Lupin gets USFDA’s tentative approval for Obeticholic Acid Tablets

23 Mar 2023 Evaluate

Lupin has received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), 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 U.S. (IQVIA MAT December 2022).

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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