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news.Amag Pharmaceuticals, a biopharmaceutical company, has received a complete response letter from the FDA for ferumoxytol for the treatment of iron deficiency anemia in chronic kidney disease patients. The company has submitted its new drug application for marketing approval of ferumoxytol in December 2007.
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The company believes that it can address the issues raised by the FDA in its complete response letter in a timely manner without conducting any additional clinical trials prior to approval. In addition, the company continues preparations for the intended commercial launch of ferumoxytol during the first quarter of 2009.
Brian Pereira, president and CEO of Amag Pharmaceuticals, said: “We believe that we will be able to provide the information requested by the FDA in an expeditious manner. We will continue to work closely with the FDA and look forward to bringing ferumoxytol to market, which if approved, could provide a new treatment option for chronic kidney disease patients with iron deficiency anemia.”