Lupin Pharmaceuticals, Inc. (LPI) announced today that it has received tentative approval for the Company's Abbreviated New Drug Application (ANDA) for Escitalopram Oxalate Tablets 10 mg and 20 mg from the U.S. Food and Drug Administration (USFDA).
Lupin's Escitalopram tablets are the AB-rated generic equivalent of Forest Laboratories' Lexapro(R) 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.
source:www.pharmalive.com
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