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."
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