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FDA Approves U.S. Market Return for octagam® Following Octapharma's Implementation of Enhanced Safety Measures
Date:11/4/2011

dent Flemming Nielsen. "Our collaboration with the FDA over the last year has enhanced awareness of the industry-wide concerns regarding procoagulant activity and TEEs. Octapharma has always believed that patient safety comes first so the octagam® 5% that we will return to the U.S. market in a few weeks will enjoy the highest level of safety scrutiny available today and the same level of tolerability that our patients have come to expect from Octapharma therapies."

Thromboembolic events occur due to the formation of a clot or thrombus in an artery or vein that breaks loose and is carried by the blood stream to occlude another vessel. Over the last year, the FDA has identified several immune globulin products on the U.S. market that may have suspect levels of procoagulant activity. Multiple industry research initiatives indicate that TEEs can be caused by a number of different biochemical/physiological factors in susceptible individuals. For those TEE cases involving octagam® 5%, however, the root cause was determined to be associated only with activated Factor XI, one of the many coagulation factors involved in the complex clotting cascade.

Octapharma collaborated with the FDA's Center for Biologics Evaluation and Research to develop and validate a scientific method to measure the amount of activated Factor XI, the root cause of the TEEs, both during the manufacturing process and at the finished product stage. Although other procoagulant factors, such as kallikrein, have been linked to TEEs i
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SOURCE Octapharma USA
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