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news.Galenica's US partner Luitpold Pharmaceuticals has submitted a New Drug Application (NDA) with the US FDA for Injectafer used to treat iron deficiency anaemia.
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Injectafer is a non-dextran intravenous iron (i.v.) replacement therapy containing ferric carboxymaltose as its active pharmaceutical ingredient.
The NDA includes the data from two randomized controlled clinical trials which assessed the cardiovascular risk profile of Injectafer.
Of the two large scale, multi-center, randomized clinical trials, one trial compares Injectafer to Venofer (iron sucrose injection) in patients with iron deficiency anaemia and chronic kidney disease.
The second study compares Injectafer to either oral or intravenous (i.v.) iron (standard of care therapy) in patients with iron deficiency anaemia of various etiologies.