ISOVUE-M 200 (iopamidol)
Iopamidol Injection is indicated for intrathecal administration in adult neuroradiology including myelography (lumbar, thoracic, cervical, total columnar), and for contrast enhancement of computed tomographic (CECT) cisternography and ventriculography.
Details
- Status
- Prescription
- First Approved
- 1985-12-31
- Patent Cliff
- 2028
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
ISOVUE-M 200 Approval History
What ISOVUE-M 200 Treats
12 FDA approvalsOriginally approved for its first indication in 1985 . Covers 12 distinct patient populations.
- Other (12)
Other
(12 approvals)- • Approved indication (Dec 1985)
- • Approved indication (Sep 1986)
- • Approved indication (Oct 1986)
- • Approved indication (Jul 1987)
- • Approved indication (Oct 1989)
- • Approved indication (Jan 1990)
- • Approved indication (May 1990)
- • Approved indication (Sep 1990)
- • Approved indication (Jul 1992)
- • Approved indication (May 1995)
- • Approved indication (Mar 1996)
- • Approved indication (Oct 2025) NewLabel Letter
BRACCO's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
9 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04504331 results posted | IRB-53650 BRS0113, K08CA252457 | Ph 1 | terminated | Study of Infigratinib in Combination With Tamoxifen in Hormone Receptor Positive, HER2 Negative, FGFR Altered Advanced Breast Cancer |
| NCT06411795 | ANES-2023-31918 NCI-2024-02287, ANES-2023-31918 | Ph 2 | recruiting | Rectus Sheath Block With Liposomal Bupivacaine Versus Thoracic Epidural Analgesia for Pain Control Following Pancreatoduodenectomy |
| NCT03557385 ACCELERATION results posted | Pro00093001 | Ph 4 | completed | Adenosine Contrast CorrELations in Evaluating RevAscularizaTION |
| NCT01136876 results posted | IOP-117 | Ph 4 | completed | Kidney Damage in Patients With Moderate Fall in eGFR |
| NCT03384979 CA_LBW | LBW_02 | Ph 4 | completed | Optimization of Contrast Agent Dose in CT With Lean Body Weight |
| NCT01475097 results posted | GE-012-098 | Ph 4 | completed | Comparing Patient Comfort and Safety Between Iodixanol and Iopamidol in Patients Undergoing Peripheral Arteriography |
| NCT02040285 | CTC-Prep 1 | Ph 4 | completed | Low-dose Laxative Improves Performance and Feasibility of Computed Tomography Colonography (CTC) |
| NCT01376089 results posted | GE-012-097 | Ph 4 | completed | Iodixanol Versus Iopamidol in Patients Undergoing Contrast-Enhanced Computed Tomographic Imaging of Abdomen/Pelvis |
| NCT01075217 results posted | IOP 119 | Ph 4 | completed | Isovue in Peripheral Digital Subtraction Angiography (DSA) |
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.
ISOVUE-M 200 FDA Label Details
Indications & Usage
FDA Label (PDF)Iopamidol Injection is indicated for intrathecal administration in adult neuroradiology including myelography (lumbar, thoracic, cervical, total columnar), and for contrast enhancement of computed tomographic (CECT) cisternography and ventriculography. Iopamidol Injection, 41% is indicated for thoraco-lumbar myelography in children over the age of two years.
ISOVUE-M 200 Patents & Exclusivity
Exclusivity
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.