Sun Pharma receives US FDA nod for hyperactivity drug

02 Sep 2010 Evaluate

Sun Pharma’s subsidiary has received abbreviated new drug application approval from the US Food and Drug Administration to market generic atomoxetine hydrochloride capsules in strengths of 10 mg ,18 mg ,25 mg, 40 mg, 60 mg and 100 mg.The company has received 180 days marketing exclusivity for these atomoxetine hydrochloride capsules. 

Atomoxetine hydrochloride capsules are indicated in the treatment of attention deficit hyperactivity disorder.The generic atomoxetine capsules are equivalent to Eli Lilly's strattera capsules and the annual sales of both branded and generics is estimated to be over USD 530 million in the US market. 

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