MUMBAI, India and BALTIMORE, March 21, 2014 /PRNewswire/ --
Pharma Major Lupin Limited (Lupin) announced today that its US subsidiary, Lupin Pharmaceuticals Inc. has launched its Niacin Extended-Release Tablets USP, 500 mg, 750 mg, 1000 mg strengths having received final approval from the United States Food and Drug Administration (FDA) yesterday.
Lupin's Niacin Extended-Release Tablets USP, 500 mg, 750 mg, 1000 mg strengths are the AB-rated generic equivalent of AbbVie Inc.'s Niaspan® Tablets 500 mg, 750 mg, 1000 mg and used with diet to reduce elevated TC, LDL-C, Apo B and TG levels, and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia.
Niaspan® Tablets had annual U.S sales of approximately USD 1 billion (IMS MAT Dec, 2013).
Commenting on the approval Ms. Vinita Gupta, Chief Executive Officer, Lupin Limited said, "We are happy to launch this product having received approval from the FDA yesterday. The launch bears testimony to our commitment to serving our customers and patients by bringing high quality, affordable medicines to the market."
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 revenues. 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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Safe Harbor Statement* Niaspan® is a registered trademark of AbbVie Inc.
SOURCE Lupin Ltd