Lupin awarded tentative US FDA approval for sertraline

Lupin Ltd has announced that the US FDA has granted tentative approval for its abbreviated new drug application (ANDA) for sertraline hydrochloride tablets in 25mg, 50mg and 100mg dosages. Sertraline hydrochloride is indicated for the treatment of major depressive disorders.

Lupin''s sertraline hydrochloride tablets will be the AB-rated generic equivalent of Pfizer''s Zoloft tablets. Annual sales for the medication in the US during 2006 were approximately $3.1 billion (IMS data).

The company now intends to launch the generic on final approval, which is expected upon expiration of the marketing exclusivity for the product in February 2007. This is Lupin''s eighteenth ANDA approval.