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Barrett Esophagus
FDA approves Photofrin for the ablation of high-grade dysplasia
September 1st, 2003
Axcan Pharma, Inc., announced that it has received approval from the U.S Food and Drug Administration (FDA) for the use of Photofrin photodynamic therapy (PDT) in the ablation of high-grade dysplasia (HGD) in Barrett esophagus patients who do not undergo esophagectomy. The company also reported quarterly financial results. Photofrin PDT was also granted orphan drug designation for this indication, which guarantees a 7-year marketing exclusivity. Axcan said operating results for the third quarter of fiscal 2003 ended June 30, 2003, (amounts are stated in U.S. dollars). The company reported revenue growth of 32% to $46.9 million and net income of $8.7...
Source: Health & Medicine Week (2003-09-01)
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