Viatris Inc (Nasdaq:VTRS), a US-based global healthcare company, announced on Monday that the US Food and Drug Administration (FDA) has approved Iron Sucrose Injection, USP, an intravenous iron replacement product used to treat iron deficiency anaemia (IDA) in adult and paediatric patients (2 years of age and older) with chronic kidney disease (CKD).

IDA is a common complication of CKD and is associated with a significantly heightened risk of cardiovascular morbidity and higher mortality rates. Iron Sucrose Injection, USP, the first generic version of Venofer Injection, is expected to be available imminently in single dose vials in the following strengths: 50 mg/2.5mL, 100mg/5mL, and 200mg/10mL.

The FDA granted Viatris a competitive generic therapy (CGT) designation for iron sucrose 100 mg/5 mL and 200 mg/10 mL strengths. CGT designation allows for expedited review of generic versions of medications with 'inadequate generic competition.'