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Data updated: Mar 10, 2026

SOVUNA

HYDROXYCHLOROQUINE SULFATE
Immunology Approved 2022-01-14
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1
Indication
--
Phase 3 Trials
4
Years on Market

Details

Status
Prescription
First Approved
2022-01-14
Routes
ORAL
Dosage Forms
TABLET

Companies

NOVITIUM PHARMA
Active Ingredient: HYDROXYCHLOROQUINE SULFATE

SOVUNA Approval History

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What SOVUNA Treats

4 indications

SOVUNA is approved for 4 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Malaria
  • Rheumatoid Arthritis
  • Systemic Lupus Erythematosus
  • Chronic Discoid Lupus Erythematosus
Source: FDA Label

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

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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.

SOVUNA FDA Label Details

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Indications & Usage

FDA Label (PDF)

1 INDICATIONS & USAGE SOVUNA is an antimalarial and antirheumatic indicated for the: Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale, and Plasmodium vivax in adult and pediatric patients. Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients. Treatment of rheumatoid arthritis in adults. Treatment of systemic lupus erythematosus in adults. Treatment of chronic discoid lupus erythematosus in adults. Limitations of Use : SOVUNA is not recommended for the: Treatment of complicat...

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Data Sources

FDA Approval: NDA214581 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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