Lupin receives tentative approval from U.S. FDA for Oxcarbazepine ER 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 for Oxcarbazepine Extended-Release (ER) Tablets, 150 mg, 300 mg, and 600 mg. This product would be manufactured at Lupin's Nagpur facility in India.

Oxcarbazepine ER Tablets, 150 mg, 300 mg, and 600 mg are bioequivalent to Oxtellar XR® ER Tablets, 150 mg, 300 mg, and 600 mg, of Supernus Pharmaceuticals, Inc., and are indicated for the treatment of partialonset seizures in patients 6 years of age and older.

Oxcarbazepine ER Tablets (RLD Oxtellar XR®) had estimated annual sales of USD 206 million in the U.S. (IQVIA MAT April 2025).

Shares of Lupin Limited was last trading in BSE at Rs. 1999.20 as compared to the previous close of Rs. 1995.30. The total number of shares traded during the day was 50186 in over 3445 trades.

The stock hit an intraday high of Rs. 2007.55 and intraday low of 1985.25. The net turnover during the day was Rs. 100382263.00.

Source : Equity Bulls

Keywords

Lupin INE326A01037 Pharmaceuticals USFDA TentativeApproval ANDA OxcarbazepineERTablets