NDAORALPASTILLE
Approved
Apr 1987
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
5
Data completeness
3/8 — Basic
MYCOSTATIN (nystatin) by Teva is pharmacokinetics nystatin cream usp is not absorbed from intact skin or mucous membrane. First approved in 1987.
Drug data last refreshed 18h ago · AI intelligence enriched 3d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MYCOSTATIN (nystatin) is an oral pastille antifungal antibiotic that is both fungistatic and fungicidal against a wide variety of yeasts and yeast-like fungi, particularly Candida albicans. It works by binding to sterols in fungal cell membranes, causing leakage of intracellular components and cell death. Nystatin is not absorbed from intact skin or mucous membranes, making it suitable for topical and oral mucosal use.
LOE Approaching
LOE-approaching lifecycle with moderate competitive pressure (30/100) suggests team focus on retention and cost management rather than growth initiatives.
Mechanism of Action
Pharmacokinetics Nystatin Cream USP is not absorbed from intact skin or mucous membrane. Microbiology Nystatin is an antibiotic which is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi, including Candida albicans, C. parapsilosis, C. tropicalis, C.…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (5)
Gentian Violet Vs. Nystatin Oral Suspension for Treatment of Oropharyngeal Candidiasis
Started Jun 2011
221 enrolled
HIV-1 Infection
A Study to Compare Efficacy and Safety of an Ovule Containing Terconazole, Clindamycin and Fluocinolone Versus an Ovule Containing Metronidazole, Nystatin and Fluocinolone in the Treatment of Secondary Vulvar/ or Vaginal Symptoms of Infectious Vaginitis/ and Infectious Vaginosis
Started Dec 2007
160 enrolled
VaginitisInfectious Vaginosis
Nystatin Pastilles for the Prevention of Oral Candidiasis in Patients With AIDS or ARC
Candidiasis, OralHIV Infections
A Study of Nystatin in the Prevention of Fungal Infections of the Mouth in Patients With AIDS or AIDS-Related Syndromes
Candidiasis, OralHIV Infections
Comparative Randomized Study of the Efficacy, Safety, and Toleration of Fluconazole Oral Suspension or Nystatin Oral Suspension in the Treatment of Patients With Oropharyngeal Candidiasis in Association With the Acquired Immunodeficiency Syndrome
Candidiasis, OralHIV Infections
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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.