Clinical Report: FDA Approves New Iohexol Vials

Overview

The FDA has approved new iohexol injection products from Amneal Pharmaceuticals, including 350 mg iodine/mL in various vial sizes and 300 mg iodine/mL in a 50 mL vial. These approvals represent the first generic versions referencing OMNIPAQUE.

Background

Iohexol is a nonionic, low-osmolar iodinated contrast agent used in various imaging procedures for both adult and pediatric patients. The recent approval of additional vial sizes aims to enhance the availability of this imaging agent. The safety profile of iohexol includes serious risks associated with incorrect administration.

Data Highlights

No numerical data or trial data provided in the source material.

Key Findings

• The FDA approved iohexol injection 350 mg iodine/mL in 50 mL, 75 mL, and 100 mL vials.
• Iohexol injection 300 mg iodine/mL was approved in a 50 mL vial.
• The new approvals are the first generic versions referencing OMNIPAQUE.
• Iohexol is indicated for multiple imaging procedures in patients aged 2 weeks and older.
• Boxed warnings highlight serious adverse reactions associated with incorrect intrathecal administration.

Clinical Implications

Healthcare providers should be aware of the new iohexol vial sizes.

Conclusion

The approval of new iohexol vials enhances the availability of this imaging agent.

Related Resources & Content

1. Amneal Pharmaceuticals, FDA, 2026 -- FDA Approves New Iohexol Vials
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6. These highlights do not include all the information needed to use OMNIPAQUE safely and effectively. See full prescribing information for OMNIPAQUE. OMNIPAQUE (iohexol) injection, for intrathecal, intra-arterial, intravenous, oral, rectal, intraarticular, or body cavity use OMNIPAQUE (iohexol) oral solution Initial U.S. Approval: 1985
7. Estimating the rate of acute adverse reactions to non-ionic low-osmolar contrast media: a systematic review and meta-analysis - PubMed
8. The Primary Care Management of Chronic Kidney Disease (CKD) (2025) - VA/DOD Clinical Practice Guidelines