NDAINJECTIONINJECTABLE
Approved
Jan 1987
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
2/8 — Basic
CHOLETEC (mebrofenin) by Bracco is clinical pharmacology mebrofenin is an iminodiacetic acid (hida) derivative with no known pharmacologic action at the recommended doses. First approved in 1987.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CHOLETEC (Mebrofenin) is a Tc-99m labeled hepatobiliary imaging agent used for diagnostic evaluation of liver and biliary tract function. It contains no pharmacologic action at recommended doses and functions as a radiopharmaceutical tracer that localizes in the hepatobiliary system. The drug is indicated for patients requiring assessment of hepatic function, bile duct patency, and gallbladder ejection fraction.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30%), signaling potential team consolidation and shift toward lifecycle management.
Mechanism of Action
CLINICAL PHARMACOLOGY Mebrofenin is an iminodiacetic acid (HIDA) derivative with no known pharmacologic action at the recommended doses. Following intravenous administration in normal subjects, Technetium Tc 99m Mebrofenin was rapidly cleared from the circulation. The mean percent injected dose…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
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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.