Viatris Inc. announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its Iron Sucrose Injection, USP. This approval marks a significant milestone as it is the first generic version of Venofer® Injection.
The Iron Sucrose Injection, USP, is indicated for the treatment of iron deficiency anemia in adult and pediatric patients with chronic kidney disease. This condition represents a substantial medical need in the United States.
Venofer® Injection, the branded reference product, had annual U.S. sales exceeding $515 million. The approval of a generic alternative positions Viatris to enter this market and capture a share of these sales.
This product launch is expected to contribute to Viatris's new product revenues and further strengthen its diversified generics portfolio. The ability to bring complex generic products to market is a key component of the company's growth strategy.
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