Lupin Gets USFDA Nod For Generic Seizure Drug

Lupin Ltd. said it has received tentative approval from the US Food and Drug Administration for its abbreviated new drug application for Oxcarbazepine extended-release tablets in 150 mg, 300 mg, and 600 mg strengths. The drug will be manufactured at Lupin’s Nagpur facility.

The tablets are bioequivalent to Supernus Pharmaceuticals’ Oxtellar XR and are indicated for treating partial-onset seizures in patients aged six and above. Citing IQVIA data, Lupin said the drug saw annual US sales of around $206 million for the year ended April.