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).

Shares of Lupin Limited was last trading in BSE at Rs. 648.50 as compared to the previous close of Rs. 659.35. The total number of shares traded during the day was 38926 in over 2756 trades.

The stock hit an intraday high of Rs. 665.65 and intraday low of 646.75. The net turnover during the day was Rs. 25504466.00.

Source : Equity Bulls

Keywords

Lupin INE326A01037 TentativeApproval USFDA ANDA ObeticholicAcidTablets