Lupin has received tentative approval from the United States Food and Drug Administration (USFDA) 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 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 $206 million in the U.S. (IQVIA MAT April 2025).
Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.
