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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

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

PharmAsia News Business Bulletin

A regular roundup of commercial stories appearing in Scrip’s sister publication PharmAsia News, whose multilingual team of regional experts provides authoritative business intelligence focused on the Asian marketplace. Full stories can be accessed by clicking on the story title (subscription required).

PharmAsia News Business Bulletin

A regular roundup of commercial stories appearing in Scrip’s sister publication PharmAsia News, whose multilingual team of regional experts provides authoritative business intelligence focused on the Asian marketplace. Full stories can be accessed by clicking on the story title (subscription required).

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