Lupin gets USFDA nod for Oxcarbazepine ER tablets

Lupin announced that it has received tentative approval from the U.S Food and Drug Administration (US FDA) for its abbreviated new drug application for Oxcarbazepine extended-release (ER) tablets.

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.

This product would be manufactured at Lupins Nagpur facility in India.

Oxcarbazepine ER tablets (RLD Oxtellar XR) had estimated annual sales of $206 million in the U.S. (IQVIA MAT April 2025).

Lupin is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. It specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.

The companys consolidated net profit surged 114.9% to Rs 772.52 crore on 13.6% jump in net sales to Rs 5,562.20 crore in Q4 FY25 over Q4 FY24.

The scrip rose 0.20% to end at Rs 1,999.20 on the BSE.

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