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 16h 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)

NCT00002294N/ACompleted

A Study of Fluconazole in the Treatment of Cryptococcal Meningitis in Patients With AIDS

Meningitis, CryptococcalHIV Infections

NCT00002339Phase 3Completed

A Study of Fluconazole in the Treatment of Fungal Infections of the Throat in Patients With Weakened Immune Systems

100 enrolled

Candidiasis, EsophagealHIV Infections

NCT00001017Phase 3Completed

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

330 enrolled

Meningitis, CryptococcalHIV Infections

NCT00002341N/ACompleted

A Study of Treatments for Fungal Infections of the Mouth and Throat in HIV-Infected Patients Who Have Had Success With Itraconazole But Not With Fluconazole

Candidiasis, OralHIV Infections

NCT00002040N/ACompleted

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

Meningitis, CryptococcalHIV 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.