Pharma major Lupin Ltd. said its US subsidiary Lupin Pharmaceuticals, Inc.(LPI), has been granted final approval by the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) to market generic version of UCB's Keppra tablets. Commercial shipment of the product has commenced.
Lupin's Levetiracetam 500 mg and 750 mg extended release tablets are the AB-rated generic equivalent of Keppra, an anti-epileptic drug indicated for adjunctive therapy in the treatment of partial onset seizures in patients less than 16 years of age with epilepsy. Keppra tablets had annual sales of approximately $161 million for the 12 months ended June 2011 based on IMS Health sales data.
Lupin is an innovation led transnational pharmaceutical company producing a wide range of quality, affordable generic and branded formulations and APIs.