Lupin bags tentative nod from USFDA for partial-onset seizures drug Oxcarbazepine ER
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2025-06-07 11:54 GMT | Update On 2025-06-07 11:54 GMT
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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.
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