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FDA approval for generics of ADHD drug Strattera Posted 23/06/2017

The US Food and Drug Administration announced on 30 May 2017 the approval of the first generic versions of Strattera (atomoxetine).

Generics makers Apotex, Teva Pharmaceuticals (Teva), Aurobindo Pharma and Glenmark Pharmaceuticals all gained approval to market generic atomoxetine in dosages of 10, 18, 25, 40, 60, 80 and 100 mg.

Atomoxetine is a norepinephrine (noradrenaline) reuptake inhibitor, which is approved for the treatment of attention deficit hyperactivity disorder (ADHD). The disorder is marked by an ongoing pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development. ADHD is the most common neurobehavioral disorder diagnosed in children in the US. ADHD affects one in 10 US children and half of these children are diagnosed by the age of six.

The originator drug, Eli Lilly’s Strattera, had sales of approximately US$1.1 billion for the 12-month period ending April 2017, according to IMS Health data.

The first generics of ADHD drugs hit the US market in June 2015, when Mylan, Par Pharmaceuticals, Sandoz and Teva launched generic versions of Shire Pharmaceutical’s Intuniv (guanfacine) [1].

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1. GaBI Online - Generics and Biosimilars Initiative. Generics of ADHD drug launched in US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jun 23]. Available from: www.gabionline.net/Generics/News/Generics-of-ADHD-drug-launched-in-US

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Source: Glenmark, US FDA

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