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