FLUCONAZOLE

Post-LOESM

fluconazole

Inpharmus

ANDAORALFOR SUSPENSION

Approved

Sep 2023

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

5/8 — Partial

FLUCONAZOLE (fluconazole) by Inpharmus is cytochrome p450 2c19 inhibitors [moa]. Approved for azole antifungal [epc]. First approved in 2023.

Drug data last refreshed 2d ago

$0.0BPart D

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)

NCT00005920Phase 2Terminated

Safety and Effectiveness of Giving L-743,872 to Patients With Thrush That Has Not Been Cured With Fluconazole

70 enrolled

Candidiasis, OralHIV Infections

NCT00002075N/ACompleted

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

Meningitis, CryptococcalHIV 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

NCT00002305N/ACompleted

A Comparison of Fluconazole and Amphotericin B in the Treatment of 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.