Lupin gets tentative USFDA approval for Sertraline

New Delhi, Jan 2 (UNI) Pharmaceutical company Lupin Ltd today said the United States Food and Drug Administration (USFDA) has granted tentative approval to its Abbreviated New Drug Application (ANDA) for Sertraline Hydrochloride tablets.

The company's Sertraline Hydrochloride Tablets will be the AB-rated generic equivalent of Pfizer's ZOLOFT tablets. The drug is indicated for the treatment of major depressive disorder.

Annual product sales of the tablets in the US is estimated at 3.1 billion dollars for the twelve months ended July 2006, based on IMS data.

The company 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 its eighteenth ANDA approval till date.

UNI