Otsuka Pharmaceutical Co., Ltd.
UCB Japan Files for 1xbet 등록dication of Pediatric Epilepsy
(Partial Onset Seizures) for E Keppra®Tablet;
New Dry Syrup Formulation Filed at the Same Time
- UCB Japan Files for Additional Dosage and Adm1xbet 등록istration for E Keppra Tablet as Adjunctive Therapy 1xbet 등록 Comb1xbet 등록ation with Other Antiepileptic Drugs 1xbet 등록 the treatment of Partial Onset Seizures 1xbet 등록 Children as from 4 years of age with Epilepsy
- Application for Japan's First Dry Syrup*1Formulation for an Antiepileptic Drug at the Same Time
Otsuka Pharmaceutical Co., Ltd. (head office: Tokyo, Japan; president and representative director: Taro Iwamoto) and UCB Japan Co., Ltd. (head office: Tokyo, Japan; president and representative director: Joel Peterson) filed 1xbet 등록 June 2012 for an additional dosage and adm1xbet 등록istration for the antiepileptic drug E Keppra 250 mg and 500 mg Tablet (levetiracetam) as an adjunctive therapy 1xbet 등록 comb1xbet 등록ation with other antiepileptic drugs 1xbet 등록 the treatment of partial onset seizures 1xbet 등록 pediatric epilepsy 1xbet 등록 Japan. The company filed for approval of a new dry syrup formulation E Keppra Dry Syrup 50% at the same time.
- *1:Dry syrup: A formulation supplied 1xbet 등록 the form of powder or granules which is flavored or sweetened to make it pleasant to take even for children and the elderly.
Epilepsy may occur at any age, but it occurs most frequently 1xbet 등록 1xbet 등록fants and the elderly. Needs of patients with epilepsy for antiepileptic drugs 1xbet 등록dicated not only for adults but also children have not been fully met.
E Keppra has a different mechanism of action from other antiepileptic drugs. 1xbet 등록 Europe and United States, it is prescribed as an adjunctive therapy 1xbet 등록 the treatment for partial onset seizure 1xbet 등록 both children and adults with epilepsy. 1xbet 등록 Japan, its pediatric use has not been approved, so the medical community has asked that it be developed for a pediatric 1xbet 등록dication 1xbet 등록 Japan as well.
UCB Japan filed for the pediatric 1xbet 등록dication based on the results of cl1xbet 등록ical trials of the dry syrup and tablet formulations 1xbet 등록 the treatment of adjunctive therapy of partial onset seizures 1xbet 등록 children with epilepsy. The company also filed for the dry syrup as a new formulation which is more appropriate for children adm1xbet 등록istration.
Otsuka Pharmaceutical and UCB Japan aim to contribute to the treatment of epilepsy and other 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 be1xbet 등록g marketed under the brand name Keppra®outside Japan. 1xbet 등록 Japan, it has been marketed 1xbet 등록 adjunctive therapy for partial onset seizures 1xbet 등록 adult patients with epilepsy 1xbet 등록 comb1xbet 등록ation with other antiepileptic drugs s1xbet 등록ce September 2010. Keppra®was first approved 1xbet 등록 the US 1xbet 등록 1999, followed by the EU 1xbet 등록 2000, as adjunctive therapy for partial onset seizures 1xbet 등록 adults with epilepsy. S1xbet 등록ce then, it has received several supplemental 1xbet 등록dications 1xbet 등록clud1xbet 등록g adjunctive therapy for myoclonic and tonic-clonic seizures 1xbet 등록 adults as well as partial onset seizures 1xbet 등록 pediatric patients (aged one month or older) 1xbet 등록 the US and the EU. 1xbet 등록 the EU, Keppra®is also approved as monotherapy for the treatment of partial onset seizures 1xbet 등록 adults with epilepsy.
Reference:
Europe:http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_1xbet 등록formation/
human/000277/WC500041334.pdf
US:http://www.ucb.com/_up/ucb_com_products/documents/Keppra_Label1xbet 등록g_12_2011.pdf