FDA approves Mylan's Tranexamic Acid Injection ANDA

Dec 3 2011

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.