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Keppra XR(TM) Extended-Release Tablets Filed with the FDA
Date:1/16/2008

n partial onset seizures and 8.9% were free from any type of seizure over the treatment period, compared to 2.5% and 1.3% in the placebo group, respectively.

The study also found that extended-release levetiracetam tablets were generally well tolerated. The most common reported adverse events that occurred more frequently in the extended-release levetiracetam group were somnolence, influenza, nausea, nasopharyngitis, irritability, and dizziness.

About Epilepsy: Epilepsy is a chronic neurological disorder affecting 40 million people worldwide including 2.5 million people in the U.S. It is caused by abnormal, excessive electrical discharges of the nerve cells or neurons in the brain. Epilepsy is characterized by a tendency to have recurrent seizures and defined by two or more unprovoked seizures. There are many different seizure types and epileptic syndromes, and effective classification guides treatment and prognosis. Between 70-80% of individuals are successfully treated with one of the more than 20 antiepileptic drugs now available. However, 20-30% of patients have either intractable or uncontrolled seizures or significant adverse side effects secondary to medication highlighting the ongoing need for the development of new antiepileptic drugs.

About Keppra(R) in the U.S.: Keppra(R) (levetiracetam) tablets were first approved by the FDA in 1999 as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy. Since 1999, Keppra(R) has received several supplemental indications as adjunctive therapy for epilepsy, making it one of the few treatments approved to treat seizure types that together account for more than 80 percent of all seizures.

Important Safety Information

Keppra(R) tablets and oral solution are indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy, myoclonic seizures in adults and adolescents 12 years of age and
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SOURCE UCB
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