Sun Pharma receives US FDA nod for cholesterol drug rosuvastatin

Sun Pharmaceutical Industries Ltd has received final approval from US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for generic version of IPR Pharmaceuticals Inc’s Crestor, rosuvastatin calcium tablets 5 mg (base), 10 mg (base), 20 mg (base) and 40 mg (base).

As per IMS MAT May 2016, these tablets have annual sales of approximately $ 6.8 billion in the US. These tablets are indicated for the treatment of adult patients with hypertriglyceridemia, primary dysbetalipoproteinemia (type III hyperlipoproteinemia) and adult patients with homozygous familial hypercholesterolemia.