Lupin Ltd said that the US FDA has tentatively approved its generic sertraline hydrochloride tablets, 25mg, 50mg, and 100 mg, for the treatment of major depressive disorder.
Sertraline hydrochloride pills from Lupin are the generic equivalent of Pfizer’s Zoloft. Its yearly sales in the United States were roughly $3.1 billion for the fiscal year ended July 2006, according to a business announcement citing statistics from market research firm IMS.
Lupin plans to commercialise the generic after final approval, which is expected when the Pfizer product’s marketing exclusivity expires in February 2007. This is the company’s eighteenth approved abbreviated new medication application.