Sandoz launches affordable iron sucrose injection for treatment of iron deficiency anemia in patients with chronic kidney disease in US

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4:15 PM on Wednesday, September 24

The Associated Press

PRINCETON, N.J.--(BUSINESS WIRE)--Sep 24, 2025--

Sandoz (SIX: SDZ; OTCQX: SDZNY), the global leader in affordable medicines, today announced the US launch of its generic iron sucrose injection following recent approval by the US Food and Drug Administration (FDA) 1. The product is now available for order and delivery across the United States. The launch of this iron sucrose formulation further expands the Sandoz US iron therapy portfolio.

Intravenous iron sucrose is a cornerstone therapy for iron deficiency anemia, which impacts approximately five million US patients. This includes those with chronic kidney disease (CKD stages 3-5), which puts nearly 19 million Americans at high risk for anemia 2-5. It is administered at dialysis centers nationwide, providing essential iron replacement to foster red blood cell production. Iron sucrose is approved to treat all indications of the reference medicine, Venofer®* 6.

“Our launch of iron sucrose proves again that we remain committed to pioneering access to more affordable medicines for patients with chronic conditions,” said Keren Haruvi, President Sandoz North America. “We are proud to offer a high-quality, reliable alternative that helps patient, clinician and supply needs in the US.”

Iron deficiency anemia occurs when the body does not have enough iron to make healthy red blood cells, which are essential for carrying oxygen throughout the body. Iron is important not only for hemoglobin production but also for maintaining a healthy immune system, muscles, skin, hair, and nails. People with chronic kidney disease, women who menstruate, those who are pregnant or breastfeeding, and individuals with certain gastrointestinal conditions are at higher risk for iron deficiency anemia. Symptoms may include fatigue, shortness of breath, pale skin, weakness, and light headedness 7. When oral iron is not effective or cannot be absorbed, intravenous iron sucrose is often used to replenish iron stores and support the body’s production of new red blood cells 7.

Sandoz iron sucrose injection was developed in partnership with RAFARM, S.A.

*Venofer® is a registered trademark of Vifor (International) Inc.

ABOUT IRON SUCROSE
INDICATIONS
Iron sucrose injection is an iron replacement product indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD).

SELECT IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
Known hypersensitivity to iron sucrose.
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions: Observe for signs and symptoms of hypersensitivity during and after iron sucrose administration for at least 30 minutes and until clinically stable following completion of each administration. Only administer iron sucrose when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. Hypotension: May cause hypotension. Monitor for signs and symptoms of hypotension during and following each administration. Iron Overload: Regularly monitor hematologic responses during therapy. Do not administer to patients with iron overload.
ADVERSE REACTIONS
Adult patients: The most common adverse reactions (≥2%) are diarrhea, nausea, vomiting, headache, dizziness, hypotension, pruritus, pain in extremity, arthralgia, back pain, muscle cramp, injection site reactions, chest pain and peripheral edema. Pediatric patients: The most common adverse reactions (≥2%) are headache, respiratory tract viral infection, peritonitis, vomiting, pyrexia, dizziness, cough, nausea, arteriovenous fistula thrombosis, hypotension, and hypertension.

This is not the complete list of all the safety information for Iron Sucrose Injection. Please click to see the full Prescribing Information for Iron Sucrose Injection.

REFERENCES
[1] US Food & Drug Association. ANDA 212340. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212340. [Last accessed: September 2025]
[2] Charytan, C., Levin, N., Al-Saloum, M., Hafeez, T., Gagnon, S., & Van Wyck, D. B. (2001). Efficacy and safety of iron sucrose for iron deficiency in patients with dialysis-associated anemia: North American clinical trial. The American Journal of Kidney Diseases: The Official Journal of the National Kidney Foundation, 37(2), 300–307. https://doi.org/10.1053/ajkd.2001.21293 [Last accessed: September 2025]
[3] American Medical Association. What doctors wish patients knew about iron deficiency. Available at: https://www.ama-assn.org/public-health/prevention-wellness/what-doctors-wish-patients-knew-about-iron-deficiency. [Last accessed: September 2025]
[4] National Health Institute National Institute of Diabetes and Digestive and Kidney Diseases. 2024 Annual Data Report. Available at: https://usrds-adr.niddk.nih.gov/2024. [Last accessed: September 2025]
[5] Center for Disease Control. Chronic Kidney Disease in the United States, 2023. Available at: https://www.cdc.gov/kidney-disease/php/data-research/?CDC_AAref_Val=https://www.cdc.gov/kidneydisease/publications-resources/ckd-national-facts.html. [Last accessed: September 2025]
[6] U.S. Food and Drug Administration. FDA Approved Indications for Venofer®. Available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021135s038lbl.pdf. [Last accessed: September 2025]
[7] American Society of Hematology. Iron-Deficiency Anemia. Available at https://www.hematology.org/education/patients/anemia/iron-deficiency. [Last accessed: September 2025]

DISCLAIMER
This Media Release contains forward-looking statements, which offer no guarantee with regard to future performance. These statements are made on the basis of management’s views and assumptions regarding future events and business performance at the time the statements are made. They are subject to risks and uncertainties including, but not confined to, future global economic conditions, exchange rates, legal provisions, market conditions, activities by competitors and other factors outside of the control of Sandoz. Should one or more of these risks or uncertainties materialize or should underlying assumptions prove incorrect, actual outcomes may vary materially from those forecasted or expected. Each forward-looking statement speaks only as of the date of the particular statement, and Sandoz undertakes no obligation to publicly revise any forward-looking statements, except as required by law.

ABOUT SANDOZ
Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in affordable medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 people of 100 nationalities work together to ensure 900 million patient treatments are provided by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,300 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the world’s first oral penicillin in 1951, and the world’s first biosimilar in 2006. In 2024, Sandoz recorded net sales of USD 10.4 billion.

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