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Sandoz Launches Generic Ferumoxytol
The first generic of the high-dose intravenous iron, a generic of Feraheme, is now available.
Sandoz has launched the generic of ferumoxytol, an intravenous medicine used to treat iron deficiency anemia (IDA). Sandoz officials said they initially plan to make ferumoxytol available to patients in the hospital and clinic setting. Intravenous administration of iron has been shown to be more effective, more rapidly, than a prolonged course of oral iron therapy in patients with IDA.
“This launch delivers on our strategy to continue to build our hospital and clinic portfolio and provide U.S. patients access to affordable generic medicines that work as well as brand-name products,” Keren Haruvi, president of Sandoz, said in a statement.
Ferumoxytol, a generic equivalent to AMAG Pharmaceuticals’ Feraheme, is approved to treat IDA in adult patients who have an intolerance to oral iron or have had an unsatisfactory response to oral iron, or who have chronic kidney disease. Covid Pharma acquired AMAG in November 2020.
FDA officials note Sandoz was the first applicant for generic ferumoxytol injection.
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
