Lupin announced that it has received preliminary 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, to market a generic equivalent of Intercept Pharmaceuticals, Inc.’s Ocaliva Tablets, 5 mg and 10 mg. In the United States, Obeticholic Acid Tablets (RLD Ocaliva) had an estimated annual sales of USD 255 million (IQVIA MAT December 2022).
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