FDA Approves Anticoagulant Octaplex

Octapharma USA Dec. 1 announced that the Food and Drug Administration has approved Octaplex (human prothrombin complex, freeze dried) as a fast track product for the reversal of anticoagulation therapy in patients under vitamin K antagonist therapy with the need for urgent surgery or invasive procedures.

FDA also previously granted orphan drug exclusivity for Octaplex in this indication, the Hoboken, N.J.-based company said. Orphan drug designation is awarded to drugs being developed to treat rare diseases affecting fewer than 200,000 people in the United States.

Octapharma USA is a subsidiary of Lachen, Switzerland-based Octapharma AG.