NDAINJECTIONINJECTABLEPriority Review
Approved
Jan 1960
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
2/8 — Basic
Priority Review
CARBOCAINE W/ NEO-COBEFRIN (levonordefrin; mepivacaine hydrochloride) by Sanofi is clinical pharmacology isocaine stabilizes the neuronal membrane and prevents the initiation and transmission of nerve impulses, thereby effecting local anesthesia. First approved in 1960.
Drug data last refreshed 22h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CARBOCAINE W/ NEO-COBEFRIN is a combination local anesthetic containing mepivacaine hydrochloride and levonordefrin (a vasoconstrictor) administered by injection for dental and oral surgical procedures. The mepivacaine component stabilizes neuronal membranes to block nerve impulse initiation and transmission, while levonordefrin prolongs anesthetic duration by reducing blood flow to the injection site. Onset is rapid (30 seconds to 4 minutes) with duration extending from 20 minutes to 5.5 hours depending on dosage strength and jaw location.
LOE Approaching
As a legacy local anesthetic approaching loss of exclusivity with moderate competitive pressure (30%), commercial teams are likely consolidating and transitioning toward generic transition management.
Mechanism of Action
CLINICAL PHARMACOLOGY ISOCAINE stabilizes the neuronal membrane and prevents the initiation and transmission of nerve impulses, thereby effecting local anesthesia. ISOCAINE is rapidly metabolized, with only a small percentage of the anesthetic (5 to 10 percent) being excreted unchanged in the…
Indications
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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.