Sun Pharma receives US FDA nod for hyperactivity drug

It has received approval to sell generic strattera capsules, used in treating attention deficit hyperactivity disorder, in the American market

By PTI | Sep 01, 2010, 04.38 PM IST

NEW DELHI: Drug maker Sun Pharmaceutical Industries today said it has received approval from the US health regulator to sell generic strattera capsules, used in treating attention deficit hyperactivity disorder, in the American market.

The company'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, Sun Pharma said in a filing to Bombay Stock Exchange.

The company has received 180 days marketing exclusivity for these atomoxetine hydrochloride capsules, it said.

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.

Atomoxetine hydrochloride capsules are indicated in the treatment of attention deficit hyperactivity disorder in children aged six and above, teens and adults.

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