FLUCONAZOLE

Post-LOESM

fluconazole

Dr. Reddy's Laboratories

ANDAORALTABLET

Approved

Feb 2017

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 2017.

Drug data last refreshed 21h 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)

NCT00002038N/ACompleted

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

CandidiasisMycosesHIV 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

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

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

NCT00000708N/ACompleted

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

120 enrolled

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.