The US Food & Drug Administration (USFDA) has granted tentative approval to the company for its Abbreviated New Drug Application (ANDA) for Lacosamide tablets in the strengths of 50 mg, 100 mg, 150 mg and 200 mg, Aurobindo Pharma said in a statement today.
This ANDA is at present under litigation in the United States District Court for the District of Delaware, Aurobindo Pharma said.
The product is generic equivalent of USB Inc's Vimpat tablets and is used in the treatment of partial-onset seizures in patients with epilepsy aged 17 years and older, Aurobindo Pharma said.
Shares of Aurobindo Pharma today closed at Rs 1,225.95 per scrip on BSE, down 1.32 per cent from its previous close.
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