NDASPINALINJECTABLEPriority Review
Approved
Nov 1968
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
4/8 — Partial
Priority Review
XYLOCAINE 1.5% W/ DEXTROSE 7.5% (lidocaine hydrochloride) by Fresenius Kabi is 12. Approved for pain. First approved in 1968.
Drug data last refreshed 1w ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Xylocaine 1.5% with Dextrose 7.5% is a spinal anesthetic containing lidocaine hydrochloride, a local anesthetic that stabilizes neuronal membranes to block pain signal initiation and conduction. It is indicated for spinal anesthesia to manage acute pain during surgical procedures. The dextrose component provides specific gravity adjustment for CSF distribution in the spinal space.
LOE Approaching
As a legacy spinal anesthetic with loss of exclusivity approaching, the brand faces commoditization pressure; expect smaller commercial teams focused on defending market share against generics.
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.