Viatris (VTRS) has received FDA approval for Iron Sucrose Injection, USP, an intravenous iron replacement therapy for treating iron deficiency anemia in adult and pediatric patients with chronic kidney disease (CKD). The approval covers 100 mg/5 mL and 200 mg/10 mL strengths and includes a competitive generic therapy designation.
Philippe Martin, Viatris’ Chief R&D Officer, highlighted that this marks the first FDA approval of a generic iron sucrose in the U.S., underscoring the company’s technical expertise and manufacturing capabilities. Developed entirely in-house, the product’s approval follows years of collaboration with the FDA and represents a significant milestone for patients and the company.