Lupin Receives USFDA Nod for Seizure Treatment Drug
Mumbai based pharmaceutical major Lupin Ltd on Wednesday announced that it has received approval from the U.S. Food and Drug Administration to market a generic medication used in the treatment of seizures in the United States.The approval covers the company’s Abbreviated New Drug Application for Brivaracetam Oral Solution 10 mg per mL, a key therapy indicated for partial onset seizures in patients.
Bioequivalent to Briviact Oral Solution
Lupin’s Brivaracetam Oral Solution is bioequivalent to Briviact Oral Solution, marketed by UCB, Inc.. The medication is prescribed for the treatment of partial onset seizures, a common form of epilepsy.With the regulatory clearance in place, Lupin has initiated the launch of Brivaracetam Oral Solution in the US market.
Market Opportunity in the US
According to industry estimates, Brivaracetam Oral Solution recorded annual sales of approximately USD 135 million in the United States. The approval enables Lupin to tap into this established market segment within the US generic drug space.Lupin Share Price Movement
Following the announcement, Lupin shares were trading 0.98 percent higher at Rs 2,273.10 apiece on the BSE, reflecting a positive market response to the regulatory milestone.The USFDA approval further strengthens Lupin’s presence in the US generics market, particularly in the neurology segment, as the company expands its portfolio of complex oral formulations.
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