FLUCONAZOLE

Post-LOESM

fluconazole

Aurobindo Pharma

ANDAORALFOR SUSPENSION1 Generic Approved

Approved

Sep 2009

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 2009.

Drug data last refreshed 11h 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)

NCT00002077N/ACompleted

An Open, Non-Comparative Study of Intravenous and Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis

Meningitis, CryptococcalHIV 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

NCT00000708N/ACompleted

Multi-center Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis

120 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

NCT00000744N/ACompleted

A Randomized, Prospective, Double-Blind Study Comparing Fluconazole With Placebo for Primary and Secondary Prophylaxis of Mucosal Candidiasis in HIV-Infected Women

400 enrolled

CandidiasisCandidiasis, EsophagealHIV 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.