Pharma major Lupin Limited has received final approval for its supplemental new drug application (NDA) for Antara (fenofibrate) capsules, 30 mg and 90 mg strengths from the US Food and Drug Administration (FDA). Lupin's US subsidiary, Lupin Pharmaceuticals Inc. (LPI), would commence marketing the product shortly.
LPI currently markets and promotes Antara capsules 43 mg and 130 mg strengths. The new drug would be manufactured by Lupin.
Commenting on the approval Vinita Gupta, chief executive officer, Lupin said, “We are very pleased to receive this approval. The approval demonstrates Lupin's commitment to building its brand franchise in the US. Our sales and marketing efforts will commence shortly.
Lupin's Antara capsules enjoy strong brand equity with primary care physicians treating ptients for high LDL-C, Total-C, triglycerides, Apo-B and low HDL-C. Antara capsules are prescribed for adjunct treatment of hypercholesterolemia (high blood cholestrol), mixed dyslipidemia and high-triglyceridemia (high triglycerides) in combination with diet.