NDAINJECTIONINJECTABLE
Approved
Jan 1993
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
4
Data completeness
4/8 — Partial
OMNISCAN (gadodiamide) by GE HealthCare is magnetic resonance contrast activity [moa]. Approved for paramagnetic contrast agent [epc]. First approved in 1993.
Drug data last refreshed 2m ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OMNISCAN (gadodiamide) is a paramagnetic contrast agent administered via injection to enhance magnetic resonance imaging (MRI) visualization of tissue and blood vessels. It works by altering the magnetic properties of nearby water molecules, improving image clarity and diagnostic accuracy. The drug is indicated for use as a contrast medium in MRI procedures across multiple anatomical regions.
LOE Approaching
As LOE approaches, the brand team is likely in maintenance or transition mode with reduced headcount and focus shifting toward managed decline strategies.
Mechanism of Action
Magnetic Resonance Contrast Activity
Pharmacologic Class:
Paramagnetic Contrast Agent
Indications (1)
Clinical Trials (4)
Post-marketing Safety Study in Patients With Moderate Renal Insufficiency Who Receive Omniscan for Contrast-enhanced Magnetic Resonance Imaging (MRI)
Started May 2009
213 enrolled
Chronic Kidney DiseaseRenal Insufficiency
A Safety and Efficacy Clinical Study to Evaluate the Narrowing of the Aorto-iliac Arteries While Using Gadodiamide
Started Sep 2004
407 enrolled
Aorto-iliac StenosisArterial Occlusive Diseases
A Safety & Efficacy Clinical Study to Evaluate the Narrowing of the Renal Arteries While Using Gadodiamide
Started Sep 2003
395 enrolled
Renal Artery Stenosis
A Study of Gadodiamide Injection in Myocardial Perfusion Magnetic Resonance Imaging
Started Jul 2003
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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.