Pharma major Lupin on Thursday announced that it has received tentative approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA), Obeticholic Acid Tablets, 5 mg and 10 mg. Obeticholic acid tablets are used treat primary biliary cholangitis.

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Lupin in an exchange filing said, "Company has received tentative U.S. FDA approval for its Abbreviated new Drug Application, Obeticholic Acid Tablets, 5 mg and 10 mg, to market a generic equivalent of Ocaliva Tablets, 5 mg and 10 mg, of Intercept Pharmaceuticals, Inc."

Obeticholic Acid Tablets (RLD Ocaliva) had estimated annual sales of $255 million in the US (IQVIA MAT December 2022).

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Earlier on March 21, 2023, Lupin received US FDA Approval for Brexpiprazole Tablets that is used to treat certain mental/mood disorders.

Headquartered in Mumbai, Lupin develops and commercialises a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

Shares of Lupin closed 1.53 percent lower at Rs 648.80 per share today on National Stock Exchange (NSE).

Also Read: Lupin receives USFDA's nod for Brexpiprazole tablets