GRISEOFULVIN

Post-LOE

griseofulvin

Novartis

ANDAORALSUSPENSION

Approved

Oct 2010

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

5/8 — Partial

GRISEOFULVIN (griseofulvin) by Novartis is clinical pharmacology griseofulvin absorption from the gastrointestinal tract varies considerably among individuals mainly because of insolubility of the drug in aqueous media of the upper gi tract. Approved for dermatophyte infections of the skin not adequately treated by topical therapy, hair, nails and 2 more indications. First approved in 2010.

Drug data last refreshed 18h ago

$0.0BPart D

Mechanism of Action

CLINICAL PHARMACOLOGY Griseofulvin absorption from the gastrointestinal tract varies considerably among individuals mainly because of insolubility of the drug in aqueous media of the upper GI tract. Drug absorption has been estimated to range between 27 and 72%. After an oral dose, griseofulvin is…

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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.

Clinical Trials (3)

NCT04318535Phase 1Completed

Bioequivalence (BE) Study of Test Griseofulvin 500 Milligram (mg) Tablets Versus Reference and Dose Proportionality Study of Test Griseofulvin 250 mg and 500 mg Tablets Under Fed Conditions

Started Jan 2020

36 enrolled

Antifungal Agents

NCT00117754Phase 3Completed

Terbinafine Compared to Griseofulvin in Children With Tinea Capitis

Started Jul 2004

720 enrolled

Tinea Capitis

NCT00117767Phase 3Completed