NDABUCCALTABLET
Approved
Apr 2010
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
5
Data completeness
3/8 — Basic
ORAVIG (miconazole) by Galt Pharmaceuticals is 12. First approved in 2010.
Drug data last refreshed 18h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ORAVIG (miconazole 50 mg) is a buccal tablet antifungal approved in 2010 for oromucosal candidiasis. It works by inhibiting fungal cytochrome P450 14α-demethylase, disrupting ergosterol synthesis and increasing reactive oxygen species in Candida cells. The product delivers high local salivary concentrations with minimal systemic absorption, making it a localized treatment option.
LOE Approaching
Product is in late-stage lifecycle approaching loss of exclusivity, suggesting smaller commercial team focus and potential transition planning.
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…
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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.