NDAVAGINALSUPPOSITORY
Approved
Mar 1982
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
3/8 — Basic
MONISTAT 7 (miconazole nitrate) by Design Pharmaceuticals is clinical pharmacology miconazole nitrate exhibits fungicidal activity in vitro against species of the genus candida. First approved in 1982.
Drug data last refreshed 1h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MONISTAT 7 is a vaginal suppository formulation of miconazole nitrate, a fungicidal azole antifungal indicated for vulvovaginal candidiasis and related fungal infections. The drug works by inhibiting fungal cytochrome P-450-mediated lanosterol demethylase, disrupting ergosterol synthesis and compromising fungal cell membrane integrity. It is administered intravaginally with minimal systemic absorption (<1% urinary/fecal recovery).
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30%) signals transition from growth to defensive marketing and cost management focus.
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.