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 10h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Carbocaine w/ Neo-Cobefrin is a local anesthetic combination containing mepivacaine hydrochloride (amide-type anesthetic) and levonordefrin (vasoconstrictor) used for infiltration and regional anesthesia in dental and surgical procedures. It stabilizes neuronal membranes to prevent nerve impulse transmission, providing rapid onset (30 seconds to 4 minutes) and extended duration of anesthesia (1-5.5 hours depending on concentration and anatomical site). The amide structure allows hepatic metabolism rather than plasma esterase degradation, with elimination primarily via renal excretion within 30 hours.
LOE Approaching
Long-established product with LOE approaching; commercial teams face defensive positioning and cost-containment focus rather than growth expansion.
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.