Iron deficiency anaemia (IDA) is a common complication in chronic kidney disease, and is linked with increased cardiovascular risks and mortality.
Viatris’ Iron Sucrose Injection is an intravenous iron replacement product and will be available imminently in single-dose vials of 50mg/2.5ml, 100mg/5ml, and 200mg/10ml, offering a cost-effective alternative to existing treatments.
Iron Sucrose Injection is claimed to be the first generic version of Venofer Injection.
Viatris chief R&D officer Philippe Martin stated, “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’ injectable pipeline includes an iron replacement product, ferric carboxymaltose injection.
The company’s 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.”
The FDA granted Viatris a competitive generic therapy (CGT) designation for the 100mg/5ml and 200mg/10ml strengths, allowing for expedited market entry and 180 days of exclusivity on the commercial marketing of the drug.