Global pharmaceutical company Lupin Limited has secured 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 150 mg, 300 mg, and 600 mg strengths.

The approved product is a generic version of Oxtellar XR®, developed by Supernus Pharmaceuticals, Inc., and is used in the treatment of partial-onset seizures in patients aged six years and older. Lupin’s approved tablets are bioequivalent to the reference listed drug (RLD) Oxtellar XR®.

The medication will be manufactured at Lupin’s Nagpur facility in India, reinforcing the company's robust manufacturing footprint in the global pharmaceutical market.

According to IQVIA MAT data from April 2025, Oxcarbazepine ER Tablets (RLD Oxtellar XR®) recorded estimated annual sales of USD 206 million in the U.S., highlighting a significant market opportunity for Lupin upon final approval and commercialization.

This development underscores Lupin’s continued efforts to expand its portfolio of central nervous system (CNS) therapies in the U.S. market.