USFDA approves Sun Pharma's generic Keppra Injection ANDA

Sun Pharma announced that USFDA 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 sales 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 reach the market shortly with this product.