Lupin receives tentative approval from U.S. FDA for Obeticholic Acid Tablets

Global pharma major Lupin Limited (Lupin) today 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).

Lupin shares

The shares of Lupin on Thursday closed at Rs 648.80, down by 1.53 per cent.