Mylan receives final FDA approval for Levetiracetam ER Tablets ANDA

Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Levetiracetam Extended-release (ER) Tablets, 500 mg and 750 mg. This product is the generic version of UCB's Keppra XR® Tablets, which are a treatment for partial onset seizures in patients over 16 years of age with epilepsy. 

Levetiracetam ER Tablets had U.S. sales of approximately $162.8 million for the 12 months ending Sept. 30, 2011, according to IMS Health. Mylan is shipping this product immediately.

Currently, Mylan has 170 ANDAs pending FDA approval representing $98.4 billion in annual sales, according to IMS Health. Forty-two of these pending ANDAs are potential first-to-file opportunities, representing $26.8 billion in annual brand sales, for the 12 months ending June 30, 2011, according to IMS Health.