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 23h 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 class) and levonordefrin (sympathomimetic vasoconstrictor) for injectable use in dental and surgical procedures. It works by stabilizing neuronal membranes to prevent nerve impulse initiation and transmission, with levonordefrin extending duration by reducing blood flow to the injection site. The product provides rapid onset (30 seconds to 4 minutes) and extended anesthesia duration (1-5.5 hours depending on formulation and jaw location).
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30%), indicating potential team consolidation and shift toward generic transition planning.
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.