NDAINJECTIONINJECTABLEPriority Review
Approved
Oct 1978
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
5
Data completeness
3/8 — Basic
Priority Review
MONISTAT (miconazole) by Johnson & Johnson is 12. First approved in 1978.
Drug data last refreshed 18h ago · AI intelligence enriched 4d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MONISTAT (miconazole) is a small-molecule antifungal agent that inhibits ergosterol synthesis in fungal cell membranes, disrupting critical membrane components. It is indicated for treatment of various Candida infections, including oral candidiasis (via buccal tablet formulation ORAVIG) and other fungal infections. The drug has been a mainstay antifungal therapy since its approval in 1978.
LOE Approaching
As LOE approaches, the brand team is likely focused on lifecycle management and transition planning rather than growth initiatives.
Mechanism of Action
12.1 Mechanism of Action Miconazole is an antifungal drug 12.3 Pharmacokinetics Absorption and Distribution Salivary Single dose application of ORAVIG containing 50 mg of miconazole to the buccal mucosa of 18 healthy volunteers provided mean maximum salivary concentrations of 15 mcg/mL at 7 hours…
Worked on MONISTAT at Johnson & Johnson? 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.