Lupin gets tentative US FDA approval for Sertraline

Mumbai, Jan 2: Lupin Ltd today announced that US FDA has granted tentative approval for the company's Abbreviated New Drug Application (ANDA) for Sertraline Hydrochloride Tablets, 25mg, 50mg and 100 mg.

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

Annual product sales in US of the tablets were approximately USD 3.1 billion for the twelve months ended July 2006, based on IMS data, the release said.

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 the company's eighteenth ANDA approval till date, the release added.

UNI