Ltd. announced that the US FDA has approved the company's Abbreviated New Drug Application (ANDA) for sertraline hydrochloride tablets, 25mg, 50mg and 100mg.
Sertraline hydrochloride is indicated for the treatment of major depressive disorder.
According to a Lupin press release, sertraline tablets are the AB-rated generic equivalent of Pfizer's zoloft tablets. The brand product had annual sales of approximately US$2.1 billion for the 12-month period ended December 2006, according to IMS Health.
With this approval, Lupin now has 18 ANDAs approved by the US FDA.