Lupin Gets USFDA Nod For Generic Seizure Drug
Global pharma major Lupin Limited (Lupin) today announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Brivaracetam Tablets, 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg, a generic equivalent of Briviact Tablets, 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg, of UCB Inc.
The product will be manufactured at Lupin’s facility in Nagpur, India. Brivaracetam Tablets, 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg, (RLD Briviact) had estimated annual sales of USD 420 million in the U.S. (IQVIA MAT September 2022).
Brivaracetam Tablets are used to treat or control the partial onset of seizures in adults, young children and infants. The company's stock rallied by 3.47 per cent to close at 750 a piece on Wednesday.
