Viatris Gains FDA Approval for First Generic Iron Sucrose Injection in the United States
Tuesday, August 12, 2025
Viatris Inc. has received approval from the United States Food and Drug Administration (FDA) for Iron Sucrose Injection, USP, an intravenous iron replacement therapy for treating iron deficiency anaemia (IDA) in adults and children aged two years and older with chronic kidney disease (CKD). IDA is a common complication of CKD, linked to higher cardiovascular risk and increased mortality rates.
This product is the first generic version of Venofer® Injection and will be available in single-dose vials in strengths of 50 mg/2.5 mL, 100 mg/5 mL, and 200 mg/10 mL.
The approval was granted under the Competitive Generic Therapy (CGT) designation for the 100 mg/5 mL and 200 mg/10 mL strengths, which provides expedited review and 180 days of market exclusivity upon launch.
Viatris developed the product in-house as part of its complex injectable portfolio, which includes multiple challenging-to-produce therapies across different treatment areas. The company’s pipeline also features ferric carboxymaltose injection, another iron replacement treatment.
According to IQVIA, Venofer® recorded annual sales of around 515 million US dollars in the United States as of 30 June 2025.
Source: prnewswire.com
