Lupin bags tentative nod from USFDA for partial-onset seizures drug Oxcarbazepine ER
Mumbai: Lupin Limited 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, 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 partial-onset 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).
The latest development adds to Lupin’s growing portfolio of generic neurology drugs in the U.S. market.
In May, the company launched Eslicarbazepine Acetate Tablets, 200 mg, 400 mg, 600 mg, and 800 mg, following the approval from the U.S. FDA.
Read also: Lupin unveils partial onset seizures drug Eslicarbazepine Acetate in US
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