NDAVAGINALTAMPON
Approved
Oct 1989
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
3/8 — Basic
MONISTAT 5 (miconazole nitrate) by Personal Genomics is clinical pharmacology miconazole nitrate exhibits fungicidal activity in vitro against species of the genus candida. First approved in 1989.
Drug data last refreshed 2m ago · AI intelligence enriched 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MONISTAT 5 is a vaginal miconazole nitrate suppository indicated for vulvovaginal candidiasis (yeast infections). It exhibits fungicidal activity against Candida species through an unknown pharmacologic mechanism, with minimal systemic absorption following intravaginal administration. The 5-day regimen offers comparable efficacy to the 7-day cream formulation with improved patient convenience.
LOE Approaching
As a mature OTC/Rx product approaching loss of exclusivity with moderate competitive pressure (30%), brand teams face margin compression and consolidation of commercial infrastructure.
Mechanism of Action
CLINICAL PHARMACOLOGY Miconazole nitrate exhibits fungicidal activity in vitro against species of the genus Candida. The pharmacologic mode of action is unknown. Following intravaginal administration of miconazole nitrate, small amounts are absorbed. Administration of a single dose of miconazole…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (1)
Prospective Two-Year Study to Assess Miconazole Nitrate Resistance in Neonates and Infants
Started May 2007
200 enrolled
Diaper Rash
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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.