Mylan Receives Approval for First-to-File Generic Keppra XR Extended-Release Tablets
Company shares first-to-file marketing exclusivity on all strengths
PITTSBURGH, Dec. 27, 2011 /PRNewswire/ -- 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.
Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 150 countries and territories. The company maintains one of the industry's broadest and highest quality product portfolios supported by a robust product pipeline; operates one of the world's largest active pharmaceutical ingredient manufacturers; and runs a specialty business focused on respiratory, allergy and psychiatric therapies. For more information about Mylan, please visit www.mylan.com. For more information about generic drugs, please visit www.ChoosingGenerics.com.
SOURCE Mylan Inc.
CONTACT: Nina Devlin (Media), +1-724-514-1968, or Kris King (Investors), +1-724-514-1813
Web Site: http://www.mylan.com
Posted: December 2011