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U.S. FDA Panel Mulls Safety Of Luitpold’s Intravenous Iron

This article was originally published in PharmAsia News

Executive Summary

U.S. FDA's Drug Safety and Risk Advisory Committee meets Feb. 1 to discuss patient deaths in trials of Daiichi Sankyo's U.S. subsidiary Luitpold's Injectafer (ferric carboxymaltose) for treatment of anemia in postpartum patients and those with heavy uterine bleeding

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The U.S. FDA's Drug Safety and Risk Management Advisory Committee will not recommend that the agency approve Daiichi Sankyo's U.S. subsidiary Luitpold's Injectafer for first-line treatment of iron deficiency anemia in postpartum patients and those with heavy uterine bleeding, the panel decided at its Feb. 1 meeting

U.S. FDA Panel Votes Against First-line Use For Luitpold’s Iron Deficiency Drug Injectafer

The U.S. FDA's Drug Safety and Risk Management Advisory Committee will not recommend that the agency approve Daiichi Sankyo's U.S. subsidiary Luitpold's Injectafer for first-line treatment of iron deficiency anemia in postpartum patients and those with heavy uterine bleeding, the panel decided at its Feb. 1 meeting

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Daiichi Sankyo's U.S. subsidiary Luitpold Pharmaceuticals announced May 14 that it has submitted an NDA for Injectafer (ferric carboxymaltose), an intravenous iron replacement product for iron deficiency anemia

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