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

This article was originally published in PharmAsia News

Executive Summary

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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Luitpold must conduct additional clinical trials to gain U.S. FDA approval of Injectafer for first-line treatment of iron deficiency anemia in women with postpartum and heavy uterine bleeding, the Daiichi Sankyo subsidiary reported March 12 after receiving a "not approvable" letter from the agency

Daiichi/Luitpold’s Injectafer “Not Approvable”

Luitpold must conduct additional clinical trials to gain U.S. FDA approval of Injectafer for first-line treatment of iron deficiency anemia in women with postpartum and heavy uterine bleeding, the Daiichi Sankyo subsidiary reported March 12 after receiving a "not approvable" letter from the agency

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

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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