FDA approves Mylan Pharmaceuticals' ANDA for Levetiracetam Tablets

Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Levetiracetam Tablets, 1000 mg. Levetiracetam Tablets are the generic version of UCB Pharma's antiepileptic Keppra®. This additional strength of Levetiracetam Tablets complements Mylan's already approved and marketed strengths of 250 mg, 500 mg and 750 mg.

Levetiracetam Tablets, 1000 mg had U.S. sales of approximately $136 million for the 12 months ending Sept. 30 and is shipping immediately.

Currently, Mylan has 130 ANDAs pending U.S. Food and Drug Administration approval representing $85 billion in annual brand sales, according to IMS. Thirty-seven of these pending ANDAs are potential first-to-file opportunities, representing $19.2 billion in annual brand sales, according to IMS.