NDATOPICAL, VAGINALCREAM, INSERT
Approved
Jun 2001
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
3/8 — Basic
MONISTAT 1 COMBINATION PACK (miconazole nitrate) by Design Pharmaceuticals is clinical pharmacology miconazole nitrate exhibits fungicidal activity in vitro against species of the genus candida. First approved in 2001.
Drug data last refreshed 14h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MONISTAT 1 Combination Pack is a topical antifungal containing miconazole nitrate, a fungicidal agent used to treat vulvovaginal candidiasis. It is available as a vaginal cream and insert formulation designed for rapid symptom relief with a shortened 1–3 day treatment course. Miconazole works by disrupting fungal cell membrane integrity, though the exact mechanism remains incompletely characterized.
LOE Approaching
Approaching loss of exclusivity signals contraction phase; brand team focus will shift to defending market share against generics and optimizing operational efficiency.
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.