India Pharma Outlook Team | Tuesday, 12 August 2025
The international healthcare company Viatris Inc. reported that iron sucrose injection, USP, an injectable iron replacement product, has been approved by the US Food and Drug Administration (FDA) to treat iron deficiency anemia (IDA) in adult and pediatric patients with chronic kidney disease (CKD) who are two years of age or older.
Patients with CKD frequently have IDA, a condition that is linked to significantly higher cardiovascular morbidity and mortality. The first generic version of Venofer injection, iron sucrose injection, USP, is anticipated to be made available soon in single dosage vials and in the following strengths: 50 mg/2.5 mL, 100 mg/5 mL, and 200 mg/10 mL.
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 anaemia 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."
Representing our extensive complex injectables pipeline, Viatris has several challenging-to-develop and manufacture assets in various therapeutic areas and patient types. This pipeline also includes ferric carboxymaltose injection – another iron replacement product for treatment options.
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Viatris chief commercial officer Corinne Le Goff said, "The US 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."
