Mumbai-based Sun Pharma Ltd said it received an abbreviated new drug application (ANDA) approval from US Food and Drug Administration (USFDA) to market its levetiracetam injection which is generic version of Keppra injection,.
This levetiracetam injection 100 mg/ml packaged in 500 mg/5ml single use vials is equivalent to UCB's Keppra injection 100 mg/ml. Annual sale in the US for levetiracetam injection is estimated at $85 million, Sun Pharma said in a regulatory filing.
Levetiracetam injection is used in adjunctive therapy for the treatment of partial onset seizures in adults with epilepsy. This injection is an alternative for patients when oral administration is temporarily not feasible.
On Thursday, Sun Pharma shares ended 0.6% down at Rs1,690 on the Bombay Stock Exchange, while the benchmark Sensex closed 0.88% up at 17,616 points.
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