Viatris Inc., a global healthcare company, has announced a significant achievement with the U.S. Food and Drug Administration (FDA) approval of Iron Sucrose Injection, USP. This marks the first generic version of Venofer® Injection to be approved in the United States and is intended to treat iron deficiency anemia (IDA) in adult and pediatric patients (2 years and older) who have chronic kidney disease (CKD). IDA is a common and serious complication of CKD, and this approval is expected to provide a more accessible and cost-effective treatment option.

The product will be available in single-dose vials in three strengths: 50 mg/2.5mL, 100 mg/5mL, and 200 mg/10mL. The FDA's approval underscores Viatris's advanced technical and manufacturing capabilities, as this was a complex product to develop. This approval is a testament to the company's robust pipeline of complex injectable assets across various therapeutic areas.

Further accelerating its market entry, Viatris's application for the 100 mg/5 mL and 200 mg/10 mL strengths was granted a Competitive Generic Therapy (CGT) designation. This regulatory pathway is designed to expedite the review of generic medications for which there is inadequate competition. The CGT designation provides Viatris with eligibility for 180 days of market exclusivity, which begins upon commercial launch of the product. The branded product, Venofer®, had annual U.S. sales of approximately $515 million as of June 30, 2025, highlighting the significant market and patient need this generic version will address.

Iron Sucrose Injection is for intravenous use and is contraindicated in patients with a known hypersensitivity to iron sucrose. It comes with important warnings and precautions, including the potential for serious hypersensitivity reactions, such as anaphylaxis, which can be life-threatening. Patients should be monitored for signs of hypersensitivity during and after administration. The drug may also cause clinically significant hypotension, and the risk of iron overload with excessive parenteral iron therapy should be considered. Periodic monitoring of hematologic and iron parameters is essential.

Common adverse reactions in adults include nausea, headache, and diarrhea, while in pediatric patients, they include headache, respiratory infections, and vomiting. The drug can also cause injection site reactions and other side effects. Use in specific populations, such as pregnant or geriatric patients, requires careful consideration. It's important to note that iron sucrose may reduce the absorption of oral iron preparations taken at the same time. This new generic option from Viatris aims to expand access to a critical therapy while maintaining a focus on safety and efficacy.