NDATOPICALLOTION
Approved
Sep 1992
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
OXISTAT (oxiconazole nitrate) by ANI Pharmaceuticals is clinical pharmacology pharmacokinetics the penetration of oxiconazole nitrate into different layers of the skin was assessed using an in vitro permeation technique with human skin. First approved in 1992.
Drug data last refreshed 23h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OXISTAT (oxiconazole nitrate) is a topical imidazole antifungal agent approved in 1992 for treating dermatophyte and yeast infections of the skin. It works by inhibiting ergosterol biosynthesis, disrupting fungal cell membrane integrity. The drug is applied topically as a cream or lotion and has minimal systemic absorption (<0.3% urinary recovery).
$0.251MPart D
LOE ApproachingMinimal commercial activity with <300 annual Part D claims signals a niche, mature product with limited growth trajectory and likely small commercial infrastructure.
Mechanism of Action
CLINICAL PHARMACOLOGY Pharmacokinetics The penetration of oxiconazole nitrate into different layers of the skin was assessed using an in vitro permeation technique with human skin. Five hours after application of 2.5 mg/cm of oxiconazole nitrate cream onto human skin, the concentration of…
Indications
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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.