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Octapharma Aims to Expand U.S. Immune Globulin Therapy Portfolio
Date:9/23/2009

LACHEN, SWITZERLAND and HOBOKEN, N.J., Sept. 23 /PRNewswire/ -- Octapharma AG recently submitted its Biological License Application for octagam(R) 10% (human normal intravenous immunoglobulin, liquid) to the U.S. Food and Drug Administration (FDA) with the goal of expanding the biopharmaceutical company's U.S. immune globulin therapy portfolio by early 2010. The application was submitted for the treatment of Idiopathic Thrombocytopenic Purpura (ITP), a blood-clotting disorder that can result in excessive bruising and bleeding.

"We are extremely pleased with the BLA submission for octagam 10% and look forward to advancing Octapharma's firm commitment to providing immune globulin therapy in the U.S. marketplace," said Octapharma USA President Flemming Nielsen. "The expected introduction of octagam 10% will provide yet another immune globulin intravenous (IGIV) product option for patients that further builds on the success already achieved with the octagam product line both globally and in the U.S."

In 2004, Octapharma, one of the largest plasma products manufacturers in the world, gained U.S. approval from the FDA for its IGIV product, octagam(R) (immune globulin intravenous [human] 5%). The therapy, which treats disorders of the immune system, has
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