Amphastar Pharmaceuticals, a biopharmaceutical company focused on developing, manufacturing and marketing complex generic and proprietary injectable, inhalation and intranasal products, announces that the US Food and Drug Administration (FDA) has approved the company's Abbreviated New Drug Application (ANDA) for iron sucrose injection, USP 50 mg/2.5 mL, 100 mg/5 mL and 200 mg/10 mL in single-dose vials, previously referred to as AMP-002.
Iron sucrose injection is an iron replacement product indicated for the treatment of iron deficiency anaemia (IDA) in patients with chronic kidney disease (CKD).
"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 US."
"We look forward to launching our iron sucrose injection in the third quarter of 2025."
According to IQVIA, the US sales for Venofer were approximately $513m for the 12 months ended 30 June 2025.
The company currently has three abbreviated new drug applications (ANDAs) and one biosimilar insulin candidate filed with the FDA targeting products with a combined market size exceeding $2.5bn.
It also has three biosimilar products in development targeting products with a market size exceeding $6bn and two generic products in development targeting products with a market size of more than $1bn.
This market information is based on IQVIA data for the 12 months ended 30 June 2025. The company is developing multiple proprietary products with injectable and intranasal dosage forms.