FDA approves first generic iron sucrose injection for iron deficiency anemia in CKD

The FDA has approved Viatris Inc’s iron sucrose injection, USP, for the treatment of iron deficiency anemia (IDA) in adult and pediatric patients 2 years and older with chronic kidney disease (CKD). The intravenous product is the first generic version of Venofer (iron sucrose; American Regent) injection and will be available in single-dose vials in 50-mg/2.5-mL, 100-mg/5-mL, and 200-mg/10-mL strengths.

IDA is a frequent complication of CKD and is associated with a significantly heightened risk of cardiovascular morbidity and higher mortality rates, stated Viatris in a press release.

“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, chief R&D officer at Viatris. “This complex product was developed in house, and after a number of years working closely with the FDA, we are pleased to accomplish this important milestone.”

The FDA granted competitive generic therapy (CGT) designation to the 100-mg/5-mL and 200-mg/10-mL strengths, which allows for expedited review of generic versions of medications with inadequate competition and provides eligibility for 180 days of market exclusivity.

Corinne Le Goff, chief commercial officer at Viatris, said the US launch “will be an important addition to the treatment landscape for chronic kidney disease patients with iron deficiency, and will help increase sustainable access to this critical therapy. Iron sucrose builds on Viatris’ large and diversified global business and will further strengthen our generics portfolio.”

Iron sucrose injection carries contraindications for patients with known hypersensitivity to the product. Serious hypersensitivity reactions, including life-threatening and fatal anaphylactic-type reactions, have been reported and may present with shock, clinically significant hypotension, loss of consciousness, and collapse.

If such reactions or signs of intolerance occur, administration should be stopped immediately, and patients should be monitored for at least 30 minutes following infusion.

Iron sucrose may also cause clinically significant hypotension, which can be related to the rate of administration or total dose delivered. Excessive therapy may result in iron overload and iatrogenic hemosiderosis; periodic monitoring of hematologic and iron parameters is recommended.

In adults, the most common adverse reactions (≥2%) include diarrhea, nausea, vomiting, headache, dizziness, hypotension, pruritus, pain in extremity, arthralgia, back pain, muscle cramps, injection site reactions, chest pain, and peripheral edema.

In 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.

Reference

Viatris Announces Approval of First Generic Iron Sucrose Injection in the U.S. Viatris. August 11, 2025. Accessed August 12, 2025. https://newsroom.viatris.com/2025-08-11-Viatris-Announces-Approval-of-First-Generic-Iron-Sucrose-Injection-in-the-U-S#:~:text=Press%20Releases,/5mL%20and%20200mg/10mL