Sun Pharmaceutical Industries Ltd on Thursday said it has got tentative approval from the US Food and Drug Administration for its generic product Strattera, used in the treatment of mental disorders.
The drug regulator has approved Strattera atomoxetine hydrochloride capsules, which is equivalent to drug manufacturer Eli Lilly's Strattera capsules.
The company has received 'abbreviated new drug application' certification for the drug, Sun Pharma said in a filing to the Bombay Stock Exchange.
The capsules are available in seven strengths--10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg, the Mumbai-based drug maker said. The capsules, used in the treatment of attention deficit hyperactivity disorder, have annual sales of nearly $500 million in the US.