NDAORALTABLETPriority Review
Approved
May 2011
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
19
Data completeness
7/8 — Comprehensive
Priority Review
DIFICID (fidaxomicin) by Merck & Co. is 12. Approved for clostridium difficile infection, clostridium difficile-associated diarrhea. First approved in 2011.
Drug data last refreshed 20h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DIFICID (fidaxomicin) is an oral macrolide antibacterial approved in 2011 for the treatment of Clostridioides difficile infection (CDI). It acts locally in the gastrointestinal tract with minimal systemic absorption, working through hydrolysis to form its active metabolite OP-1118. The drug demonstrates dose-dependent efficacy and is positioned as a targeted, locally-acting alternative to systemically absorbed antibiotics for CDI management.
$0.1BPart D
1.7 years to LOEMechanism of Action
12.1 Mechanism of Action Fidaxomicin is an antibacterial drug [see ] . 12.2 Pharmacodynamics Fidaxomicin acts locally in the gastrointestinal tract on C. difficile . In a dose-ranging trial (N=48) of fidaxomicin using 50 mg, 100 mg, and 200 mg twice daily for 10 days, a dose-response relationship…
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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.