Lupin gets final US FDA nod for generic anti-epileptic drug

MUMBAI: Pharma major, Lupin Ltd announced today that its subsidiary, Lupin Pharmaceuticals Inc has received final approval from US Food and Drugs Administration ( FDA) for its abbreviated new drug application to market a generic version of anti-epilepsy drug Levetiracetam extended release tablets.

Lupin's Levetiracetam is a generic version of UCB Group's Keppra XR tablets.

Commercial shipments of the product has now commenced, Lupin said in a statement here.

Lupin's Levetiracetam 500 mg and 750 mg extended release tablets are the AB-rated generic equivalent of Keppra XR, an antiepileptic drug indicated for adjunctive therapy in the treatment of partial onset seizures in patients of 16 years of age with epilepsy, it said.

The annual sale of Keppra XR tablets are estimated at USD 161 million for the twelve months ended June 2011 based on IMS Health sales data.

Lupin is engaged in producing a wide range of quality, affordable generic and branded formulations and APIs. The company has significant market share in cardiovasculars, diabetology, asthma, pediatrics and anti-infectives in addition holding global leadership positions in the anti-TB and cephalosporins space.

Today, Lupin is the 5th largest generics player in the US (by prescriptions), the only Asian company to achieve that distinction. The company is also the fastest growing top 10 pharmaceutical player in India, Japan and South Africa, the release said.