Lupin shares rise 1.5% as firm gets USFDA nod for generic drug
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The Mumbai-based firm has received a nod from the USFDA for its abbreviated new drug application for Brivaracetam Oral Solution (10 mg/mL)
Drug firm Lupin on Wednesday said it has received approval from the US health regulator to market a generic medication to treat seizures.
The Mumbai-based firm has received a nod from the USFDA for its abbreviated new drug application (ANDA) for Brivaracetam Oral Solution (10 mg/mL), it said in a statement.
Brivaracetam is the bioequivalent to UCB, Inc’s Briviact Oral Solution (10 mg/mL) and is indicated for the treatment of partial-onset seizures in patients.
Following the approval, the company initiated the launch of Brivaracetam Oral Solution in the US, it stated.
“Brivaracetam is the bioequivalent to Briviact® Oral Solution, 10 mg/mL, of UCB, Inc. and is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. Following the approval, the company initiated the launch of Brivaracetam Oral Solution in the United States,” said the firm in a stock exchange filing.
As per industry estimates, Brivaracetam Oral Solution had an estimated annual sale of $135 million in the US.
On February 25, Lupin shares were trading 1.5% higher at Rs 2,284 apiece while the Nifty Pharma index was trading 1.6% higher.
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