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Dec 28, 2011

FDA Approves Mylan’s First-to-File ANDAs for Hypertension, Epilepsy Drugs

  • FDA approved Mylan’s generic eprosartan mesylate tablets (400 mg and 600 m) and also the firm’s levetiracetam extended-release (ER) tablets (500 mg and 750 mg). Both FDA clearances relate to first-to-file ANDA submissions for their respective drugs.

    The eprosartan approval covers a generic version of Abbott’s hypertension drug Teveten®. The levetiracetam sanction covers a generic version of UCB's Keppra XR® Tablets, which is used to treat partial onset seizures in epilepsy patients over 16 years of age. 

    Mylan says estimates indicate that U.S. sales of eprosartan mesylate tablets, 400 mg and 600 mg, reached some $4.9 million in the 12 months ending September 30, 2011, and U.S. sales of levetiracetam ER were approximately $162.8 million during the same period.

    The firm has an additional 170 ANDAs pending FDA approval, representing products with $98.4 billion in annual sales. Forty two of these ANDAs are potential first-to-file submissions, representing branded product sales of some $26.8 million.

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