NYSTOP

Post-LOESM

nystatin

Design Pharmaceuticals

ANDATOPICALPOWDER

Approved

Aug 1996

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

5/8 — Partial

NYSTOP (nystatin) by Design Pharmaceuticals is clinical pharmacology pharmacokinetics nystatin is not absorbed from intact skin or mucous membrane. Approved for the treatment of cutaneous, mucocutaneous mycotic infections caused by candida albicans, other susceptible candida species. First approved in 1996.

Drug data last refreshed 18h ago

$0.0BPart D

Mechanism of Action

CLINICAL PHARMACOLOGY Pharmacokinetics Nystatin 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.…

Pharmacologic Class:

Polyene Antifungal

Indications (3)

the treatment of cutaneous

Worked on NYSTOP 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.

Clinical Trials (5)

NCT01427738Phase 3Completed

Gentian Violet Vs. Nystatin Oral Suspension for Treatment of Oropharyngeal Candidiasis

Started Jun 2011

221 enrolled

HIV-1 Infection

NCT01867164Phase 3Completed

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

NCT00002112N/ACompleted

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

NCT00002057N/ACompleted

Nystatin Pastilles for the Prevention of Oral Candidiasis in Patients With AIDS or ARC

Candidiasis, OralHIV Infections

NCT00002293N/ACompleted

A Study of Nystatin in the Prevention of Fungal Infections of the Mouth in Patients With AIDS or AIDS-Related Syndromes

Candidiasis, OralHIV Infections