Amneal Pharmaceuticals has received U.S. FDA approval for additional strengths and vial presentations of iohexol injection, expanding its contrast agent portfolio. The approvals cover 350 mg iodine/mL in 50 mL, 75 mL, and 100 mL vials, as well as 300 mg iodine/mL in a 50 mL vial, with a planned launch in the third quarter of 2026. These new presentations complement the company's previously approved 300 mg iodine/mL in 100 mL vials and are the first generic versions referencing OMNIPAQUE across these presentations. Amneal expects its iohexol portfolio to now address the majority of U.S. market demand, which IQVIA estimates at approximately $706 million in annual sales for the 12 months ended May 2026.
Amneal Pharmaceuticals, Inc. Class A Common StockFDA approval expands iohexol portfolio, addressing majority of $706M market.