FDA approves Injectafer IV iron replacement

FDA approved a resubmitted NDA from the Luitpold Pharmaceuticals unit of Daiichi Sankyo Co. Ltd. (Tokyo:4568; Osaka:4568) for Injectafer ferric carboxymaltose to treat iron deficiency anemia. The product is indicated for use in adults who have not responded to or who are intolerant to oral iron, as well as for adults with non-dialysis dependent chronic kidney disease (CKD). Luitpold has U.S. rights to the product from Galenica Ltd. (SIX:GALN), which said Luitpold plans to launch the non-dextran IV iron replacement immediately. FDA issued a complete response letter for the product last July related to manufacturing issues. The product is approved in 46 countries and is known as Ferinject in Europe. ...