Lupin receives USFDA approval for its sNDA on Antara Capsules

22 Oct 2013 Evaluate

Pharmaceutical Major, Lupin 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 (LPI), the company's US subsidiary would 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

Lupin is an innovation led transnational pharmaceutical company producing and developing a wide range of branded and generic formulations and APIs globally.

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