NDAVAGINALSUPPOSITORY
Approved
Mar 1982
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
4/8 — Partial
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 4h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MONISTAT 7 is a vaginal suppository containing miconazole nitrate, a fungicidal azole antifungal approved in 1982 for treatment of vulvovaginal candidiasis. It works by disrupting fungal cell membrane function, with minimal systemic absorption following intravaginal administration. The product is available as a 7-day suppository regimen, though equivalent efficacy has been demonstrated with shorter 3-day dosing schedules.
LOE Approaching
Product approaching loss of exclusivity signals declining commercial investment and team consolidation; OTC positioning may limit pharma career upside.
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
Worked on MONISTAT 7 at Design Pharmaceuticals? Share your interview experience or compensation data (+7 days Pro)
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.