Drug news

CHMP recommends Intuniv (guanfacine hydrochloride extended release) for ADHD

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Last updated:23rd Jul 2015

Published:23rd Jul 2015

Source: Pharmawand

Shire plc announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of the once-daily, non-stimulant Intuniv (guanfacine hydrochloride extended release; GXR) for the treatment of attention deficit/hyperactivity disorder (ADHD) in children and adolescents. The CHMP’s positive opinion is based on results from three Phase III pivotal studies investigating the short- and long-term safety and efficacy of Intuniv in children and adolescents with ADHD.

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