Synthon announced today that it has successfully concluded multiple registration procedures for two dosage forms of levetiracetam. Regulatory clearance has been obtained for film coated tablets (250 mg, 500 mg, 750 mg and 1,000 mg) and an oral solution (100 mg/ml) in 17 European countries.
Synthon's products are fully generic and bioequivalent versions of UCB’s Keppra® tablets and oral solution, which are leading epilepsy drugs. European sales of levetiracetam were over 640 million Euros (MAT Dec 2010) based on IMS Midas data. Synthon’s levetiracetam is part of a rich pipeline of research projects and pending regulatory applications.
* Keppra® is a trademark of UCB Pharma S.A.
Synthon, with headquarters in Nijmegen, is a fast-growing pharmaceutical company that started 20 years ago in the laboratories of Radboud University Nijmegen. The company now employs more than 1,300 staff at 11 sites worldwide, and in 2010 it recorded a turnover of EUR 230 million. Synthon is a leader in the field of generic medicines. It has been working in biotechnology since 2007 and is developing rapidly into a ‘specialty pharmaceutical’ company focusing on the therapeutic areas of Multiple Sclerosis and Oncology. For more information, go to www.synthon.com.