NDAINJECTIONINJECTABLE
Approved
Dec 1985
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
5
Data completeness
3/8 — Basic
ISOVUE-M 200 (iopamidol) by Bracco is x-ray contrast activity [moa]. First approved in 1985.
Drug data last refreshed Yesterday
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ISOVUE-M 200 (iopamidol) is a non-ionic radiographic contrast agent administered by injection for diagnostic imaging procedures. It enhances visualization of vascular and organ structures during X-ray and angiographic examinations, particularly in coronary and peripheral arterial imaging. The drug works through X-ray contrast activity, improving radiodensity in target tissues to enable clinical visualization.
LOE Approaching2.4 years to LOE
As a legacy diagnostic product approaching loss of exclusivity in 2.5 years, the brand team is likely focused on generic transition planning and defending market share against competitive pressure (30/100).
Mechanism of Action
X-Ray Contrast Activity
Pharmacologic Class:
Radiographic Contrast Agent
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (5)
Comparing Patient Comfort and Safety Between Iodixanol and Iopamidol in Patients Undergoing Peripheral Arteriography
Started Oct 2011
255 enrolled
Drug Safety
Iodixanol Versus Iopamidol in Patients Undergoing Contrast-Enhanced Computed Tomographic Imaging of Abdomen/Pelvis
Started May 2011
304 enrolled
Patient Comfort and Safety
Safety Study of GE-145 320 mg I/mL Injection vs. Iopamidol 370 mg I/mL in Elderly Subjects Undergoing Coronary Procedure
Started Nov 2010
284 enrolled
Chronic Renal InsufficiencyDiabete MellitusCongestive Heart Failure
Renal Safety of Iopamidol Versus Iodixanol During Coronary Angiography in Diabetic Patients
Started Mar 2009
23 enrolled
Chronic Renal ImpairmentDiabetes Mellitus
Coronary MDCTA With Iopamidol Injection 370
Started Nov 2007
210 enrolled
Coronary Artery Disease
Worked on ISOVUE-M 200 at Bracco? Share your interview experience or compensation data (+7 days Pro)
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.