Lupin Pharmaceuticals has received tentative approval from the FDA for the company's abbreviated new drug application for Escitalopram oxalate tablets 10mg and 20mg.
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Lupin’s Escitalopram tablets are the AB-rated generic equivalent of Forest Laboratories’s Lexapro tablets, indicated for the treatment of major depressive disorder.
The product will be introduced in the market through Lupin’s network of national wholesalers and drug stores post patent expiry in March 2012. This is expected to strengthen Lupin’s presence in the selective serotonin reuptake inhibitor segment.
Vinita Gupta, president and managing director of Lupin, 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.”
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