Keryx Biopharmaceuticals announces filing of NDA for Ferric Citrate in Japan Keryx Biopharmaceuticals announced that its Japanese partner, Japan Tobacco, has filed its New Drug Application 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. Under the license agreement with JT and its subsidiary Torii Pharmaceutical Co. within 30 days, Keryx will receive a non-refundable payment of $7M for the achievement of the NDA filing milestone.
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