USFDA grants Sun Pharma subsidiary approval for generic Strattera capsules ANDA

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Sep 2 2010

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Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE:SUNPHARMA, BSE: 524715) announced that USFDA has granted its subsidiary an approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Strattera ®, atomoxetine hydrochloride capsules.

These generic atomoxetine hydrochloride capsules are equivalent to Eli Lilly's Strattera ® capsules and include six strengths: 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, and 100 mg.

Annual sale in US for these strengths of branded and generic atomoxetine hydrochloride capsules is estimated at over $ 530 million.

Atomoxetine Hydrochloride capsules are indicated for the management of attention deficit hyperactivity disorder in children aged 6 and older,teens and adults.

Source:

Sun Pharma

Posted in: Child Health News | Medical Condition News | Pharmaceutical News

Tags: Atomoxetine, Attention Deficit Hyperactivity Disorder (ADHD), Cardiology, Children, Gastroenterology, Hyperactivity, Neurology, New Drug Application, Pharmaceuticals, Psychiatry

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