Luitpold Pharmaceutical’s Injectafer (ferric carboxymaltose injection) Receives Non-Approvable Letter From FDA

March 12, 2008 – Luitpold Pharmaceuticals, Inc. reported today that the U.S. Food and Drug Administration (FDA) has issued a non-approvable letter for its new drug application (NDA) for Injectafer™ (ferric carboxymaltose injection) (Internal name VIT-45), an intravenous iron injection, for the treatment of iron deficiency anemia in women due to postpartum (PP) or heavy uterine bleeding (HUB).