Danish drug developer TopoTarget AS says that its Totect (dexrazone), an agent for the treatment of extravasation resulting from intravenous anthracycline chemotherapy, has been approved by the US Food and Drug Administration. The news follows the resolution of issues raised in an FDA approvable letter that TopoTarget received earlier this year (Marketletter June 4).
The drug, which was launched in Europe under the Savene brand name late last year (Marketletter September 25, 2006), has also been awarded Orphan Drug status on both sides of the Atlantic. John Parsons, president of TopoTarget USA, said that the firm's dedicated sales force was "committed to working with oncology societies, including the Oncology Nurses Society, to provide educational programs to enhance extravasation awareness and support revision of...treatment guidelines." Peter Buhl Jensen, TopoTarget's chief executive, said that "the Totect US approval is a major breakthrough for TopoTarget, and for the Danish biotech industry at large." The clearance is not expected to affect the company's full-year financial guidance.
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