Qualitest Pharmaceuticals Wins The US FDA Approval of Qualitest Levetiracetam ANDA

Qualitest Pharmaceuticals, a generic pharmaceutical company, has won the US Food and Drug Administration (FDA) approval for abbreviated new drug application (ANDA) for Levetiracetam extended-release tablets, 500mg and 750mg.

The Levetiracetam extended-release tablets, 500mg and 750mg, are the generic equivalent of UCB's Keppra XR.

As per IMS Health, the total combined sales in the US for the 12 months ending 31 May 2012 for Levetiracetam extended-release tablets, 500mg and 750mg, were approximately $124.8m.

In Europe, Keppra is indicated for intravenous administration and is available as 100mg/mL concentrate for solution for infusion while in the US it is available as an intravenous formulation for the adjunctive treatment in adults (= 16 years of age) with the following seizure types when oral administration of Keppra is temporarily not feasible partial onset seizures, myoclonic seizures in patients with juvenile myoclonic epilepsy and primary generalised tonic-clonic seizures.