Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Luitpold Pharmaceuticals has reported that the FDA has issued a non-approvable letter for its new drug application for Injectafer, an intravenous iron injection for the treatment of iron deficiency anemia in women due to postpartum or heavy uterine bleeding.
Subscribe to our email newsletter
In the non-approvable letter, the FDA has requested safety data from additional clinical studies to address concerns over the safety of Injectafer in this population, specifically the mortality signal.
Mary Jane Helenek, president and CEO, said: “While we are disappointed about this latest decision, we are committed to the further development of Injectafer and are working on new studies in support of our application and to address the FDA’s concerns.”