Viatris Inc (NASDAQ:VTRS) saw its stock increase by 2.6% after the U.S. Food and Drug Administration approved its Iron Sucrose Injection, USP, marking the first generic alternative to Venofer® Injection.
This intravenous iron replacement therapy is prescribed for iron deficiency anemia in both adult and pediatric patients suffering from chronic kidney disease. The product will be available in single-dose vials across three dosage options: 50 mg/2.5mL, 100 mg/5mL, and 200 mg/10mL.
The FDA granted Viatris a competitive generic therapy (CGT) designation for the 100 mg/5 mL and 200 mg/10 mL formulations, which accelerates review and offers 180 days of market exclusivity once launched commercially.
“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, Viatris Chief R&D Officer.
Viatris developed this complex injectable internally after several years of collaboration with the FDA. The company also highlighted its pipeline of other complex injectable products in various therapeutic areas, including ferric carboxymaltose injection, another iron replacement therapy.
According to IQVIA data referenced by Viatris, Venofer® recorded approximately $515 million in U.S. sales for the 12 months ending June 30, 2025.
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