Sun Pharma's epilepsy drug granted US FDA approval
17 Jun 2010
Mumbai: Sun Pharma has said that its had been granted marketing approval by the US FDA for its abbreviated new drug application (ANDA) to market a generic version of Keppra Injection, the injectible version of levetiracetam.
This generic levetiracetam injection, 100 mg/ml packaged in 500 mg / 5 ml single use vials, is equivalent to Belgian biopahrma maker 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.
The company expects to introduce the product shortly.