Amphastar Pharmaceuticals Secures FDA Approval for Generic Iron Sucrose Injection for Treating Iron Deficiency Anemia
Reuters
Aug 11
<a href="https://laohu8.com/S/AMPH">Amphastar Pharmaceuticals</a> Secures FDA Approval for Generic Iron Sucrose Injection for Treating Iron Deficiency Anemia
Amphastar Pharmaceuticals Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted approval for their Abbreviated New Drug Application (ANDA) for Iron Sucrose Injection, USP. This approval applies to single-dose vials in dosages of 50mg/2.5mL, 100mg/5mL, and 200mg/10mL. The iron sucrose injection is indicated for the treatment of iron deficiency anemia in patients with chronic kidney disease. Dr. Jack Zhang, Amphastar's President and CEO, expressed enthusiasm for the approval, highlighting the company's commitment to developing complex generics and maintaining high regulatory standards. The product is expected to launch in the third quarter of 2025. This development positions Amphastar to enter a market where existing sales for Venofer®, a comparable product, reached approximately $513 million over the past year.
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