Aurobindo Pharma has received final approval from the US health regulator for its Lacosamide tablets used for treatment of partial-onset seizures in American market.
“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,” Aurobindo Pharma said in a filing on BSE. The company is eligible for 180 days of generic drug shared exclusivity, it added.
“The launch of this product will be based on the outcome of the litigation in the US Court with UCB,” Aurobindo said. The product is generic version of drug firm UCB Inc’s Vimpat tablets in the same strengths, it added. ”
The approved product has an estimated market size of USD 782 million for the twelve months ending February 2016 according to IMS,” Aurobindo said. The firm has a total of 257 abbreviated new drug application (ANDA) approvals (221 final approvals including 11 from Aurolife Pharma LLC and 36 tentative approvals) from USFDA, it added. Aurobindo Pharma stock was trading at Rs 761.85, down 0.37 percent, on BSE.