Lupin gets tentative US FDA nod for anti-epilepsy drug

Pharma major Lupin ’s US subsidiary has got tentative approval from US Food and Drugs Administration (FDA) for its abbreviated new drug application (ANDA) to market Pregabalin Capsules, used for treating pain caused by neurologic diseases and seizures.

Lupin Pharmaceuticals Inc’s drug is the generic equivalent of Lyrica capsules made by CP Pharmaceuticals, a unit of Pfizer.

Lyrica had sales of about USD 1.7 billion in the US market in the year ended March 2011, Lupin said citing IMS Health sales data.

Lupin shares were up 2.6% at Rs 461.75 on NSE post the announcement in afternoon trade.