Drug firm Lupin today 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.
According to IMS MAT March 2017 data, Crestor tablets had sales of $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.
Shares of Lupin today ended at Rs 994.90 per scrip, down 3.80 per cent from the previous close.
Comments
Comments have to be in English, and in full sentences. They cannot be abusive or personal. Please abide by our community guidelines for posting your comments.
We have migrated to a new commenting platform. If you are already a registered user of TheHindu Businessline and logged in, you may continue to engage with our articles. If you do not have an account please register and login to post comments. Users can access their older comments by logging into their accounts on Vuukle.