Viatris announces FDA approval for Iron Sucrose Injection

Viatris (VTRS) announced the FDA has approved Iron Sucrose Injection, USP, an intravenous iron replacement product used to treat iron deficiency anemia, or IDA, in adult and pediatric patients with chronic kidney disease, or CKD. IDA is a common complication of CKD and is associated with a significantly heightened risk of cardiovascular morbidity and higher mortality rates. Iron Sucrose Injection, USP, the first generic version of Venofer Injection, is expected to be available imminently in single dose vials in the following strengths: 50 mg/2.5mL, 100mg/5mL and 200mg/10mL. The FDA granted Viatris a competitive generic therapy designation for iron sucrose 100 mg/5 mL and 200 mg/10 mL strengths. CGT designation allows for expedited review of generic versions of medications with “inadequate generic competition.” This regulatory pathway helps to expedite market entry of generic drugs and provides eligibility for 180 days of exclusivity upon commercial marketing of the medicine. Venofer had annual sales of approximately $515M in the U.S. as of June 30 according to IQVIA.