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Data updated: Mar 10, 2026

STALEVO 125

CARBIDOPA DOPA Decarboxylase Inhibitors
Neurology Approved 2003-06-11
1
Indication
--
Phase 3 Trials
22
Years on Market

Details

Status
Prescription
First Approved
2003-06-11
Routes
ORAL
Dosage Forms
TABLET

Companies

Active Ingredient: CARBIDOPA , ENTACAPONE , LEVODOPA

STALEVO 125 Approval History

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What STALEVO 125 Treats

7 indications

STALEVO 125 is approved for 7 conditions since its original approval in 2003. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Parkinson's Disease
  • Post-Encephalitic Parkinsonism
  • Symptomatic Parkinsonism
  • Carbon Monoxide Intoxication
  • Manganese Intoxication
  • Nausea
  • Vomiting
Source: FDA Label

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Trial Timeline

Full development history with FDA approval milestones

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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.

STALEVO 125 FDA Label Details

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Indications & Usage

FDA Label (PDF)

Carbidopa and levodopa tablets are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. Carbidopa allows patients treated for Parkinson's disease to use much lower doses of levodopa. Some patients who responded poorly to levodopa have improved on carbidopa and levodopa tablets. This is most likely due to decreased peripheral decarboxylation of levodopa caused by administration of carbidopa rather than by a primary effect of carbidopa on the nervous system. Carbidop...

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.