health regulator to market a generic medication which is used to treat primary biliary cholangitis.

The company has received approval from the U.S. Food and Drug Administration for Obeticholic Acid tablets (5 mg and 10 mg), the Mumbai-based drug maker said in a statement.

The company's product is a generic equivalent of Intercept Pharmaceuticals, Inc's Ocaliva tablets, it added.

The product will be manufactured at the company's Nagpur-based manufacturing facility, Lupin said.

As per IQVIA MAT March 2023 sales data, Obeticholic Acid tablets had estimated annual sales of $262 million in the U.S.

Shares of Lupin ended 0.11% at Rs 804.55 apiece on the BSE.