13 August 2015 - Octapharma USA today announced the U.S. Food and Drug Administration (FDA) has approved revised product labeling for Wilate [von Willebrand Factor/Coagulation Factor VIII Complex (Human)] to include prevention of excessive bleeding during and after minor and major surgery in adult and pediatric von Willebrand disease (VWD) patients.VWD is a complex congenital bleeding disorder that affects one to two percent of the general population or approximately 3 million people in the United States.
The newly approved product label expands the FDA license for Wilate, which formerly 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. Octapharma USA is a subsidiary of global human protein products manufacturer Octapharma AG, which develops and manufactures high-purity coagulation factor concentrates for patients with bleeding disorders.
For more details, go to: http://www.wilateusa.com