Lupin receives USFDA final approval for Hydroxychloroquine Sulfate Tablets

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

Lupin's Hydroxychloroquine Sulfate Tablets USP, 200 mg is the generic version of Concordia Pharmaceuticals, Inc.'s Plaquenil Tablets, 200 mg. It 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 erythernatosus and systemic lupus erythematosus in adults

 

- the treatment of acute and chronic rheumatoid arthritis in adults

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

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