Amphastar Pharmaceuticals, Inc. received U.S. Food and Drug Administration (FDA) approval on August 11, 2025, for its Abbreviated New Drug Application (ANDA) for Iron Sucrose Injection, USP. This product, previously referred to as AMP-002, is available in 50mg/2.5mL, 100mg/5mL, and 200mg/10mL single-dose vials.
Iron sucrose injection is an iron replacement product indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD). Jack Zhang, Amphastar’s President and CEO, stated the company looks forward to launching its iron sucrose injection in the third quarter of 2025.
According to IQVIA, U.S. sales for the branded product, Venofer, were approximately $513 million for the 12 months ended June 30, 2025. This approval provides Amphastar access to a significant market, as this product previously lacked a generic competitor.
Analysts estimate AMP-002 could target about two-thirds of the Venofer market not controlled by Fresenius Medical Care AG, potentially bringing Amphastar $80 million to $100 million in sales. Amphastar expects to launch the product before the end of August, leading to meaningful sales as early as Q3 2025.
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