FLUCONAZOLE

Post-LOESM

fluconazole

Aurobindo Pharma

ANDAORALTABLET1 Generic Approved

Approved

Oct 2008

Lifecycle

Post-LOE

Competitive Pressure

45/100

Clinical Trials

Data completeness

4/8 — Partial

FLUCONAZOLE (fluconazole) by Aurobindo Pharma is cytochrome p450 2c19 inhibitors [moa]. Approved for azole antifungal [epc]. First approved in 2008.

Drug data last refreshed 3d ago

Mechanism of Action

Cytochrome P450 2C19 Inhibitors

Pharmacologic Class:

Azole Antifungal

Indications

Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.

Clinical Trials (20)

NCT00001017Phase 3Completed

Comparison of Fluconazole and Amphotericin B in the Treatment of Brain Infections in Patients With AIDS

330 enrolled

Meningitis, CryptococcalHIV Infections

NCT00000826Phase 1Completed

Effect of Fluconazole, Clarithromycin, and Rifabutin on the Pharmacokinetics of Sulfamethoxazole-Trimethoprim and Dapsone and Their Hydroxylamine Metabolites

48 enrolled

Bacterial InfectionsMycosesHIV Infections

NCT00000627N/ACompleted

Pilot Study to Determine the Feasibility of Fluconazole for Induction Treatment and Suppression of Relapse of Histoplasmosis in Patients With the Acquired Immunodeficiency Syndrome

90 enrolled

HIV InfectionsHistoplasmosis

NCT00000788Phase 1Completed

A Study to Assess the Effect of Concomitant Administration of Fluconazole on the Clinical Pharmacokinetics of Methadone

24 enrolled

CandidiasisHIV Infections

NCT00002282N/ACompleted

A Comparison of the Safety and Effectiveness of Fluconazole or Clotrimazole in the Treatment of Fungal Infections of the Mouth and Throat in Patients With AIDS

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.