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 2h ago · AI intelligence enriched 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
GRIFULVIN V is a microcrystalline oral suspension containing griseofulvin, a fungistatic agent with activity against dermatophytes including Microsporum, Epidermophyton, and Trichophyton species. It treats ringworm infections by depositing in keratin precursor cells and binding to new keratin to create a fungal-resistant barrier. The drug has been marketed since 1972 with a well-established safety and efficacy profile.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30), indicating team consolidation and shift toward operational efficiency and managed care focus.
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.