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FDA Approves Additional Dosage Strengths of Shire's ADHD Treatment VYVANSE(TM) (lisdexamfetamine dimesylate) Which May Help Physicians Tailor Treatment for Individual Patients
Date:1/3/2008

verage for VYVANSE will continue to improve as we move into 2008."

VYVANSE is currently approved in the United States for the treatment of ADHD in children aged 6 to 12 years. A Supplemental New Drug Application (sNDA) for VYVANSE for the treatment of ADHD in adults is currently under review by the FDA.

VYVANSE is a therapeutically inactive prodrug, in which d-amphetamine is covalently bonded to l-lysine, and after oral ingestion it is converted to pharmacologically active d-amphetamine. The conversion of VYVANSE to d- amphetamine is not affected by gastrointestinal pH and is unlikely to be affected by alterations in normal GI transit times.

Additional information about VYVANSE and Full Prescribing Information are available at http://www.vyvanse.com.

About ADHD

Approximately 7.8 percent of all school-age children, or about 4.4 million U.S. children aged 4 to 17 years, have been diagnosed with ADHD at some point in their lives, according to the U.S. Centers for Disease Control and Prevention (CDC). ADHD is one of the most common psychiatric disorders in children and adolescents. The disorder is also estimated to affect 8.1 percent of adults, or approximately 9.2 million adults across the U.S. based on a retrospective survey of adults aged 18 to 44, projected to the full U.S. adult population. ADHD is a neurobiological disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity that is more frequent and severe than is typically observed in individuals at a comparable level of development. To be properly diagnosed with ADHD, a child needs to demonstrate at least six of nine symptoms of inattention; and/or at least six of nine symptoms of hyperactivity/impulsivity; the onset of which appears before age 7 years; that some impairment from the symptoms is present in two or more settings (e.g., at school and home); that the symptoms continue for at least
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SOURCE Shire plc
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