NDATOPICALSOLUTIONPriority Review
Approved
Mar 1964
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
XYLOCAINE (lidocaine) by AstraZeneca is clinical pharmacology mechanism of action: lidocaine stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action. Approved for facial wrinkles and folds, nasolabial folds, midface volume deficit and 6 more indications. First approved in 1964.
Drug data last refreshed 1w ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
XYLOCAINE (lidocaine) is a local anesthetic that stabilizes neuronal membranes by inhibiting ionic fluxes required for impulse initiation and conduction. It is indicated for acute pain, postoperative pain, neuropathic pain, procedural pain, and cosmetic applications including facial wrinkles and lip augmentation. The topical solution has a rapid onset of 3-5 minutes and is well-absorbed from mucous membranes.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30), signaling transition from growth to decline phase requiring defensive strategies and potential team restructuring.
Mechanism of Action
CLINICAL PHARMACOLOGY Mechanism of action: Lidocaine stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action. Onset of anesthesia: Lidocaine Ointment 5% effects local, topical anesthesia. The…
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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.