Aurobindo Pharma Ltd on Tuesday said it has received tentative approval from the US FDA for its Sertraline Hydrochloride ANDA for tablets of 25 mg (base), 50 mg (base) and 100 mg (base).
The company will be able to market this product in the US after the expiry of the Sertraline Hydrochloride product patent and also upon final approval from US FDA, it informed the Bombay Stock Exchange.
US FDA has termed its generic drug product to be bio-equivalent and have the same therapeutic effect to the innovator product, namely Zoloft of Pfizer Inc, it said.
The company is already selling three formulations in the US and the strategy is kept right to penetrate the US market, it added.