FLUCONAZOLE

Post-LOESM

fluconazole

ANI Pharmaceuticals

ANDAORALTABLET

Approved

Mar 2011

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

4/8 — Partial

FLUCONAZOLE (fluconazole) by ANI Pharmaceuticals is cytochrome p450 2c19 inhibitors [moa]. Approved for azole antifungal [epc]. First approved in 2011.

Drug data last refreshed Yesterday

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)

NCT00000951Phase 4Completed

A Study to Compare the Use of Fluconazole as Continuous Therapy Versus Periodic Therapy in HIV-Positive Patients With Recurrent Thrush

948 enrolled

Candidiasis, OralHIV Infections

NCT00000639N/ACompleted

A Randomized Double Blind Protocol Comparing Amphotericin B With Flucytosine to Amphotericin B Alone Followed by a Comparison of Fluconazole and Itraconazole in the Treatment of Acute Cryptococcal Meningitis

400 enrolled

Meningitis, CryptococcalHIV Infections

NCT00002076N/ACompleted

Pilot Study of Oral Fluconazole in the Treatment of 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

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.