FLUCONAZOLE

Post-LOESM

fluconazole

Dr. Reddy's Laboratories

ANDAORALTABLET

Approved

Jul 2004

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

4/8 — Partial

FLUCONAZOLE (fluconazole) by Dr. Reddy's Laboratories is cytochrome p450 2c19 inhibitors [moa]. Approved for azole antifungal [epc]. First approved in 2004.

Drug data last refreshed 18h 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)

NCT00000708N/ACompleted

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

120 enrolled

Meningitis, CryptococcalHIV Infections

NCT00002074N/ACompleted

Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Maintenance Treatment for the Prevention of Relapse of Cryptococcal Meningitis in Patients With Acquired Immunodeficiency Syndrome

Meningitis, CryptococcalHIV 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

NCT00002038N/ACompleted

Non-Comparative Study of Fluconazole in Patients With Serious Mycoses and Who Cannot Be Treated With Conventional Antifungal Therapy

CandidiasisMycosesHIV Infections

NCT00002325N/ACompleted

A Study of Fluconazole in the Prevention of Fungal Infections in HIV-Infected Patients Living in Areas Where Fungal Infections Are Common

MycosesHIV InfectionsCoccidioidomycosis

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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.