NDAINJECTIONINJECTABLE
Approved
Nov 1948
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
4/8 — Partial
XYLOCAINE DENTAL (lidocaine hydrochloride) by Pfizer is 12. Approved for pain. First approved in 1948.
Drug data last refreshed 20h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Xylocaine Dental is a lidocaine hydrochloride injectable local anesthetic used for pain control in dental procedures. It works by stabilizing neuronal membranes and inhibiting ionic fluxes required for nerve impulse initiation and conduction. The formulation is designed for rapid, predictable local anesthetic action in oral and maxillofacial surgery.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100), likely signaling consolidation or divestiture discussions within the brand team.
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.