Octapharma USA Feb. 27 announced that it has submitted a biologics license application for OctaplasLG to the Food and Drug Administration with the goal of expanding its U.S. product portfolio in the fourth quarter of 2012.
The Hoboken, N.J.-based company said it is seeking approval of the drug for managing preoperative or bleeding patients who require replacement of multiple plasma coagulation factors.
The application also seeks to gain marketing approval for the substitution of intentionally removed plasma, such as plasma exchange in patients with thrombotic thrombocytopenic purpura, a blood disorder that causes clot formation in small blood vessels, Octapharma said. ...
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