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