Casey Kristin Frye
Dec 2, 2011
Mylan's drug approved by the FDA
Mylan announced today The FDA has granted final approval for its Abbreviated New Drug Application for Tranexamic Acid Injection. This generic version of Pharmacia & Upjohn's Cyklokapron® Injection is intended for patients with hemophilia to prevent or reduce hemorrhaging during oral surgery. According to IMS Health, Tranexamic Acid Injection has had sales in the U.S. of around $17 million dollars in 12 months. There are currently 165 other Abbreviated New Drug Applications pending approval from Mylan with $99.4 billion represented in annual sales. Mylan is to ship Tranexamic Acid Injection immediately.
SOURCE: Mylan Press Release
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