Shares of Amphastar Pharmaceuticals (AMPH) surged 8.81% in pre-market trading on Monday following the announcement that the U.S. Food and Drug Administration (FDA) has approved the company's Abbreviated New Drug Application (ANDA) for Iron Sucrose Injection, USP. This generic drug is indicated for the treatment of iron deficiency anemia in patients with chronic kidney disease.

The FDA approval covers single-dose vials in dosages of 50mg/2.5mL, 100mg/5mL, and 200mg/10mL. 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 company plans to launch the product in the third quarter of 2025.

This approval positions Amphastar to enter a lucrative market. The comparable product, Venofer®, has reported sales of approximately $513 million over the past year. Investors are likely optimistic about the potential revenue boost this new product could bring to Amphastar, driving the significant pre-market stock price increase. The company's ability to successfully navigate the FDA approval process for complex generics may also be viewed positively by the market, potentially indicating future growth opportunities.