Sun Pharma announced that US FDA has granted an approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Keppra injection, levetiracetam injection.
This generic levetiracetam injection, 100 mg/ml packaged in 500 mg/5 ml single use vials, is equivalent to UCB’s Keppra injection 100 mg/ml. Annual sale in US for levetiracetam injection is estimated at $ 85 million.
Levetiracetam injection is indicated as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy. It is also indicated as adjunctive therapy in the treatment of myoclonic seizures in patients with Juvenile myoclonic epilepsy. This injection is an alternative for patients when oral administration is temporarily not feasible.