Express Pharma

Lupin receives US FDA approval for generic Hydroxychloroquine Sulfate tabs

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The drug is indicated for the treatment of uncomplicated malaria

Lupin has received final approval for its Hydroxychloroquine Sulfate tablets USP, 200 mg from the United States Food and Drug Administration (US FDA) to market a generic version of Concordia Pharmaceuticals’ Plaquenil Tablets, 200 mg.

Lupin’s Hydroxychloroquine Sulfate Tablets USP, 200 mg is the generic version of Concordia Pharmaceuticals’ Plaquenil Tablets, 200 mg.

The drug is indicated for the treatment of uncomplicated malaria due to P. falciparum, P. malariae, P. ovale, and P. vivax, the prophylaxis of malaria in geographic areas where chloroquine resistance is not reported, the treatment of chronic discoid lupus erythematosus and systemic lupus erythematosus in adults and the treatment of acute and chronic rheumatoid arthritis in adults.

Hydroxychloroquine Sulfate Tablets USP, 200 mg had annual sales of approximately $215.3 million in the US (IQVIA MAT April 2018).

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