Amphastar Pharmaceuticals (NASDAQ:AMPH) saw its stock increase by 4% after the company announced that the FDA had approved its generic version of iron sucrose injection, a treatment used for iron deficiency anemia in patients with chronic kidney disease.
The newly authorized medication, formerly known as AMP-002, will be offered in three dosage strengths: 50mg/2.5mL, 100mg/5mL, and 200mg/10mL, all packaged in single-dose vials. Amphastar aims to launch the product during 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.”
This approval offers Amphastar a valuable market opportunity, considering the reference product Venofer® recorded approximately $513 million in U.S. sales for the 12 months ending June 30, 2025, based on IQVIA data.
Amphastar’s development pipeline includes three ANDAs and one biosimilar insulin candidate currently under FDA review, with a combined market potential exceeding $2.5 billion. Additionally, the company is advancing three biosimilars targeting a market worth over $6 billion, as well as two generic products aimed at markets totaling more than $1 billion.
Amphastar Pharmaceuticals stock price
This content is for informational purposes only and does not constitute financial, investment, or other professional advice. It should not be considered a recommendation to buy or sell any securities or financial instruments. All investments involve risk, including the potential loss of principal. Past performance is not indicative of future results. You should conduct your own research and consult with a qualified financial advisor before making any investment decisions.