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 3h 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)

NCT00002075N/ACompleted

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

Meningitis, CryptococcalHIV Infections

NCT00002133N/ACompleted

An Open Study of the Effect of Itraconazole Oral Solution for the Treatment of Fluconazole Refractory Oropharyngeal Candidiasis in HIV-Positive Subjects.

Candidiasis, OralHIV 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

NCT00002010N/ACompleted

Open, Non-Comparative Study of Fluconazole in Patients With Coccidioidal Meningitis

MeningitisHIV Infections

NCT00000676Phase 3Completed

Randomized Comparative Study of Fluconazole Versus Clotrimazole Troches in the Prevention of Serious Fungal Infection in Patients With AIDS or Advanced AIDS-Related Complex. (A Nested Study of ACTG 081)

500 enrolled

CandidiasisMycosesHIV 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.