Lupin has received final approval for its supplemental New Drug Application (sNDA) for Antara (Fenofibrate) capsules, 30 mg and 90 mg strengths from the United States Food and Drug Administration (US FDA). Lupin Pharmaceuticals, the company’s US subsidiary 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.
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 said, “We are 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.”
EP News Bureau – Mumbai