Lupin announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) 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 USD 255 million in the U.S. (IQVIA MAT December 2022).
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