Viatris’ Generic Iron Sucrose Gains FDA Nod
FDA has granted approval to Viatris for its generic intravenous iron replacement product as a treatment of iron deficiency anemia in adult and pediatric patients with chronic kidney disease.
Global healthcare company, Viatris, has announced the FDA’s approval of its intravenous iron replacement product, Iron Sucrose Injection, USP, making it the first approved generic version of Venofer Injection (1). This regulatory approval applies to the use of the generic iron replacement product as a treatment of iron deficiency anemia (IDA) in adult and pediatric patients aged 2 years and older with chronic kidney disease (CKD).
“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,” said Philippe Martin, Chief R&D Officer, Viatris, in a company press release (1). “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.”
IDA is commonly found in patients suffering from CKD and is known to play a significant role in the development of anemia. The use of iron formulations to help treat iron deficiency in these patients is, therefore, necessary, particularly for patients that require kidney replacement therapy (2).
“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,” added Corinne Le Goff, Chief Commercial Officer, Viatris, in the press release (1). “Iron sucrose builds on Viatris’ large and diversified global business and will further strengthen our generics portfolio.”
Viatris’ iron deficiency treatment at 100 mg/5 mL and 200 mg/10 mL has been granted a competitive generic therapy (CGT) designation from the FDA, which means it will undergo an expedited review and be eligible for 180 days exclusivity upon commercial marketing of the product. This designation is granted to generic versions of medicines that have been deemed to have “inadequate generic competition” (3).
The company, Viatris, was launched in November 2020 after the successful combination of two complementary legacy companies, Mylan and Upjohn, with the aim of providing expanded access to medicines regardless of geography or circumstance (4).
References
Viatris. Viatris Announces Approval of First Generic Iron Sucrose Injection in the U.S. Press Release, Aug. 11, 2025.
Gutiérrez, O.M. Treatment of Iron Deficiency Anemia in CKD and End-Stage Kidney Disease. Kidney Int. Rep. 2021, 6 (9), 2261–2269.
FDA. Competitive Generic Therapies. Guidance Document, October 2022.
Viatris. Viatris Inc. Launches as a New Kind of Healthcare Company, Positioned to Meet the World’s Evolving Healthcare Needs. Press Release, Nov. 16, 2020.