FDA Approves New Iohexol Vials
The approval includes additional 300 mg iodine/mL and 350 mg iodine/mL vial presentations.
By
Kathryn Wighton
July 17, 2026
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 Related Resources & Content
