Product Approval Information
Proper Name: Antihemophilic Factor/von Willebrand Factor Complex (Human)
Tradename: Alphanate
Manufacturer: Grifols Biologicals Inc, License #1694
Package Insert (PDF - 1.1 MB) - January, 2007
Date: January 31, 2007
Indication: For surgical and/or invasive procedures in patients with von Willebrand Disease (VWD) in whom desmopressin (DDAVP) is either ineffective or contraindicated. It is not indicated for patients with severe VWD (Type 3) undergoing major surgery.
January 31, 2007 Approval Letter
Press Release: FDA Approves New Product to Treat Von Willebrand Disease