Viatris Receives FDA Approval for First Generic Iron Sucrose Injection in the U.S.
Tuesday, August 12, 2025
Viatris has gained approval from the U.S. Food and Drug Administration (FDA) for its Iron Sucrose Injection, USP, marking the first generic version of Venofer® Injection available in the country.
The medicine is used for intravenous treatment of iron deficiency anaemia (IDA) in adults and children aged two years and above with chronic kidney disease (CKD).
IDA is a frequent complication in CKD and is linked to an increased risk of cardiovascular problems and higher mortality rates. The approved product will be supplied in single-dose vials in strengths of 50 mg/2.5 mL, 100 mg/5 mL, and 200 mg/10 mL, and is expected to be launched soon.
The iron sucrose injection was developed in-house by Viatris after several years of collaboration with the FDA. It forms part of the company’s growing portfolio of complex injectables, which includes a range of products across various therapeutic areas. The portfolio also features ferric carboxymaltose injection, another iron replacement therapy.
The FDA has granted Competitive Generic Therapy (CGT) designation to the 100 mg/5 mL and 200 mg/10 mL strengths of the product.
CGT status supports faster approval of medicines where there is limited generic competition and offers 180 days of market exclusivity once the product is commercially launched.
Source: viatris.com
