Amphastar stock rises after FDA approves generic iron sucrose injection
Investing.com -- Amphastar Pharmaceuticals (NASDAQ:AMPH) stock gained 4% after the company announced FDA approval for its generic version of iron sucrose injection, a treatment for iron deficiency anemia in patients with chronic kidney disease.
The newly approved product, previously referred to as AMP-002, will be available in three dosage forms: 50mg/2.5mL, 100mg/5mL, and 200mg/10mL in single-dose vials. Amphastar plans to launch the product in the third quarter of 2025.
"We are delighted to announce the FDA approval of our generic iron sucrose injection," said Dr. Jack Zhang, Amphastar’s President and Chief Executive Officer. "This approval, once again, demonstrates our dedication to developing complex generics and leveraging cutting-edge, in-house manufacturing expertise to produce both active pharmaceutical ingredients and finished drug products under the highest regulatory standards in the U.S."
The approval represents a significant opportunity for Amphastar, as the reference product Venofer® generated approximately $513 million in U.S. sales for the 12 months ended June 30, 2025, according to IQVIA data.
Amphastar’s pipeline includes three ANDAs and one biosimilar insulin candidate currently under FDA review, targeting products with a combined market size exceeding $2.5 billion. The company is also developing three biosimilar products targeting a market exceeding $6 billion and two generic products aimed at a market of over $1 billion.
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