FDA issues final approval for Lupin's sNDA for Antara capsules

Oct 23 2013

Pharma Major Lupin Limited (Lupin) announced today that it has received final approval for its supplemental New Drug Application (sNDA) for Antara® (Fenofibrate) capsules, 30 mg & 90 mg strengths from the United States Food and Drug Administration (FDA). Lupin Pharmaceuticals Inc. (LPI), the company's US subsidiary, will commence marketing the product shortly. LPI currently markets and promotes Antara® Capsules, 43 mg & 130 mg strengths. The new drug would be manufactured by Lupin.

Lupin's Antara® capsules enjoy strong brand equity with primary care physicians treating patients for high LDL-C, Total-C, triglycerides, Apo-B and low HDL-C. Antara® capsules are prescribed for adjunct treatment of hypercholesterolemia (high blood cholesterol), mixed dyslipidemia and hyper-triglyceridemia (high triglycerides) in combination with diet.

Commenting on the approval, Vinita Gupta, Chief Executive Officer, Lupin Limited, 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."