PITTSBURGH, Dec. 2, 2011 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its business Mylan Institutional has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Tranexamic Acid Injection, 100 mg/mL, packaged in 1,000 mg/10 mL Single-dose Vials. This product is the generic version of Pharmacia & Upjohn's Cyklokapron® Injection, which is indicated for short-term use in patients with hemophilia to reduce or prevent hemorrhage during and following oral surgery.
Tranexamic Acid Injection had U.S. sales of approximately $17 million for the 12 months ending Sept. 30, 2011, according to IMS Health. Mylan is shipping this product immediately.
Currently, Mylan has 165 ANDAs pending FDA approval representing $99.4 billion in annual sales, according to IMS Health. Forty-three of these pending ANDAs are potential first-to-file opportunities, representing $26.9 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.|
Copyright©2010 PR Newswire.
All rights reserved