FDA Approves 2 Generic Iron Sucrose Injections for Iron Deficiency Anemia in CKD

Viatris Inc has announced the US Food and Drug Administration (FDA) approval of Iron Sucrose Injection, USP, an intravenous iron replacement product used to treat iron deficiency anemia (IDA) in adult and pediatric patients ≥ 2 years of age with chronic kidney disease (CKD). Concurrently, Amphastar Pharmaceuticals announced that the FDA approved the Company's Abbreviated New Drug Application for Iron Sucrose Injection, USP 50mg/2.5mL, 100mg/5mL, and 200mg/10mL in single-dose vials, previously referred to as AMP-002.1,2

According to an August 11, 2025, press release from Viatris, Iron Sucrose Injection, USP, coined by the Company as the first generic version of Venofer Injection, is expected to be available imminently in single dose vials in the following strengths: 50 mg/2.5mL, 100mg/5mL and 200mg/10mL. In a separate release, Amphastar said its generic iron sucrose injection meets the criteria for bioequivalence and therapeutic equivalence to Venofer and is expected to launch in the third quarter of 2025.1,2

"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,” Viatris Chief R&D Officer Philippe Martin said in a statement.1 “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 Viatris a competitive generic therapy (CGT) designation for iron sucrose 100 mg/5 mL and 200 mg/10 mL strengths, which allows for expedited review of generic versions of medications with "inadequate generic competition." As described in the press release, this regulatory pathway helps to expedite market entry of generic drugs and provides eligibility for 180 days of exclusivity upon commercial marketing of the medicine.1

"The US launch of this first-to-market generic iron sucrose 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,” Viatris Chief Commercial Officer Corinne Le Goff said in a statement.11“Iron sucrose builds on Viatris' large and diversified global business and will further strengthen our generics portfolio."

Amphastar, which currently has 3 Abbreviated New Drug Applications and 1 biosimilar insulin candidate filed with the FDA, also announced the approval of its generic iron sucrose injection, previously known as AMP-002, on August 11, 2025.2

"We are delighted to announce the FDA approval of our generic iron sucrose injection," said Dr. Jack Zhang, President and Chief Executive Officer of Amphastar.2 "This approval, once again, demonstrates our dedication to developing complex generics and leveraging cutting-edge, in-house manufacturing expertise to produce both active pharmaceutical ingredients and finished drug products under the highest regulatory standards in the US. We look forward to launching our iron sucrose injection in the third quarter of 2025."

References

1. Viatris Inc. Viatris Announces Approval of First Generic Iron Sucrose Injection in the U.S. 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

2. Amphastar Pharmaceuticals. Amphastar Announces FDA Approval for Iron Sucrose Injection, USP. August 11, 2025. Accessed August 12, 2025. https://ir.amphastar.com/news/amphastar-announces-fda-approval-for-iron-sucrose-injection-usp/ad4d166d-e559-4344-a042-6cc9c74f4bb7