FDA Approvals for Iron Sucrose Products by Viatris, Amphastar Pharmaceuticals

Viatris and Amphastar Pharmaceuticals have received FDA approval for generic iron sucrose injection products to treat iron deficiency anemia in patients with chronic kidney disease. Viatris' drug is a generic version of Venofer, while Amphastar's drug meets bioequivalence and therapeutic equivalence criteria. Amphastar shares rose 12% to $26.71, and Viatris rose 2% to $9.94. Viatris received a competitive generic therapy designation and will launch a 50 mg/2.5mL version. Amphastar received approval for USP 50mg/2.5mL, 100mg/5mL, and 200mg/10mL strengths.

In a significant move for the healthcare industry, the U.S. Food and Drug Administration (FDA) has approved generic versions of iron sucrose injection for treating iron deficiency anemia in patients with chronic kidney disease (CKD). This approval has led to a notable increase in stock prices for both Amphastar Pharmaceuticals (NASDAQ: AMPH) and Viatris Inc. (NASDAQ: VTRS).

Amphastar Pharmaceuticals announced that the FDA has approved its generic iron sucrose injection, formerly known as AMP-002, in three dosage strengths: 50mg/2.5mL, 100mg/5mL, and 200mg/10mL. The company expects to launch the product during the third quarter of 2025 [1]. Amphastar's stock price rose by 4% following the announcement.

Viatris Inc., on the other hand, received FDA approval for Iron Sucrose Injection, USP, which is a generic version of Venofer® Injection. The drug is available in single-dose vials in the strengths of 50 mg/2.5mL, 100mg/5mL, and 200mg/10mL. Viatris received a competitive generic therapy (CGT) designation for the 100mg/5mL and 200mg/10mL strengths, which allows for expedited review and 180 days of exclusivity upon commercial marketing [2].

The approval of these generic versions offers a substantial market opportunity, considering the reference product Venofer® recorded approximately $513 million in U.S. sales for the 12 months ending June 30, 2025 [1].

Amphastar's development pipeline includes three ANDAs and one biosimilar insulin candidate currently under FDA review, with a combined market potential exceeding $2.5 billion. Additionally, the company is advancing three biosimilars targeting a market worth over $6 billion, as well as two generic products aimed at markets totaling more than $1 billion [1].

Viatris' robust pipeline includes multiple difficult-to-develop and manufacture assets across several therapeutic areas and patient types. The pipeline also includes ferric carboxymaltose injection – another iron replacement product [2].

The FDA approvals have had a positive impact on the stocks of both companies. Amphastar's shares rose by 12% to $26.71, while Viatris' shares rose by 2% to $9.94.

References:
[1] https://investorshub.advfn.com/market-news/article/14485/amphastar-shares-rise-following-fda-approval-of-generic-iron-sucrose-injection
[2] https://newsroom.viatris.com/2025-08-11-Viatris-Announces-Approval-of-First-Generic-Iron-Sucrose-Injection-in-the-U-S