Mylan, a generic pharmaceutical company, has announced that its subsidiary Mylan Pharmaceuticals received final approval from the FDA for its abbreviated new drug application for levetiracetam tablets, 250mg, 500mg and 750mg. Levetiracetam tablets are the generic version of UCB Pharma's Keppra.
Mylan and UCB Societe Anonyme and UCB Pharma have previously entered into an agreement to settle pending litigation relating to levetiracetam tablets.
Pursuant to the settlement, Mylan was given the right to market the 250mg, 500mg and 750mg strengths of levetiracetam tablets in the US, provided that UCB obtained pediatric exclusivity for Keppra and Mylan's abbreviated new drug application obtained final approval from the FDA. UCB was granted pediatric exclusivity relating to the patent, which extends to January 14, 2009.