Lupin gets USFDA’s approval for Obeticholic Acid Tablets

31 May 2023 Evaluate

Lupin has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Obeticholic Acid Tablets, 5 mg and 10 mg, a generic equivalent of Ocaliva Tablets, 5 mg and 10 mg, of Intercept Pharmaceuticals, Inc. This product will be manufactured at Lupin’s Nagpur facility in India. Obeticholic Acid Tablets (RLD Ocaliva) had estimated annual sales of $262 million in the U.S. (IQVIA MAT March 2023).

Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.


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