USFDAJul 17, 2026, 08:02 AM
Amneal Receives FDA Approval for Expanded Iohexol Injection Portfolio
AI Summary
Amneal Pharmaceuticals announced it has received U.S. Food and Drug Administration (FDA) approval for additional strengths and vial presentations of iohexol injection. This includes 350 mg iodine/mL in 50 mL, 75 mL, and 100 mL vials, and 300 mg iodine/mL in a 50 mL vial. The company plans to launch these products in the third quarter of 2026, positioning its iohexol portfolio to address the majority of the U.S. market demand for the radiographic contrast agent, which had approximately $706 million in U.S. annual sales.
Key Highlights
- Amneal received FDA approval for iohexol injection 350 mg iodine/mL in 50 mL, 75 mL, and 100 mL vials.
- FDA also approved iohexol injection 300 mg iodine/mL in 50 mL vial.
- These are the first generic versions referencing OMNIPAQUE™ across the approved presentations.
- Amneal plans to launch these products in the third quarter of 2026.
- The expanded portfolio is expected to address the majority of U.S. iohexol injection market demand.
- U.S. annual sales for iohexol injection were approximately $706 million for the 12 months ended May 2026.
Price Impact
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