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USFDA approval for anti-cholesterol tablet by Lupin

Lupin will now market a generic version of Teva’s Fenofibrate Tablets in the American market

Pharmaceutical major Lupin Ltd recently announced that it has received the approval from USFDA to market the generic version of Teva’s Fenofibrate Tablets in the American market, an anti-cholesterol tablet. A generic version of Teva’s Fenofibrate Tablets, 54 mg and 160 mg, has a US sales of $156 million.

“Lupin’s US subsidiary, Lupin Pharmaceuticals Inc. would commence promoting the product shortly in the US,” the company said, as reported by IANS.

According to Lupin, its Fenofibrate tablets 54 mg and 160 mg are the AB rated generic equivalent of the current reference listed drug, Fenofibrate Tablets 54 mg and 160 mg of Teva.

“It is indicated as an adjunct to diet to reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia and for treatment of adult patients with severe hypertriglyceridemia,” the statement said.

However Angel Broking’s vice president research, pharma, Sarabjit Kour Nangra is of the view that the drug may not contribute to Lupin’s financials in a major way.

Nangra said the drug is mainly used to reduce cholesterol levels in patients at risk of cardiovascular disease.

“Like other fibrates, it reduces low-density lipoprotein (LDL) and very low density lipoprotein (VLDL) levels, as well as increasing high-density lipoprotein (HDL) levels and reducing triglyceride levels,” she said.

According to her, though the drug is highly competitive and hence unlikely to contribute significantly to the company, its getting approval is positive as the approval has come from Lupin’s Goa plant, which underwent USFDA audit.

On the other hand Lupin said it has close to 20 percent market share of the overall US Fenofibrate market.

The company is the 6th largest and fastest growing top five generics player in the US, it said, adding it now has 81 products in the market and is the market leader in 31 products marketed in the US generics market.

The company is amongst the top three by market share in 55 products.

Cumulative ANDA (abbreviated new drug application) filings with the US FDA stood at 215, as on June 30, 2015 with the company having received 120 approvals to date. The company has 35 First-to-Files (FTF) products which includes 15 exclusive FTF opportunities

Source: IANS
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