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The USFDA has provided its final approval to Aurobindo Pharma for its Lacosamide tablets that are used in the treatment of partial-onset seizures in American market.
Aurobindo Pharma has said in a BSE filing that “The company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Lacosamide tablets, 50 mg, 100 mg, 150 mg and 200 mg.”
It added that the company is eligible for 180 days of generic drug shared exclusivity.
Aurobindo has said that the launch of this product will be based on the outcome of the litigation in the US Court with UCB.
“The approved product has an estimated market size of USD 782 million for the twelve months ending February 2016 according to IMS,” it said.
