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
Earlier, in July, Lupin secured USFDA approval for its ANDA for Topiramate Extended-Release Capsules, 25 mg, 50 mg, 100 mg, and 200 mg, a generic equivalent of Trokendi XR Extended-Release Capsules, 25 mg, 50 mg, 100 mg, and 200 mg, of Supernus Pharmaceuticals, Inc.
Read also: Lupin gets USFDA nod for Topiramate Extended Release Capsules for seizures
Lupin Limited is a global pharmaceutical company headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. The company has a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally.
Read also: Lupin to present data from Phase 1a trial evaluating LNP7457 at ASCO annual meeting
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