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“Press Release » Octapharma Receives Orphan Drug Exclusivity Approval for wilate (R) - A Replacement Therapy Developed Specifically for von Willebrand Disease Octapharma AG, one of the largest manufacturers of plasma products in the world, today announced that it has received orphan drug exclusivity approval for wilate® for the treatment of spontaneous or trauma-induced bleeding episodes in patients with severe von Willebrand disease (VWD) as well as in patients with mild or moderate VWD in whom the use of desmopressin is known or suspected to be ineffective or contraindicated.”
“The FDA's approval and granting of orphan drug exclusivity of wilate® marks the entrance of Octapharma USA into the U.S. blood coagulation market, with product availability scheduled for early 2010.”
“In addition, the ion-exchange chromatography step utilized during wilate® manufacturing contributes to the viral safety.”
“There is a possibility that wilate® can cause hypersensitivity or allergic reactions.”
“The wilate® manufacturing process provides two independent and effective virus inactivation procedures, namely S/D treatment in bulk and TDH treatment of the lyophilized product in final container.”
“The most common related Adverse Reactions observed during the wilate® clinical studies include: urticaria and dizziness.”
“The FDA orphan drug exclusivity approval for wilate® is an important aspect in Octapharma ` s development of this drug," said Kim Bjornstrup, Vice Chairman Octapharma Group.”
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“FDA grants orphan drug exclusivity approval for Octapharma AG's wilate”
“FDA grants orphan drug exclusivity approval for Octapharma AG's wilate >”
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