Keryx Biopharmaceuticals Inc. announced that Japan Tobacco Inc. has filed its New Drug Application (NDA) with the Japanese Ministry of Health, Labour and Welfare for marketing approval of ferric citrate in Japan for the treatment of hyperphosphatemia in patients with chronic kidney disease. The NDA filing is supported by efficacy and safety data from several successfully completed Phase 3 studies in CKD patients with hyperphosphatemia in Japan.
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- Japan Tobacco Inc. Announces Filing of New Drug Application for Marketing Approval of Ferric Citrate in Japan for the Treatment of Hyperphosphatemia in Patients with Chronic Kidney Disease