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Shire to Initiate Two Phase 4 Clinical Trials to Compare Vyvanse® (lisdexamfetamine dimesylate) Capsules, (CII) to Concerta® (methylphenidate HCl) Extended-Release Tablets, (CII)
Date:3/6/2012

sdexamfetamine dimesylate)

Vyvanse, which was introduced in the United States in July 2007 for the treatment of ADHD in children ages 6 to 12 years, approved in April 2008 to treat ADHD in adults, and approved in November 2010 to treat ADHD in adolescents ages 13 to 17, is currently available in six once-daily dosage strengths of 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg.

Additional information about Vyvanse is available at http://www.vyvanse.com.

INDICATION

Vyvanse is indicated for the treatment of ADHD in patients ages 6 and above as part of a total treatment plan that may include other measures (psychological, educational, social). Efficacy was established in short-term controlled studies in children aged 6 to 17 and adults. Vyvanse is also approved as a maintenance treatment for adults with ADHD based on one randomized withdrawal study. Extended use of Vyvanse should be periodically reevaluated to determine its long-term usefulness for the individual patient.

IMPORTANT SAFETY INFORMATION

WARNING: POTENTIAL FOR MISUSE, ABUSE, ADDICTION, AND DIVERSION

See Full Prescribing Information for complete Boxed WARNING.

• Vyvanse is a Schedule II controlled substance. Stimulants, such as amphetamines and methylphenidates, are subject to misuse, abuse, addiction, and criminal diversion.

• Misuse of amphetamines may cause sudden death and serious cardiovascular adverse events.

Contraindications: Known hypersensitivity to amphetamines or other ingredients in Vyvanse.

Anaphylactic reactions, Stevens-Johnson Syndrome, angioedema, and urticaria have been observed in postmarketing reports. Using Vyvanse with monoamine oxidase inhibitors (MAOIs) can result in hypertensive crisis. Stop MAOIs at least 14 days prior to Vyvanse use.

Sudden death, stroke and myocardial infarction have
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