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PHILADELPHIA — The Food and Drug Administration has approved a new use for a Shire drug to treat attention deficit hyperactivity disorder, Shire said Monday.
The FDA approved Intuniv (guanfacine) as an add-on therapy for children and adolescents already taking stimulants to treat ADHD, also known as an adjunctive therapy.
The approval was based on a nine-week placebo-controlled study of the drug in which children and adolescents received it in combination with a stimulant.