Daiichi's Injectafer not approvable

Daiichi Sankyo (Tokyo:4568; Osaka:4568) received a not approvable letter from FDA for an NDA for IV Injectafer ferric carboxymaltose to treat iron deficiency anemia in postpartum women or those with heavy uterine bleeding. The company said FDA requested safety data from additional clinical studies to address safety concerns, specifically a mortality signal. ...