Generic Keppra XR®
A seventh product candidate in our generics pipeline is levetiracetam extended release tablets. It is a generic version of the marketed drug Keppra XR®. On February 23, 2016 the U.S. Food and Drug Administration ("FDA") granted final approval of the Company's levetiracetam extended-release tablets for the 500 mg and 750 mg strengths and is available for partnering. The Company's newly approved product is a generic equivalent for the corresponding strengths of the branded product Keppra XR® sold in the United States by UCB, Inc.
Levetiracetam is an antiepileptic drug indicated for the treatment of partial onset seizures in patients with epilepsy. According to Symphony Health Solutions, U.S. sales of levetiracetam extended-release tablets for the 12 months ending December 2016 were approximately $152 million (TRx MBS Dollars).