OPTIRAY 320 (ioversol)
Optiray 320 is a nonionic, iodinated radiographic contrast agent indicated for use in a variety of diagnostic imaging procedures to visualize vascular and structural anatomy. In adults, it is indicated for cerebral, peripheral, visceral, and renal arteriography, as well as aortography, coronary arteriography, and left
How OPTIRAY 320 Works
This agent works by opacifying blood vessels along its flow path, allowing for the clear visualization of internal structures until the substance is diluted by the blood. While it typically moves from the vascular system into surrounding tissues in the body, it remains within the vessels of a healthy brain unless the blood-brain barrier is disrupted.
Details
- Status
- Prescription
- First Approved
- 1988-12-30
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
OPTIRAY 320 Approval History
What OPTIRAY 320 Treats
8 indicationsOPTIRAY 320 is approved for 8 conditions since its original approval in 1988. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Cerebral Arteriography
- Peripheral Arteriography
- Visceral Arteriography
- Renal Arteriography
- Aortography
- Coronary Arteriography
- Left Ventriculography
- Angiocardiography
OPTIRAY 320 Boxed Warning
RISKS WITH INADVERTENT INTRATHECAL ADMINISTRATION FOR INTRA-ARTERIAL AND INTRAVENOUS USE ONLY Inadvertent intrathecal administration may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. [see Warnings and Precautions ( 5.1 )] WARNING: RISKS WITH INADVERTENT INTRATHECAL ADMINISTRATION FOR INTRA-ARTERIAL AND INTRAVENOUS USE ONLY Inadvertent intrathecal administration may cause...
WARNING: RISKS WITH INADVERTENT INTRATHECAL ADMINISTRATION FOR INTRA-ARTERIAL AND INTRAVENOUS USE ONLY Inadvertent intrathecal administration may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. [see Warnings and Precautions ( 5.1 )] WARNING: RISKS WITH INADVERTENT INTRATHECAL ADMINISTRATION FOR INTRA-ARTERIAL AND INTRAVENOUS USE ONLY Inadvertent intrathecal administration may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. ( 5.1 )
OPTIRAY 320 Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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3 of 6FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03631771 | GE-012-103/19476/OPY-44-002 | Ph 4 | withdrawn | Pediatric Risk of Hypothyroidism With Iodinated Contrast Media |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
OPTIRAY 320 FDA Label Details
Indications & Usage
FDA Label (PDF)OPTIRAY 320 is indicated for the treatment of Cerebral Arteriography; Peripheral Arteriography; Visceral Arteriography; Renal Arteriography; Aortography; Coronary Arteriography; Left Ventriculography; Angiocardiography.
WARNING: RISKS WITH INADVERTENT INTRATHECAL ADMINISTRATION FOR INTRA-ARTERIAL AND INTRAVENOUS USE ONLY Inadvertent intrathecal administration may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.