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FDA Approves INTUNIV® (guanfacine) Extended-Release Tablets for Use as Adjunctive Therapy to Stimulants for the Treatment of ADHD in Children and Adolescents
Date:2/28/2011

PHILADELPHIA, Feb. 28, 2011 /PRNewswire/ -- Shire plc, (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, today announced that the US Food and Drug Administration (FDA) approved the use of once-daily INTUNIV® (guanfacine) Extended-Release Tablets as adjunctive therapy to stimulants for the treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents ages 6 to 17 as part of a total treatment program. The approval is based on results from a 9-week placebo-controlled study of INTUNIV when given in combination with a stimulant, in children and adolescents with ADHD.(1)

"This approval of INTUNIV for treating ADHD as adjunctive therapy to a stimulant offers physicians a new treatment option for children and adolescents with ADHD who are having a suboptimal response to their current stimulant therapy," said Robert Findling, MD, Director of Child & Adolescent Psychiatry at University Hospitals Case Medical Center and Professor of Psychiatry & Pediatrics at Case Western Reserve University School of Medicine, a lead investigator for the study. "In this study, the once-daily dosing of INTUNIV was effective when taken in the morning or the evening, giving physicians flexibility when it comes to treating their patients with ADHD."

INTUNIV is indicated for the treatment of ADHD as monotherapy and as adjunctive therapy to stimulant medications in children and adolescents ages 6 to 17. The effectiveness of INTUNIV for more than 9 weeks has not been systematically evaluated. The physician electing to use INTUNIV for extended periods should periodically reevaluate its long-term usefulness for the individual patient. INTUNIV is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educati
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