Lupin gets US regulator approval for cholesterol drug

The market in the US for the drug is valued close to $1.5 billion

Pharma major Lupin on Tuesday announced it has received final approval for marketing additional strengths of cholesterol-lowering drug Antara capsules in the American market.

The company has received final approval for its supplemental New Drug Application (sNDA) for Antara (Fenofibrate) capsules in 30 mg and 90 mg strengths from the US Food and Drug Administration (USFDA).

"The approval demonstrates Lupin's commitment to building its brand franchise in the US," said Vinita Gupta, chief executive officer.

Lupin Pharmaceuticals Inc., the company's US subsidiary, would commence marketing the product shortly, the company said in a statement.

LPI currently markets Antara capsules in strengths of 43 mg and 130 mg in the US market.

The new drug would be manufactured by Lupin.

Antara capsules are prescribed for treatment of high blood cholesterol, mixed dyslipidemia and high triglycerides in combination with diet.

As per the IMS MAT June 2013 data, the market in the US for fenofibrate is valued close to $1.5 billion.