Amphastar Pharmaceuticals has received US FDA approval for its Abbreviated New Drug Application (ANDA) for iron sucrose injection, USP 50 mg/2.5 mL, 100 mg/5 mL, and 200 mg/10 mL in single-dose vials, previously referred to as AMP-002. According to the FDA, the injection meets the criteria for bioequivalence and therapeutic equivalence to Venofer and is an iron replacement product indicated for the treatment of iron deficiency anemia in patients with chronic kidney disease.