Luitpold to meet with FDA regarding Injectafer

WASHINGTON Luitpold Pharmaceuticals will meet with the Food and Drug Administration’s Drug Safety and Risk Management Advisory Committee on Feb. 1 to discuss its drug application for the investigational iron replacement product Injectafer.

The company had filed the application back in mid-May and was seeking approval of the drug for iron deficiency anemia in heavy uterine bleeding, postpartum, inflammatory bowel disease and hemodialysis, therapy to remove waste products from the body when the kidneys are in renal failure, patients. The drug was studied in patients with heavy uterine bleeding and in a postpartum state against oral iron treatments three times daily. A study in patients with inflammatory bowel disease was also conducted.

If approved, the injectable would not be Luitpold’s first iron replacement product. The firm has marketed Venofer since 2000 for the treatment of iron deficiency anemia in patients undergoing chronic hemodialysis who are receiving supplemental erythropoietin therapy.