Bridgewater, N.J., July 17, 2026
Amneal Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved additional strengths and vial presentations of iohexol injection, including 350 mg iodine/mL in 50 mL, 75 mL, and 100 mL vials, as well as 300 mg iodine/mL in 50 mL vials. The company plans to commercially launch the newly approved products during the third quarter of 2026, further expanding its injectable contrast media portfolio for hospitals and imaging centers.
Expanded Portfolio Enhances Supply and Clinical Flexibility
The newly approved presentations complement Amneal’s previously launched iohexol injection 300 mg iodine/mL in 100 mL vials, creating a comprehensive portfolio designed to address the majority of U.S. demand for iohexol injection. The expanded product range provides healthcare providers, hospitals, and diagnostic imaging centers with greater flexibility in selecting appropriate vial sizes while strengthening supply availability across multiple clinical settings.
First Generic Versions Across Approved Presentations
The approvals represent the first generic versions referencing OMNIPAQUE™ for the newly approved strengths and vial presentations. Iohexol injection is indicated for multiple diagnostic imaging procedures, including intrathecal, intra-arterial, intravenous, oral, rectal, intra-articular, and body cavity imaging in adults and pediatric patients aged two weeks and older, making it a widely used radiographic contrast agent across healthcare facilities.
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Strengthening Leadership in Complex Injectables
According to IQVIA data, the U.S. iohexol injection market generated approximately $706 million in annual sales for the 12 months ending May 2026. The latest FDA approvals reinforce Amneal’s strategy to expand its leadership in complex injectables and hospital products, while increasing access to high-quality generic contrast agents that support diagnostic imaging and patient care throughout the United States.
Source: Amneal Pharmaceuticals press release
