Lupin Ltd. Receives FDA Approval for Generic LYRICA(R)
Published: Jul 05, 2012
MUMBAI and BALTIMORE, July 5, 2012 /PRNewswire/ --
Pharma major, Lupin Ltd., announced today that its subsidiary, Lupin Pharmaceuticals Inc. (collectively, Lupin) has received final approval for its Pregabalin Capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg from the United States Food and Drugs Administration (FDA) to market a generic version of C.P. Pharmaceuticals C.V., LYRICA® (Pregabalin) capsules.
Lupin's Pregabalin Capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg are the AB-rated generic equivalent of LYRICA® capsules, which is indicated for neuropathic pain associated with diabetic peripheral neuropathy, post herpetic neuralgia, adjunctive therapy for adult patients with partial onset seizures and fibromyalgia.
LYRICA® Capsules had annual U.S sales of approximately $1.8 billion for the twelve months ending March 2012 (IMS Health Sales Data).
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 (5.3% 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.
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Head - Corporate Communications
*LYRICA® is a registered trademark of C.P. Pharmaceuticals, C.V. a wholly owned subsidiary of Pfizer, Inc.
SOURCE Lupin Ltd