New Delhi: Drug firm Lupin on Thursday said it has received final approval from the US health regulator to market its Rosuvastatin Calcium tablets used for lowering high cholesterol.
The company has received final approval from the United States Food and Drug Administration (USFDA) to market Rosuvastatin Calcium tablets in the strengths of 5 mg, 10 mg, 20 mg and 40 mg, Lupin said in a statement.
The product is a generic version of iPR Pharmaceuticals Inc’s Crestor tablets, it added.
As per IMS MAT March 2017 data, Crestor tablets had sales of USD 3.4 billion in the US, Lupin said.
The tablets are indicated for treatment of adult patients with hypertriglyceridemia, primary dysbetalipoproteinemia and patients with homozygous familial hypercholesterolemia, it added.
The company’s cumulative filings with the USFDA now stand at 368. It has received approvals for 221 products and 147 product filings are pending approval from the regulator.