Generic Keppra injection approved for marketing in U.S.

posted on:
June 21, 2010

author:
JENNIFER WALKER-JOURNEY

Sun Pharma has received approval from the Food and Drug Administration (FDA) to market a generic version of the anti-seizure medication Keppra. The generic Keppra comes in 100 mg/ml  packaged in 500 mg/5 ml single use vials and are meant to serve as a generic equivalent to UCB’s Keppra Injection 100mg/ml. The generic levetiracetam’s annual sales in the U.S. is estimated at $85 million.

Levetiracetam injection is indicated as adjunctive therapy in the treatment or partial onset seizures in adults with epilepsy. It also indicated as adjunctive therapy in the treatment of myoclonic seizures in patients with Juvenile myoclonic epilepsy.

Brand-name Keppra is made by UCB. Beginning in 2009, the FDA approved generic versions of Keppra for marketing in the U.S. Generic drugs must undergo certain tests to  determine if the active ingredient in the generics are equivalent to the brand-name medications. However, generics often contain different inactive ingredients, such as fillers and dyes.

Since generic Keppra was introduced to the market, many people whose seizures were managed under the brand-name Keppra reported suffering from seizures and other adverse effects after switching to a generic version.

Sun Pharma expects to launch its generic Keppra injection in the near future. 

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