FDA Approves Generic Version of Keppra XR

Lupin Pharmaceuticals Inc. Sept. 14 announced that the Food and Drug Administration has approved the company’s abbreviated new drug application to market a generic version of UCB’s Keppra XR (levetiracetam extended-release) tablets.

Keppra XR is an antiepileptic drug indicated for use in combination with a primary treatment for partial onset seizures in patients at least 16 years old with epilepsy, the Baltimore-based company said.

Lupin Pharmaceuticals said it has begun commercial shipment of the product. Lupin Pharmaceuticals is the U.S. wholly owned subsidiary of India-based Lupin Limited. UCB recently settled litigation with another generic maker, Par Pharmaceutical Inc., over Keppra ...