NDAINJECTIONINJECTABLEPriority Review
Approved
Dec 1992
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
Priority Review
CARNITOR (levocarnitine) by Leadiant Biosciences is clinical pharmacology carnitor (levocarnitine) is a naturally occurring substance required in mammalian energy metabolism. First approved in 1992.
Drug data last refreshed 3h ago · AI intelligence enriched 3d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CARNITOR (levocarnitine) is a naturally occurring carnitine analog that facilitates long-chain fatty acid entry into cellular mitochondria for energy production. It is indicated for primary and secondary carnitine deficiency, including ESRD patients on hemodialysis and those with inborn errors of metabolism such as glutaric aciduria II and propionic acidemia. The drug works by clearing toxic acylCoA compounds through formation of acylcarnitine, which is rapidly excreted, thereby reducing metabolic autointoxication.
LOE Approaching
Product is in late-stage lifecycle with LOE approaching; expect consolidation of brand team and focus on managed care and retention strategies.
Mechanism of Action
CLINICAL PHARMACOLOGY CARNITOR (levocarnitine) is a naturally occurring substance required in mammalian energy metabolism. It has been shown to facilitate long-chain fatty acid entry into cellular mitochondria, thereby delivering substrate for oxidation and subsequent energy production. Fatty acids…
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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.