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Shire says US FDA approves Mydayis for ADHD

21 June 2017 07:23

Shire said the US FDA has approved Mydayis, a once-daily treatment comprised of three different types of drug-releasing beads for patients 13 years and older with Attention Deficit Hyperactivity Disorder (ADHD).

Mydayis was not for use in children 12 years and younger. Shire expected to make Mydayis commercially available in the US in the third quarter of 2017.

The FDA approval of Mydayis was based on results from 16 clinical studies evaluating it in more than 1600 subjects, including adolescents (aged 13 to 17 years) and adults with ADHD.

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