LUPIN WINS TENTATIVE APPROVAL FOR GENERIC ZOLOFT

Lupin Pharmaceuticals announced that the FDA has granted tentative approval to the company's abbreviated new drug application (ANDA) for sertraline HCl tablets, 25, 50 and 100 mg. Final approval is expected upon the expiration of the first ANDA filer's 180-day marketing exclusivity in February.

Upon final approval, Lupin's product will be the AB-rated generic equivalent of Pfizer's Zoloft, indicated for the treatment of major depressive disorder. The brand product had annual sales of approximately $3.1 billion for the year ending in July, Lupin said, citing IMS sales data.

Teva Pharmaceutical Industries launched its generic version Zoloft in 25-, 50- and 100-mg doses in August 2006. As the first generic drugmaker to successfully challenge the Zoloft patent, Teva is the only generic drugmaker allowed to sell those doses of the drug during the six months following the launch.