Biologicals Approved In 1999
Executive Summary
Product.......... Humate-P (S, V) Ingredient....... Antihemophilic factor/von Willebrand factor complex (human) Sponsor.......... Centeon Pharma GmbH Indication....... New indication for treatment of spontaneous and trauma-induced bleeding episodes in severe von Willebrand disease and in mild and moderate von Willebrand disease where use of desmopressin is known or suspected to be inadequate Date Approved.... 4/1/1999 Application No... 96-1099 Footnote......... Standard review; Orphan drug