Hyderabad: Aurobindo Pharma Limited has received the US FDA's tentatively approval for its 'sertraline hydrochloride' ANDA. The company will make the drug in tablet form in 25mg, 50mg and 100 mg.

The drug can be marketed in the US market after the expiry of the SetraHne hydrochloride product patent and also upon final approval from US FDA.

This is an important approval for Aurobindo Pharma in terms of its R&D capabilities it has been able to demonstrate that the generic drug product is equivalent to and has the same therapeutic effect as the innovator product, Zoloft of Pfizer Inc.-

Aurobindo is a1ready selling three formulations in the US. It's strategy is to penetrate the US market.