Lupin Ltd. Receives FDA Approval for its New Drug Application for Antara® Capsules
Published: Oct 23, 2013
Lupin Receives FDA Approval for its New Drug Application for Antara® Capsules
MUMBAI, India and BALTIMORE, October 22, 2013 /PRNewswire/ --
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."
About Lupin Limited
Lupin is an innovation-led transnational pharmaceutical company producing and developing a wide range of branded and generic formulations and APIs globally. The Company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds global leadership positions in the Anti-TB and Cephalosporin segment.
Lupin is the 5th largest and fastest growing top 5 generics player in the US (5.3% market share by prescriptions, IMS Health) and the 3rd largest Indian pharmaceutical company by sales. The Company is also the fastest growing top 10 generic pharmaceutical players in Japan and South Africa (IMS).
For the financial year ended March 2013, Lupin's Consolidated turnover and Profit after Tax were Rs. 94,616 million (USD 1.74 billion) and Rs. 13,142 million (USD 242 million) respectively. Please visit http://www.lupinworld.com for more information.
Headquartered in Baltimore, Maryland, Lupin Pharmaceuticals, Inc. is dedicated to delivering high-quality, affordable generic medicines and branded formulations trusted by healthcare professionals and patients across geographies. For more information, visit http://www.lupinpharmaceuticals.com
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