PITTSBURGH, March 20, 2012 /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 Ibandronate Sodium Tablets, 150mg. This product is the generic version of Roche's Boniva®, which is indicated for the treatment and prevention of osteoporosis in postmenopausal women.
Boniva® had U.S. sales of approximately $517 million for the 12 months ending Dec. 31, 2011, according to IMS Health. Mylan is shipping the product immediately.
Currently, Mylan has 173 ANDAs pending FDA approval representing $100.9 billion in annual sales, according to IMS Health. Forty-two of these pending ANDAs are potential first-to-file opportunities, representing $27.4 billion in annual brand sales, for the 12 months ending December 31, 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.
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