NDAORALSUSPENSION
Approved
May 1972
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
GRIFULVIN V (griseofulvin, microcrystalline) by Johnson & Johnson is clinical pharmacology microbiology griseofulvin is fungistatic with in vitro activity against various species of microsporum, epidermophyton and trichophyton . Approved for the following ringworm infections. First approved in 1972.
Drug data last refreshed 2d ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
GRIFULVIN V is a microcrystalline oral suspension of griseofulvin, a fungistatic antifungal agent approved in 1972 for treating ringworm infections caused by Microsporum, Epidermophyton, and Trichophyton species. The drug works by depositing in keratin precursor cells with high affinity for diseased tissue, creating a highly resistant barrier to fungal invasion.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30), indicating a contracting commercial opportunity with likely headcount reductions on the brand team.
Mechanism of Action
CLINICAL PHARMACOLOGY Microbiology Griseofulvin is fungistatic with in vitro activity against various species of Microsporum, Epidermophyton and Trichophyton . It has no effect on bacteria or other genera of fungi. Pharmacokinetics Following oral administration, griseofulvin is deposited in the…
Indications (1)
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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.