NDAVAGINALTAMPON
Approved
Oct 1989
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
4/8 — Partial
MONISTAT 5 (miconazole nitrate) by Personal Genomics is clinical pharmacology miconazole nitrate exhibits fungicidal activity in vitro against species of the genus candida. Approved for vulvovaginal candidiasis, candidiasis, tinea cruris and 1 more indications. First approved in 1989.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MONISTAT 5 (miconazole nitrate) is a vaginal antifungal suppository approved in 1989 for treating vulvovaginal candidiasis and other fungal infections. It exhibits fungicidal activity against Candida species through an unknown pharmacologic mechanism, with minimal systemic absorption following intravaginal administration. The 3-day suppository regimen provides comparable efficacy to 7-day topical cream formulations.
LOE Approaching
Product is in late-stage lifecycle with no current patent protection; brand team focus is likely on defensive maintenance and potential transition to generic partner models.
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 (4)
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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.