NDAINJECTIONINJECTABLEPriority Review
Approved
May 1959
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
4/8 — Partial
Priority Review
XYLOCAINE 4% PRESERVATIVE FREE (lidocaine hydrochloride) by Fresenius Kabi is 12. Approved for pain. First approved in 1959.
Drug data last refreshed 19h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
XYLOCAINE 4% PRESERVATIVE FREE is a lidocaine hydrochloride injectable local anesthetic that stabilizes neuronal membranes to block pain signal initiation and conduction. It is indicated for pain management via injection at various anatomical sites. The preservative-free formulation reduces risk of irritation in sensitive tissues or repeated-dose scenarios.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30); commercial teams face revenue decline and transition planning as market consolidates.
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.