The US Food and Drug Administration (FDA) has approved Mylan's Tranexamic acid injection, the generic version of Pharmacia & Upjohn's Cyklokapron injection.
According to a press release from Mylan, its business Mylan Institutional has received final approval from the 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. Tranexamic is indicated for short-term use in patients with haemophilia to reduce or prevent haemorrhage during and following oral surgery.
Tranexamic acid injection had US sales of approximately $17 million for the 12 months ending September 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.