FDA Approves New Iohexol Vials
The approval includes additional 300 mg iodine/mL and 350 mg iodine/mL vial presentations.
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By
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Kathryn Wighton
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July 17, 2026
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Clinical Scorecard: FDA Approves New Iohexol Vials
At a Glance
| Category | Detail |
|---|
| Condition | Iohexol Injection Approval |
| Key Mechanisms | Imaging procedures via various administration routes |
| Target Population | Adult and pediatric patients aged 2 weeks and older |
| Care Setting | Imaging procedures |
Key Highlights
- Approval includes iohexol injection 350 mg iodine/mL and 300 mg iodine/mL vials
- Products to be launched in Q3 2026
- First generic versions referencing OMNIPAQUE
- Boxed warning for intrathecal administration risks
- Portfolio expected to meet majority of US market demand
Guideline-Based Recommendations
Diagnosis
- Indicated for intrathecal, intra-arterial, intravenous, oral, rectal, intraarticular, and body cavity imaging procedures
Management
- Monitor for serious adverse reactions associated with incorrect iodine concentration
Monitoring & Follow-up
- Observe for headache, nausea, back or neck pain, dizziness after intrathecal administration
Risks
- Serious adverse reactions include death, convulsions, seizures, and acute renal failure
Patient & Prescribing Data
Adults and pediatric patients aged 2 weeks and older
Administration routes include intrathecal, intra-arterial, intravenous, oral, rectal, and body cavity
Clinical Best Practices
- Ensure correct iodine concentration for intrathecal administration
- Monitor patients for adverse reactions post-administration
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