AMAG Pharma (AMAG) Expects FDA Action Letter for Feraheme(TM) Injection Within Next Few Days
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AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) announced last night that it has not received an action letter from the U.S. FDA for Feraheme(TM) (ferumoxytol) Injection for the treatment of iron deficiency anemia in adult chronic kidney disease patients. The Prescription Drug User Fee Act action date was today, June 29, 2009. The FDA informed the Company that the Agency would not take action today, but expects to issue an action letter within the next few days. The FDA has not requested any additional information from the Company, and it is the Company's understanding that there are no outstanding issues regarding the Feraheme New Drug Application.
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