LEVOCARNITINE SF (levocarnitine)
LEVOCARNITINE SF is indicated for the treatment of Carnitine Deficiency; Reye-like Encephalopathy; Hypoglycemia; Cardiomyopathy; Inborn Error of Metabolism.
Details
- Status
- Prescription
- First Approved
- 2019-08-14
- Routes
- ORAL
- Dosage Forms
- SOLUTION
LEVOCARNITINE SF Approval History
What LEVOCARNITINE SF Treats
5 indicationsLEVOCARNITINE SF is approved for 5 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Carnitine Deficiency
- Reye-like Encephalopathy
- Hypoglycemia
- Cardiomyopathy
- Inborn Error of Metabolism
LEVOCARNITINE SF 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.
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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 SF FDA Label Details
Indications & Usage
LEVOCARNITINE SF is indicated for the treatment of Carnitine Deficiency; Reye-like Encephalopathy; Hypoglycemia; Cardiomyopathy; Inborn Error of Metabolism.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.