Aurobindo receives tentative FDA nod for Sertraline Hydrochloride tabs
The US FDA has tentatively approved Aurobindo Pharma's Sertraline Hydrochloride ANDA for Tablets 25 mg, 50 mg and 100 mg.
The company will be able to market this product in the US market after the expiry of the Setraline hydrochloride product patent and also upon final approval from US FDA. The innovator product is Zoloft of Pfizer Inc.