Lupin has 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) for Oxcarbazepine Extended-Release (ER) Tablets in strengths of 150 mg, 300 mg, and 600 mg.
The tablets are bioequivalent to Oxtellar XR ER Tablets of the same strengths, developed by Supernus Pharmaceuticals, Inc. The approved product is indicated for the treatment of partial-onset seizures in patients aged six years and older.
Lupin stated that the approved product will be manufactured at its facility in Nagpur, India.
According to IQVIA MAT data from April 2025, Oxcarbazepine ER Tablets (Reference Listed Drug: Oxtellar XR) recorded estimated annual sales of USD 206 million in the United States.