Global pharmaceutical company Lupin Limited has announced that it has secured tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Oxcarbazepine Extended-Release (ER) Tablets in 150 mg, 300 mg, and 600 mg strengths. The product will be manufactured at Lupin’s Nagpur facility in India.
Lupin’s Oxcarbazepine ER Tablets are the generic equivalent of Oxtellar XR® ER Tablets (150 mg, 300 mg, and 600 mg) developed by Supernus Pharmaceuticals, Inc. They are indicated for the treatment of partial-onset seizures in patients aged six years and older.
According to IQVIA MAT data from April 2025, the reference product Oxtellar XR® recorded annual U.S. sales of approximately USD 206 million.