AMAG Pharmaceuticals, Inc. (AMAG) Announces Submission of a Type II Variation for Rienso Label Expansion in Europe to Include All Adult Iron Deficiency Anemia Patients Who Cannot Take Oral Iron
6/7/2013 9:32:15 AM
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LEXINGTON, Mass., June 7, 2013 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (Nasdaq:AMAG) today announced that its European commercial partner, Takeda Pharmaceutical Company Limited, has submitted a type-II variation to the European Medicines Agency (EMA) for Rienso® (ferumoxytol). The submission requests EMA approval to expand the indication for ferumoxytol beyond the current indication for the treatment of iron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD) to include all adult patients with IDA who have a history of unsatisfactory oral iron therapy or in whom oral iron cannot be used.
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