Mylan gets final OK for Keppra generic

Mylan Pharmaceuticals has received final approval from the US Food and Drug Administration for its Abbreviated New Drug Application for levetiracetam tablets, 250mg, 500mg and 750mg. The product is a generic version of Belgian group UCB Pharma's Keppra.

Robert Coury, Mylan's chief executive, commented: "we are extremely pleased to be able to monetize another first-to-file opportunity and to offer a more affordable alternative for patients. In addition, after our very strong performance in the third quarter, the launch of levetiracetam is another significant step toward the continued execution on our stated goals for 2009 and beyond."

Mylan and UCB previously had entered into an agreement to settle pending litigation relating to levetiracetam. Pursuant to this, Mylan was given the right to market the three strengths of the drug in the USA as early as November 1, provided that UCB obtained pediatric exclusivity for Keppra and Mylan's ANDA gained final approval from the FDA. UCB was granted pediatric exclusivity relating to the '639 patent, which extends to January 14, 2009. Additional terms of the settlement are confidential.