An iron sucrose injection demonstrated bioequivalence and therapeutic equivalence to Venofer for treating iron deficiency anemia in patients with chronic kidney disease.

Amphastar Pharmaceuticals, Inc. reported that the U.S. Food and Drug Administration (FDA) approved its Abbreviated New Drug Application for iron sucrose injection, USP, in single-dose vials of 50 mg/2.5 mL, 100 mg/5 mL, and 200 mg/10 mL. The formulation, formerly designated AMP-002.

Commercial launch is planned for the third quarter of 2025. According to IQVIA, U.S. sales of Venofer totaled approximately $513 million for 12 months, ending June 30, 2025.

Amphastar produces both active pharmaceutical ingredients and finished drug products in-house under U.S. regulatory standards. The company’s development portfolio includes three additional abbreviated new drug applications and one biosimilar insulin candidate that have been filed with the FDA, as well as three biosimilars and twogeneric products that are currently in development.

Source: Amphastar Pharmaceuticals