NDATOPICALSOLUTION
Approved
Oct 1997
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
6
Data completeness
2/8 — Basic
Drug data last refreshed 23h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LAMISIL (terbinafine hydrochloride) is a topical antifungal solution approved in 1997 for the treatment of fungal infections of the skin, including tinea pedis, tinea cruris, and tinea corporis. It works by inhibiting squalene epoxidase, disrupting fungal cell membrane synthesis. This product serves as a first-line topical treatment for dermatophyte infections in ambulatory care settings.
LOE Approaching
As LOE approaches, the brand team is likely contracting and shifting focus to generic transition planning or line extension strategies to maintain market presence.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (6)
SINGLE-APPLICATION TERBINAFINE HYDROCHLORIDE (1%) TOPICAL LIQUID SOLUTION VERSUS A SINGLE-APPLICATION BUTENAFINE HYDROCHLORIDE (1%) TOPICAL LIQUID SOLUTION FOR THE TREATMENT OF TINEA PEDIS
Started Jan 2019
42 enrolled
Tinea Pedis
Fed Study of Terbinafine Hydrochloride Tablets 250 mg and Lamisil® 250 mg
Started Feb 2004
36 enrolled
Healthy
Fasting Study of Terbinafine Hydrochloride Tablets 250 mg and Lamisil® Tablets 250 mg
Started Feb 2004
36 enrolled
Healthy
Bioequivalence Study of Terbinafine Hydrochloride Tablets, 250 mg of Dr. Reddy's Under Fasting Conditions
Started Jan 2002
36 enrolled
Fasting
Bioequivalence Study of Terbinafine Hydrochloride Tablets, 250 mg of Dr. Reddy's Under Fed Conditions
Started Jan 2002
18 enrolled
Healthy
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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.