BALTIMORE, March 22 /PRNewswire/ -- Lupin Pharmaceuticals, Inc. (LPI) announced today that it has received tentative approval for the Company's Abbreviated New Drug Application (ANDA) for Eszopiclone tablets, 1 mg, 2 mg and 3 mg from the U.S. Food and Drug Administration (USFDA).
Commenting on the approval, Vinita Gupta, President and CEO of Lupin Pharmaceuticals, Inc., said, "We are pleased to receive this tentative approval and look forward to bringing Eszopiclone tablets to the US market as an affordable generic alternative post patent expiry."
About Lupin
Headquartered in Mumbai, India, Lupin Limited is an innovation led transnational pharmaceutical company producing a wide range of quality, affordable generic and branded formulations and APIs for the developed and developing markets of the world. The Company today has significant market share in key markets in the Cardiovasculars (prils and statins), Diabetology, Asthma, Pediatrics, CNS, GI, Anti-Infectives and NSAIDs therapy segments, not to mention global leadership positions in the Anti-TB and Cephalosporins. The Company's R&D endeavors have resulted in significant progress in its NCE program. The Company's foray into Advanced Drug Delivery Systems has resulted in the development of platform technologies that are being used to develop value-added generic pharmaceuticals.
Lupin Pharmaceuticals, Inc. is the U.S. wholly owned subsidiary of Lupin Limited. Through its sales and marketing headquarters in Baltimore, Maryland, Lupin Pharmaceuticals, Inc. is dedicated to delivering high-quality, affordable generic medicines trusted by healthcare professionals and patients across geographies. For more information, visit http://www.lupinpharmaceuticals.com.
*LUNESTA(R) is a registered trademark of Sepracor, Inc.
CONTACT: Edith St-Hilaire, Director of Marketing of Lupin Pharmaceuticals,
Inc., +1-410-576-2000, Ext. 207, esthilaire@lupinusa.com
Web site: http://www.lupinworld.com/
