HOBOKEN, N.J., Nov. 30, 2011 /PRNewswire/ -- Octapharma USA announced that octagam® [Immune Globulin Intravenous (human) 5% Liquid Preparation] is again available for purchase. The U.S. Food and Drug Administration (FDA) on Nov. 3 approved the U.S. market return of octagam® 5%, a therapy to treat disorders of the immune system.
In August 2010, Octapharma initiated a voluntary market withdrawal of octagam® 5% in the U.S. in response to an observed increase in thromboembolic events (TEEs), which occur when a clot or thrombus forms locally in a blood vessel or breaks loose in the blood stream to occlude another vessel. Octapharma has reported that global sales totaled 1.7 million grams of octagam® 5% and octagam® 10%, [Immune Globulin Intravenous (Human) Liquid Preparation] in the period January 1 through October 30, 2011, an estimated 60,000 treatments, during which there were no reports of TEEs.
"It is a very exciting time for patients throughout the U.S. as they again have access to octagam® 5%, a therapy that has long been valued by the medical comm