IV Busulfex™ Receives Orphan Designation In Australia
November 3rd, 2005 Melbourne, Australia.
Orphan Australia Pty Ltd announced that its application for orphan drug designation of IV Busulfex (intravenous busulfan) was approved on 12 October 2005 by the Therapeutic Goods Administration (TGA) in Australia.
IV Busulfex received orphan designation for use in combination with other chemotherapeutic agents and/or radiotherapy as a conditioning regimen prior to haematopoietic progenitor cell transplantation.
The orphan drug designation represents a significant regulatory step for the treatment of patients that require haematopoietic progenitor cell transplantation.
IV Busulfex is an intravenous form of the oral busulfan and allows for precise dosing and elimination of problems associated with oral administration of busulfan in the haematopoietic progenitor cell transplantation setting. IV Busulfex is currently approved for marketing in 36 countries, including the United States, Canada and countries in the European Union and Asia .
Orphan Australia is a privately owned pharmaceutical company based in Melbourne, providing niche products to Australia, New Zealand and selected South East Asian countries. Orphan Australia specialises in the development, marketing and distribution of products typically used by specialists to treat serious and/or life threatening disorders.
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