Lupin receives FDA approval for generic Crestor® tablets

Pharma Major Lupin Limited (Lupin) announced that it 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 (FDA) to market a generic version of iPR Pharmaceuticals, Inc’s Crestor® tablets.


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.

Crestor® tablets had US sales of USD 3.4 billion (IMS MAT March 2017).

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