Octapharma USA recently announced that the US Food and Drug Administration (FDA) has approved revised product labeling for WILATE®, the company’s human plasma-derived von Willebrand factor/factor VIII product. The new labeling is for the prevention of excessive bleeding during and after minor and major surgery in both adult and pediatric patients with von Willebrand disease (VWD).
The revised labeling expands the FDA license for WILATE®. It previously included only the treatment of spontaneous and trauma-induced bleeding episodes in patients with severe VWD, as well as patients with mild or moderate VWD in whom the use of desmopressin is known or suspected to be ineffective or contraindicated.
“Preventing excessive intra- and post-operative bleeding in pediatric and adult VWD patients is a continuing challenge,” said Octapharma USA President Flemming Nielsen. “We are extremely pleased that WILATE® is now available for medical providers managing this important issue. Octapharma is committed to providing lifesaving and enhancing therapeutic options for the bleeding disorders community.”
Source: Octapharma news release dated August 13, 2015
