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Hydroxychloroquine (sulfate) is approved by both the FDA and EMA for the treatment of systemic lupus erythematosus (SLE), including discoid and systemic forms of lupus erythematosus. It is widely considered a first-line therapy for lupus due to its immunomodulatory and anti-inflammatory properties, with strong evidence for reduction in flare frequency, maintenance of remission, and prevention of severe organ damage.
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