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FDA Confirms Orphan Drug Exclusivity Approval for wilate®, Octapharma USA's New Therapy for Common Inherited Bleeding Disorder
Date:8/2/2010

HOBOKEN, N.J., Aug. 2 /PRNewswire/ -- Octapharma USA has received confirmation of orphan drug exclusivity from the U.S. Food and Drug Administration (FDA) for wilate® (von Willebrand Factor/Factor VIII Concentrate, Human), the replacement therapy developed specifically for von Willebrand Disease (VWD). The approval comes from the FDA Office of Orphan Products Development, which helps to advance the development of products that demonstrate promise for the treatment of rare diseases.

"In awarding orphan drug exclusivity, the FDA Office determined that wilate® offers greater viral safety than Humate-P," said

SOURCE Octapharma USA
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