Mylan Inc announced that its subsidiary Mylan Pharmaceuticals Inc received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Levetiracetam tablets, 250 mg, 500 mg and 750 mg. Levetiracetam Tablets are the generic version of UCB Pharma's Keppra.
Robert J Coury, Mylan's vice chairman and CEO, 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 Societe Anonyme and UCB Pharma Inc (collectively, UCB) previously had entered into an agreement to settle pending litigation relating to Levetiracetam Tablets. Pursuant to the settlement, Mylan was given the right to market the 250 mg, 500 mg and 750 mg strengths of Levetiracetam Tablets in the United States as early as Nov. 1, 2008, provided that UCB obtained paediatric exclusivity for Keppra and Mylan's ANDA obtained final approval from the FDA. UCB was granted paediatric exclusivity relating to the '639 patent, which extends to Jan. 14, 2009. Additional terms of the settlement are confidential.
Mylan Inc., which provides products to customers in more than 140 countries and territories, ranks among the leading diversified generic and specialty pharmaceutical companies in the world.