NDAORALSOLUTIONPriority Review
Approved
Sep 1954
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
4/8 — Partial
Priority Review
XYLOCAINE VISCOUS (lidocaine hydrochloride) by Fresenius Kabi is 12. Approved for pain. First approved in 1954.
Drug data last refreshed 1w ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Xylocaine Viscous is a topical oral solution containing lidocaine hydrochloride, a local anesthetic that stabilizes neuronal membranes to inhibit pain signal transmission. It is indicated for pain relief in the oral cavity and throat. The drug works by blocking ionic fluxes required for nerve impulse initiation and conduction.
LOE Approaching
This product is approaching loss of exclusivity with moderate competitive pressure (30), indicating a brand team focused on maximizing remaining market share and preparing for generic transition.
Mechanism of Action
12.1 Mechanism of Action Lidocaine hydrochloride stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses thereby effecting local anesthetic action. 12.2 Pharmacodynamics Excessive blood levels may cause changes in cardiac output, total…
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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.