Lupin receives USFDA approval for generic Crestor tablets

03 Aug 2017 Evaluate

Lupin has received final approval for its Rosuvastatin Calcium Tablets 5 mg, 10 mg, 20 mg and 40 mg from the United States Food and Drug Administration (USFDA) to market a generic version of iPR Pharmaceuticals, Inc’s Crestor tablets. Crestor tablets had US sales of $3.4 billion as per IMS MAT March 2017.

Lupin’s Rosuvastatin Calcium tablets 5 mg, 10 mg, 20 mg and 40 mg is the AB rated generic equivalent of iPR Pharmaceuticals, Inc’s Crestor tablets. It is indicated for the treatment of adult patients with hypertriglyceridemia, primary dysbetalipoproteinemia (Type III hyperlipoproteinemia) and adult patients with homozygous familial hypercholesterolemia.

Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally.


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