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Daiichi/Luitpold’s Injectafer “Not Approvable”

This article was originally published in PharmAsia News

Executive Summary

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