LEVOCARNITINE · NOVITIUM PHARMA
Levocarnitine oral solution is indicated in the treatment of primary systemic carnitine deficiency. In the reported cases, the clinical presentation consisted of recurrent episodes of Reye-like encephalopathy, hypoketotic hypoglycemia, and/or cardiomyopathy. Associated symptoms included hypotonia, muscle weakness and failure to thrive.
Details
- Status
- Prescription
- First Approved
- 1985-12-27
- Routes
- ORAL, INJECTION
- Dosage Forms
- SOLUTION, INJECTABLE, TABLET
LEVOCARNITINE Approval History
What LEVOCARNITINE Treats
5 indicationsLEVOCARNITINE is approved for 5 conditions since its original approval in 2001. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Carnitine Deficiency
- Reye-like Encephalopathy
- Hypoglycemia
- Cardiomyopathy
- Inborn Error of Metabolism
LEVOCARNITINE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to LEVOCARNITINE
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Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03953703 | irb200020 | Ph 2 | completed | Levocarnitine for Dry Eye in Sjogren's Syndrome |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
LEVOCARNITINE FDA Label Details
Indications & Usage
FDA Label (PDF)Levocarnitine oral solution is indicated in the treatment of primary systemic carnitine deficiency. In the reported cases, the clinical presentation consisted of recurrent episodes of Reye-like encephalopathy, hypoketotic hypoglycemia, and/or cardiomyopathy. Associated symptoms included hypotonia, muscle weakness and failure to thrive. A diagnosis of primary carnitine deficiency requires that serum, red cell and/or tissue carnitine levels be low and that the patient does not have a primary defect in fatty acid or organic acid oxidation (see CLINICAL PHARMACOLOGY ). In some patients, particular...
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LEVOCARNITINE SF
Full clinical data, patents, trials, and competitive landscape for levocarnitine.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.