NDAVAGINALSUPPOSITORY
Approved
Aug 1984
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
4/8 — Partial
MONISTAT 3 (miconazole nitrate) by Design Pharmaceuticals is clinical pharmacology miconazole nitrate exhibits fungicidal activity in vitro against species of the genus candida. First approved in 1984.
Drug data last refreshed 2h ago · AI intelligence enriched 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MONISTAT 3 is a vaginal suppository containing miconazole nitrate, an azole antifungal agent indicated for vulvovaginal candidiasis (yeast infection). The drug exhibits fungicidal activity against Candida species through an unknown pharmacologic mechanism, with minimal systemic absorption following intravaginal administration.
LOE Approaching
As loss of exclusivity approaches, the brand team is contracting; roles focus on generic transition planning and market defense rather than growth initiatives.
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.