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)

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

NCT00002394N/ACompleted

Safety and Effectiveness of Giving Lamisil to HIV-Positive Subjects With Thrush Who Have Not Responded to Fluconazole Treatment

30 enrolled

Candidiasis, OralHIV Infections

NCT00002040N/ACompleted

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

Meningitis, CryptococcalHIV Infections

NCT00002306N/ACompleted

A Study of Fluconazole in the Treatment of Cryptococcal Meningitis in Patients Who Have Not Had Success With Amphotericin B

Meningitis, CryptococcalHIV Infections

NCT00002277Phase 3Completed

A Comparison of Fluconazole and Amphotericin B in the Treatment of Fungal Infections

MycosesHIV 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.