Viatris Inc, a global healthcare company, today announced the U.S. Food and Drug Administration (FDA) has approved Iron Sucrose Injection, USP, an intravenous iron replacement product used to treat iron deficiency anemia (IDA) in adult and pediatric patients (2 years of age and older) with chronic kidney disease (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.

Viatris Chief R&D Officer Philippe Martin said, "The first FDA approval of a generic iron sucrose is an important advancement for patients with CKD and iron deficiency anemia and a testament to Viatris' advanced technical and manufacturing capabilities. This complex product was developed in-house, and after a number of years working closely with the FDA we are pleased to accomplish this important milestone."

Viatris' robust complex injectable pipeline includes multiple difficult-to-develop and manufacture assets across several therapeutic areas and patient types. The pipeline also includes ferric carboxymaltose injection – another iron replacement product.

Viatris Chief Commercial Officer Corinne Le Goff said, "The U.S. launch of this first-to-market generic iron sucrose will be an important addition to the treatment landscape for chronic kidney disease patients with iron deficiency, and will help increase sustainable access to this critical therapy. Iron sucrose builds on Viatris' large and diversified global business and will further strengthen our generics portfolio."

The FDA granted Viatris a competitive generic therapy (CGT) 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, 2025, according to IQVIA.

Source: prnewswire.com