Synthon obtains European approvals for two Levetiracetam products
Nijmegen, July 5, 2011 - 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.