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Sun Pharma Gets USFDA Approval For Generic Strattera Capsules

September 1, 2010, Wednesday, 12:20 GMT | 07:20 EST | 16:50 IST | 19:20 SGT

(RTTNews) - Sun Pharmaceutical Industries Ltd. said it had obtained approval from USFDA for its Abbreviated New Drug Application or ANDA to market a generic version of Strattera hydrochloride capsules, with 180 days marketing exclusivity.

The company said these generic atomoxetine hydrochloride capsules are equivalent to Eli Lily's Strattera capsules, and include six strengths??”10mg, 18 mg, 25mg, 40mg 60mg and 100mg.

Atomoxetine hydrochloride capsules are indicated for the management of attention deficit hyperactivity disorder in children aged six and older, teens and adults. Annual sales in the US for these strengths of branded and generic atomoxetine hydrochloride capsules is estimated at over $530 million, it added.

At the BSE, Sun Pharma shares are currently trading at Rs.1,746.30, down by 0.78% from the previous close.