Lupin Receives FDA Approval for Generic Lexapro® Tablets
MUMBAI, India and BALTIMORE, Maryland, September 13, 2012 /PRNewswire/ --
Pharma major, Lupin Ltd., announced today that its subsidiary Lupin Pharmaceuticals Inc. (collectively, Lupin) has received final approval for its Escitalopram Tablets (Escitalopram oxalate) 5 mg, 10 mg, and 20 mg, from the United States Food and Drugs Administration (FDA) to market a generic version of Forest Laboratories, Inc.'s (Forest) Lexapro Tablets, 5 mg, 10 mg, and 20 mg.
Lupin's Escitalopram Tablets USP, 5 mg, 10 mg, and 20 mg is the AB-rated generic equivalent of Forest's Lexapro® Tablets and is indicated for acute and maintenance treatment of major depressive disorder in adults and adolescents aged 12-17 years. It is also indicated for the acute treatment of general anxiety disorder in adults.
Lexapro® Tablets had annual U.S sales of approximately USD 2.7 billion for the twelve months ending June, 2012 (IMS Health Sales Data). Lupin remains the 5th largest generics player in the US (5.5% market share by prescriptions, IMS Health), the only Asian company to achieve that distinction.
About Lupin Limited
Headquartered in Mumbai, Lupin is an innovation led transnational pharmaceutical company producing a wide range of generic and branded formulations and APIs. The Company today has significant presence in the Cardiovascular, Diabetology, Asthma, Paediatrics, CNS, GI, Anti-Infective and NSAID space in addition to holding global leadership positions in the Anti-TB and Cephalosporin segments.
Lupin is the 5th largest and fastest growing generics player in the US (5.5 % market share by prescriptions, IMS Health), the only Asian company to achieve that distinction. The company is also the fastest growing top 10 pharmaceutical player in India, Japan and South Africa (IMS).
For the financial year ended March 2012, Lupin's Consolidated Revenues and Profit after Tax were Rs.70,829 Million (USD 1.42 Billion) and Rs. 8,676 Million (USD 190 million) respectively. Please visit http://www.lupinworld.com for more information.
Lupin Pharmaceuticals, Inc. is the wholly owned U.S. subsidiary of Lupin Limited. 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.
Safe Harbor Statement
*Lexapro®is a registered trademark of Forest Laboratories, Inc.
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SOURCE Lupin Ltd