Aurobindo Pharma Ltd has received tentative approval from the US Food and Drug Administration (USFDA) for Lacosamide tablets.
They are the generic equivalent of USB Inc’s Vimpat tablets and are used in the treatment of partial-onset seizures in patients with epilepsy aged 17 years and older. The market size for the product is $593 million for the 12 months ended January 2015, according to IMS.
"This Abbreviated New Drug Application contained a Paragraph IV certification and is currently under litigation in the US district court of Delaware,’’ the Hyderabad-based company said in a release.
Aurobindo’s scrip lost 1.32 per cent on the Bombay Stock Exchange and is trading at Rs 1225.95.