Bottles of pills arranged on shelf at drugstore

Lupin receives FDA nod for generic Plaquenil tablets  

BY Sandra Levy

Lupin has received the green light from the Food and Drug Administration for a generic version of Concordia Pharmaceuticals’ Plaquenil tablets, 200 mg. (hydroxychloroquine sulfate tablets, 200 mg).

The product 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.

The product’s market size for the 12 months ended April 2018 was $215.3 million, according to IQVIA data.


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