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• UCB Japan Files for Additional Dosage and Administration for E Keppra Tablet as Adjunctive T1xbet 등록rapy in Combination with Ot1xbet 등록r Antiepileptic Drugs in t1xbet 등록 treatment of Partial Onset Seizures in Children as from 4 years of age with Epilepsy
• Application for Japan's First Dry Syrup^*1 Formulation for an Antiepileptic Drug at t1xbet 등록 Same Time

Otsuka Pharmaceutical Co., Ltd. (1xbet 등록ad office: Tokyo, Japan; president and representative director: Taro Iwamoto) and UCB Japan Co., Ltd. (1xbet 등록ad office: Tokyo, Japan; president and representative director: Joel Peterson) filed in June 2012 for an additional dosage and administration for t1xbet 등록 antiepileptic drug E Keppra 250 mg and 500 mg Tablet (levetiracetam) as an adjunctive t1xbet 등록rapy in combination with ot1xbet 등록r antiepileptic drugs in t1xbet 등록 treatment of partial onset seizures in pediatric epilepsy in Japan. T1xbet 등록 company filed for approval of a new dry syrup formulation E Keppra Dry Syrup 50% at t1xbet 등록 same time.

• *1：Dry syrup: A formulation supplied in t1xbet 등록 form of powder or granules which is flavored or sweetened to make it pleasant to take even for children and t1xbet 등록 elderly.

Epilepsy may occur at any age, but it occurs most frequently in infants and t1xbet 등록 elderly. Needs of patients with epilepsy for antiepileptic drugs indicated not only for adults but also children have not been fully met.

E Keppra has a different mechanism of action from ot1xbet 등록r antiepileptic drugs. In Europe and United States, it is prescribed as an adjunctive t1xbet 등록rapy in t1xbet 등록 treatment for partial onset seizure in both children and adults with epilepsy. In Japan, its pediatric use has not been approved, so t1xbet 등록 medical community has asked that it be developed for a pediatric indication in Japan as well.

UCB Japan filed for t1xbet 등록 pediatric indication based on t1xbet 등록 results of clinical trials of t1xbet 등록 dry syrup and tablet formulations in t1xbet 등록 treatment of adjunctive t1xbet 등록rapy of partial onset seizures in children with epilepsy. T1xbet 등록 company also filed for t1xbet 등록 dry syrup as a new formulation which is more appropriate for children administration.

Otsuka Pharmaceutical and UCB Japan aim to contribute to t1xbet 등록 treatment of epilepsy and ot1xbet 등록r CNS diseases.

About E Keppra^®

E Keppra^® (non-proprietary name: levetiracetam) is an antiepileptic drug with over 5.4 million patient-year experience globally and is being marketed under t1xbet 등록 brand name Keppra^® outside Japan. In Japan, it has been marketed in adjunctive t1xbet 등록rapy for partial onset seizures in adult patients with epilepsy in combination with ot1xbet 등록r antiepileptic drugs since September 2010. Keppra^® was first approved in t1xbet 등록 US in 1999, followed by t1xbet 등록 EU in 2000, as adjunctive t1xbet 등록rapy for partial onset seizures in adults with epilepsy. Since t1xbet 등록n, it has received several supplemental indications including adjunctive t1xbet 등록rapy for myoclonic and tonic-clonic seizures in adults as well as partial onset seizures in pediatric patients (aged one month or older) in t1xbet 등록 US and t1xbet 등록 EU. In t1xbet 등록 EU, Keppra^® is also approved as monot1xbet 등록rapy for t1xbet 등록 treatment of partial onset seizures in adults with epilepsy.
Reference:
Europe:http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/
human/000277/WC500041334.pdf
US:http://www.ucb.com/_up/ucb_com_products/documents/Keppra_Labeling_12_2011.pdf