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news.Mylan Pharmaceuticals has received final approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for Levetiracetam Extended-release (ER) Tablets, 500 mg and 750 mg.
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Levetiracetam, the generic version of UCB’s Keppra XR Tablets, is indicated as a treatment for partial onset seizures in patients over 16 years of age with epilepsy.
Levetiracetam ER Tablets generated sales of around $162.8m in the US for the 12 months ending 30 September 2011, according to data from IMS Health.
Currently, the company has 170 ANDAs pending FDA approval, 42 of which are potential first-to-file opportunities, representin $26.8bn in annual brand sales, for the 12 months ending 30 June 30 2011.