Lupin Ltd., a Mumbai based pharmaceutical company, announced that the US FDA has granted tentative approval for 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.
Lupin's Sertraline Hydrochloride tablets will be the AB-rated generic equivalent of Pfizer's Zoloft tablets. Annual product sales in the U S of the tablets were approximately $3.1 billion for the twelve months ended July 2006, based on IMS data, a Lupin press release stated.
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.