Mylan Inc., one of the leading generic and specialty pharmaceutical companies in the world, reported that its subsidiary Mylan Pharmaceuticals Inc. 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. 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 US sales of approximately $162.8 million for the 12 months ending September 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.