Amphastar announced FDA approval of iron sucrose injection

Amphastar (AMPH) Pharmaceuticals announced yesterday morning that the Food and Drug Administration approved the company’s abbreviated new drug application for iron sucrose injection in single-dose vials, previously referred to as AMP-002. Iron sucrose injection is an iron replacement product indicated for the treatment of iron deficiency anemia n patients with chronic kidney disease. The company said, “We are delighted to announce the FDA approval of our generic iron sucrose injection. This approval, once again, demonstrates our dedicationto developing complex generics and leveraging cutting-edge, in-house manufacturing expertise to produce both active pharmaceutical ingredients and finished drug products under the highest regulatory standards in the U.S. We look forward to launching our iron sucrose injection in the third quarter of 2025.”