Lupin receives USFDA tentative approval for Obeticholic Acid Tablets

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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