Lupin Receives USFDA Approval For Escitalopram Oxalate Tablets
Lupin Pharmaceuticals has received tentative approval for ANDA for Escitalopram Oxalate Tablets 10 mg and 20 mg from USFDA.
Lupin's Escitalopram tablets are the AB-rated generic equivalent of Forest Laboratories' Lexapro tablets, indicated for the treatment of major depressive disorder. The brand product had annual sales of approximately $2.6 billion for the twelve months ended March 2008, based on IMS Health sales data.
Commenting on the approval, Vinita Gupta, President and Managing Director of Lupin Pharmaceuticals, Inc. said, "We are pleased to receive this tentative approval and look forward to bringing Escitalopram tablets to the US market as an affordable generic alternative post patent expiry."
The product will be introduced in the market through LPI's strong network of national wholesalers and drug stores post patent expiry in March 2012. This will strengthen Lupin's presence in the Selective Serotonin Reuptake Inhibitor (SSRI) segment.
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 has secured global leadership position in Anti-TB and Cephalosporins and has a significant presence in the areas of Cardiovasculars (prils and statins), Diabetology, Asthma and NSAIDs.
The Company's R&D endeavors have resulted in significant progress in its NCE program. The Company's foray into New Drug Delivery Systems has resulted in the development of platform technologies that are being used to develop value-added generic pharmaceuticals.