Drug maker Lupin Ltd. said on Tuesday it had received tentative approval from the U.S. Food and Drug Administration for sertraline hydrochloride tablets in multiple strengths.
Sertraline, the generic equivalent of Pfizer Inc.'s Zoloft, is used to treat disorders including depression and anxiety. Annual sales of Zoloft tablets in the United States were estimated at about $3.1 billion, Lupin said.
Lupin said it expected final FDA approval to be granted on expiration of the marketing exclusivity for Zoloft in February.
Shares in Lupin were flat at 612 rupees in a firm Mumbai market.
