Amphastar Pharmaceuticals Secures FDA Approval for Iron Sucrose Injection, Expands Complex Generic Portfolio

Amphastar Pharmaceuticals received FDA approval for Iron Sucrose Injection, a treatment for iron deficiency anemia in patients with chronic kidney disease. The product is bioequivalent to Venofer, a leading treatment, and Amphastar plans to launch it in Q3 2025. The U.S. market for Venofer is $513 million, and Amphastar's pipeline targets markets exceeding $9.5 billion. However, market competition and execution risks associated with new product launches are concerns.

Amphastar Pharmaceuticals, Inc. (NASDAQ: AMPH) has received approval from the U.S. Food and Drug Administration (FDA) for its Iron Sucrose Injection, a treatment for iron deficiency anemia in patients with chronic kidney disease. The product, previously known as AMP-002, has been granted approval in three dosage strengths: 50mg/2.5mL, 100mg/5mL, and 200mg/10mL, all packaged in single-dose vials. The approval follows the company's commitment to developing complex generics and leveraging its in-house manufacturing expertise [1].

The FDA found that the Iron Sucrose Injection meets the criteria for bioequivalence and therapeutic equivalence to Venofer, a leading treatment for iron deficiency anemia. Venofer, developed by Vifor Pharma and now part of CSL Ltd., was approved in the U.S. in 2000 and has recorded approximately $513 million in U.S. sales for the 12 months ending June 30, 2025 [2].

Amphastar plans to launch the Iron Sucrose Injection in the third quarter of 2025. The approval presents a valuable market opportunity for the company, considering the significant sales of Venofer. However, market competition and execution risks associated with new product launches are notable concerns [3].

Amphastar's development pipeline includes three abbreviated new drug applications (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].

This approval is part of Amphastar's broader strategy to expand its product portfolio and capitalize on the growing demand for complex generics and biosimilars. The company's stock price saw a 12% increase to $26.71 following the announcement, reflecting investor optimism about the potential of the new product [2].

References:
[1] https://www.biospace.com/press-releases/amphastar-announces-fda-approval-for-iron-sucrose-injection-usp
[2] https://www.tradingview.com/news/DJN_DN20250811007507:0-viatris-amphastar-pharmaceuticals-get-fda-approvals-of-iron-sucrose-products/
[3] https://investorshub.advfn.com/market-news/article/14485/amphastar-shares-rise-following-fda-approval-of-generic-iron-sucrose-injection